Haemophilus Influenzae Type bPhase 3NCT00289783

Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine

A Phase 3 study testing GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine, ActHIB and PedvaxHIB in people with Haemophilus Influenzae Type b and Neisseria Meningitidis, run by GlaxoSmithKline at 93 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 6 weeks to 15 monthsHealthy volunteers can take part
Conditions the study is for: Haemophilus Influenzae Type b, Neisseria Meningitidis
What is being tested?: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine, ActHIB and PedvaxHIB
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4,441 participants
Where: 93 sitesin 3 countries
Study dates: 22 Feb 2006to 26 Feb 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 weeks to 15 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol
A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
Written informed consent obtained from the parent or guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Born after 36 weeks gestation.
Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrollment.
Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine.

Who cannot join

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s). (Synagis® [palivizumab, MedImmune], Prevnar (Prevenar), rotavirus vaccine, and influenza vaccine are allowed.
Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).

Show all 22Show fewer

History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures.
Acute disease at time of enrollment.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Additional specific criteria for the US subjects in Cohort 1. In addition, for Cohorts 2 and 3, subjects should not be administered M-M-R II and Varivax if any of these criteria apply:
History of measles, mumps, rubella or varicella.
Previous vaccination against measles, mumps, rubella or varicella.
Hypersensitivity to any component of the vaccines, including gelatin or neomycin.
Patients receiving immunosuppressive therapy.
Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
Individuals with primary and acquired immunodeficiency states.
Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
Individuals with active tuberculosis.
Acute disease at time of booster vaccination.

Trial locations and contacts

93 sites in 3 countries.

Country

City, postcode or hospital

93 sites in 3 countries

United States88 sites

GSK Investigational Site
Amarillo, Texas, 79124
GSK Investigational Site
Arkansas City, Kansas, 67005
GSK Investigational Site
Baltimore, Maryland, 21201
GSK Investigational Site
Bardstown, Kentucky, 40004
GSK Investigational Site
Beaver Falls, Pennsylvania, 15010
GSK Investigational Site
Birmingham, Alabama, 35216
GSK Investigational Site
Birmingham, Alabama, 35235
GSK Investigational Site
Boardman, Ohio, 44512
GSK Investigational Site
Bossier City, Louisiana, 71111
GSK Investigational Site
Boston, Massachusetts, 02118
GSK Investigational Site
Brainerd, Minnesota, 56401
GSK Investigational Site
Bryant, Arkansas, 72011
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Charleston, South Carolina, 29406
GSK Investigational Site
Cleveland, Ohio, 44121
GSK Investigational Site
Cocoa Beach, Florida, 32931
GSK Investigational Site
Columbus, Ohio, 43205
GSK Investigational Site
Des Moines, Iowa, 50266
GSK Investigational Site
Des Moines, Iowa, 50309
GSK Investigational Site
Durham, North Carolina, 27705
GSK Investigational Site
Durham, North Carolina, 27710
GSK Investigational Site
East Artesia, California, 90706
GSK Investigational Site
Erie, Pennsylvania, 16501
GSK Investigational Site
Fall River, Massachusetts, 02724
GSK Investigational Site
Fayetteville, Arkansas, 72703
GSK Investigational Site
Fort Worth, Texas, 76107
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Fresno, California, 93710
GSK Investigational Site
Fresno, California, 93720
GSK Investigational Site
Fresno, California, 93726
GSK Investigational Site
Galveston, Texas, 77555-0188
GSK Investigational Site
Greenville, Pennsylvania, 16125
GSK Investigational Site
Gresham, Oregon, 97030
GSK Investigational Site
Hershey, Pennsylvania, 17033-0850
GSK Investigational Site
Huber Heights, Ohio, 45424
GSK Investigational Site
Ithaca, New York, 14850
GSK Investigational Site
Jamaica Plain, Massachusetts, 02130
GSK Investigational Site
Kalamazoo, Michigan, 49008
GSK Investigational Site
Kansas City, Kansas, 66160
GSK Investigational Site
La Crosse, Wisconsin, 54601
GSK Investigational Site
La Jolla, California, 92037
GSK Investigational Site
Layton, Utah, 84041
GSK Investigational Site
Lexington, Kentucky, 40503
GSK Investigational Site
Lexington, South Carolina, 29072
GSK Investigational Site
Little Rock, Arkansas, 72202
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Longmont, Colorado, 80501
GSK Investigational Site
Louisville, Kentucky, 40272
GSK Investigational Site
Mechanicsville, Virginia, 23111
GSK Investigational Site
Melbourne, Florida, 332901
GSK Investigational Site
Nampa, Idaho, 208 463 3126
GSK Investigational Site
New Hartford, New York, 13413
GSK Investigational Site
Norfolk, Virginia, 23510
GSK Investigational Site
North Las Vegas, Nevada, 89025
GSK Investigational Site
Norwich, Connecticut, 06360
GSK Investigational Site
Oakland, California, 94609
GSK Investigational Site
Omaha, Nebraska, 68131
GSK Investigational Site
Paramount, California, 90723
GSK Investigational Site
Pembroke Pines, Florida, 33024
GSK Investigational Site
Philadelphia, Pennsylvania, 19114
GSK Investigational Site
Phoenix, Arizona, 85003
GSK Investigational Site
Pittsburgh, Pennsylvania, 15212
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
GSK Investigational Site
Pleasant Grove, Utah, 84062
GSK Investigational Site
Portage, Michigan, 49024
GSK Investigational Site
Providence, Rhode Island, 02903
GSK Investigational Site
Raleigh, North Carolina, 27609
GSK Investigational Site
Rochester, New York, 14618
GSK Investigational Site
Rockledge, Florida, 32955
GSK Investigational Site
Rolling Hills Estates, California, 90274
GSK Investigational Site
Sacramento, California, 95817
GSK Investigational Site
Saint Paul, Minnesota, 55108
GSK Investigational Site
San Antonio, Texas, 78205
GSK Investigational Site
Sellersville, Pennsylvania, 18960
GSK Investigational Site
South Euclid, Ohio, 44121
GSK Investigational Site
South Jordan, Utah, 84095
GSK Investigational Site
St. George, Utah, 84790
GSK Investigational Site
Stevensville, Michigan, 49127
GSK Investigational Site
Stony Brook, New York, 11794
GSK Investigational Site
Sylva, North Carolina, 28779
GSK Investigational Site
Syracuse, New York, 13210
GSK Investigational Site
Temple, Texas, 76508
GSK Investigational Site
The Bronx, New York, 10467
GSK Investigational Site
Tulsa, Oklahoma, 74127
GSK Investigational Site
Vancouver, Washington, 98664
GSK Investigational Site
West Covina, California, 91790

Other trials in United States

Australia4 sites

GSK Investigational Site
Carlton, Victoria, 3053
GSK Investigational Site
Herston, Queensland, 4029
GSK Investigational Site
Randwick, New South Wales, 2031
GSK Investigational Site
South Brisbane, Queensland, 4101

Other trials in Australia

Mexico1 site

GSK Investigational Site
Mexico City, 06720

Other trials in Mexico

About this study

Official title: A Phase III, Randomized, Multinational Study, Double-blinded for the Immunogenicity and Consistency Evaluation of 3 Hib-MenCY-TT Vaccine Lots and Single-blinded and Controlled for the Evaluation of Safety and Immunogenicity of GSK Biologicals' Haemophilus Influenzae Type b and Neisseria Meningitidis Serogroups C and Y-tetanus Toxoid Conjugate Vaccine Combined (Hib-MenCY-TT) Compared to Monovalent Hib Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.

This study evaluates the immunogenicity and consistency of 3 Hib-MenCY-TT vaccine lots and the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age. The study will also evaluate the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with M-M-R® II and Varivax® at 12 to 15 months of age.

Read the detailed description

The subjects from this study will participate in one of three cohorts:

US Safety and Immunogenicity (Cohort 1): All immunogenicity analyses in the primary and booster phases will be evaluated in this cohort. These subjects will also contribute to the safety analyses in the primary and booster phases.
Safety Only (Cohort 2): Only safety objectives will be assessed in the primary and booster phases for this cohort.
Non-US Safety and Immunogenicity (Cohort 3): Only descriptive immunogenicity results in the primary and booster phases will be reported for this cohort. These subjects will also contribute to the safety analyses in the primary and booster phases.

Treatment allocation:

Primary phase: Subjects will be randomized with balanced allocation (1:1:1:1) to 1 of the 4 treatment groups and with a stratification according to the cohort. Assignment to a cohort will be based on study site.

Booster phase: Subjects who received Hib-MenCY-TT vaccine in the primary phase will receive a booster dose of Hib-MenCY-TT vaccine. Subjects who received ActHIB in the primary phase will receive a booster dose of PedvaxHIB.

During the 3-dose primary vaccination course, co-administration of Prevnar, Synagis, and/or rotavirus vaccine is permitted; co-administration of influenza vaccine is permitted at dose 3.

During the booster vaccination, co-administration of Prevnar, hepatitis A vaccine and influenza vaccine is permitted for all subjects in Cohort 1, 2 and 3; and co-administration of measles, mumps, rubella and varicella vaccine is permitted for all subjects in Cohort 2 and 3.

The study will be conducted in a double-blind fashion with regard to consistency of the 3 manufacturing lots of Hib-MenCY-TT vaccine and single-blind fashion for Hib-MenCY-TT vaccine versus monovalent Hib vaccine. The parents/guardians will be blinded up to collection of all data pertaining to the period up to one month after booster vaccination. Therefore, the extended safety follow-up after the booster dose will be conducted in an unblinded manner. The person administering the vaccines will ensure that the parent/guardian does not see the vaccine vial used in reconstituting the vaccine. Due to the differences in the presentations of the candidate Hib-MenCY-TT vaccine and control vaccines, it is not possible to blind study personnel who administer the vaccines.

Conditions: Haemophilus Influenzae Type b, Neisseria Meningitidis
Being tested: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine, ActHIB, PedvaxHIB, Pediarix, Prevnar
Keywords: Primary and booster vaccination, Neisseria meningitidis, Hib disease, Meningococcal vaccine, Meningococcal disease, Children, Immunogenicity, Safety, Infants
Medical subject headings: Haemophilus Infections, Meningococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccineBiological
3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.
ActHIBBiological
3-dose intramuscular injection at 2, 4 and 6 months of age.
PedvaxHIBBiological
1 booster dose by intramuscular injection at 12 to 15 months of age.
PediarixBiological
Also called Infanrix penta
3-dose intramuscular injection at 2, 4 and 6 months of age.
PrevnarBiological
3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.
M-M-R IIBiological
1 booster dose by subcutaneous injection at 12 to 15 months of age.
VarivaxBiological
1 booster dose by subcutaneous injection at 12 to 15 months of age

Study groups in NCT00289783
Study group	Role	What they receive
Menhibrix A Group	Experimental	Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm. Receives: Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine; Biological: Pediarix; Biological: Prevnar; Biological: M-M-R II; Biological: Varivax
Menhibrix B Group	Experimental	Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm. Receives: Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine; Biological: Pediarix; Biological: Prevnar; Biological: M-M-R II; Biological: Varivax
Menhibrix C Group	Experimental	Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm. Receives: Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine; Biological: Pediarix; Biological: Prevnar; Biological: M-M-R II; Biological: Varivax
Menhibrix Group	Experimental	Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm. Receives: Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine; Biological: Pediarix; Biological: Prevnar; Biological: M-M-R II; Biological: Varivax
ActHIB Group	Active comparator	Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm. Receives: Biological: ActHIB; Biological: PedvaxHIB

What is being measured

The primary outcome is the main question the study is designed to answer.

Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: One month after primary vaccination
Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers
Titers were expressed as Geometric Mean Titers (GMTs)
This analysis occured on the cohort 1 : Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: One month after primary vaccination
Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers
Titers are expressen as Geometric Mean Titers (GMTs)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: One month after primary vaccination
hSBA-MenC Antibody Titers
Titers are expressed as Geometric Mean Titers (GMTs)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: Prior to the fourth dose vaccination and 42 days after the fourth dose
hSBA-MenY Antibody Titers
Titers are expressed as Geometric Mean Titers (GMTs)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: Prior to the fourth dose vaccination and 42 days after the fourth dose
Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: One month after primary vaccination
Number of Subjects With hSBA-MenC Titer Equal to or Above 1:8
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: 42 days after the fourth dose
Number of Subjects With hSBA-MenY Titer Equal to or Above 1:8
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: 42 days after the fourth dose
Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 150 Milli-international Units Per Milli-liter (mIU/ML)
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL.
Co-administration with MMR-II vaccine
Measured: 42 days after the fourth dose
Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: 42 days after the fourth dose
Number of Subjects With Anti-mumps Titer Equal to or Above 28 Estimated Dose 50 (ED50)
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-mumps antibody titers below 28 ED50
Co-administration with MMR-II vaccine.
Measured: 42 days after the fourth dose
Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 10 International Units Per Milli-litre (IU/mL)
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 4 IU/mL.
Co-administration with MMR-II vaccine.
Measured: 42 days after the fourth dose
Number of Subjects With Anti-varicella Titer Equal to or Above 1:5
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody titer below 1:5.
Co-administration with Varivax vaccine.
Measured: 42 days after the fourth dose

Secondary outcomes (59)

Number of Subjects With Anti-tetanus (Anti-T) and Anti-diphtheria Toxoid (Anti-D) Antibody Concentrations Equal to or Above 0.1 International Units Per Millilitre (IU/mL)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: One month after primary vaccination
Anti-D and Anti-T Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in international units per milliliter (IU/mL).
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: One month after primary vaccination
Number of Subjects With Anti Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above 10.0 Milli-international Units Per Millilitre (mIU/mL)
Results are stratified by the presence or absence of a birth dose of hepatitis B vaccine.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: One month after primary vaccination
Anti-HBS Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in milli-International units per milliliter (mIU/mL)
Results are stratified by the presence or absence of a birth dose of hepatitis B vaccine.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: One month after primary vaccination
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5 ELISA Units Per Millilitre (EL.U/mL)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: One month after primary vaccination
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: One month after primary vaccination
Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Equal to or Above 8 Estimated Dose 50 (ED50)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: One month after primary vaccination
Anti-poliovirus Types 1, 2 and 3 Titers
Titers are expressed as Geometric Mean Titers (GMTs)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: One month after primary vaccination
Number of Subjects With Antibodies to Neisseria Meningitidis Serogroup C and Y Polysaccharide Capsule (Anti-PSC and Anti-PSY) Concentrations Equal to or Above the Cut-off Values
Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 microgram per milliliter (µg/mL) and >=2.0 µg/mL.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: One month after primary vaccination
Anti-PSC and Anti-PSY Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per milliliter (µg/mL)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: One month after primary vaccination
Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values
Anti-PRP antibody cut-off values assessed were >=0.15 microgram per milliliter (µg/mL) and >=1.0 µg/mL.
The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
Measured: One month after the primary vaccination course
Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values
Anti-PRP antibody cut-off values assessed were >=0.15 microgram per milliliter (µg/mL) and >=1.0 µg/mL.
The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
Measured: Prior to the fourth dose vaccination and one month after fourth dose vaccination
Anti-PRP Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL)
The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
Measured: One month after the primary vaccination course
Anti-PRP Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL)
The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
Measured: Prior to the fourth dose vaccination and one month after fourth dose vaccination
Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values
hSBA-MenC/Y antibody cut-off values assessed were >=1:4 and >=1:8
The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
Measured: One month after the primary vaccination course
Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values
hSBA-MenC/Y antibody cut-off values assessed were >=1:4 and >=1:8.
The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
Measured: Prior to the fourth dose vaccination and one month after fourth dose vaccination
hSBA-MenC and hSBA-MenY Antibody Titers
Titres are expressed as Geometric Mean Titers (GMTs).
The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
Measured: One month after the primary vaccination course
hSBA-MenC and hSBA-MenY Antibody Titers
Titers are expressed as Geometric Mean Titers (GMTs)
The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
Measured: Prior to the fourth dose vaccination and one month after fourth dose vaccination
Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values
Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 microgram per milliliter (µg/mL) and >=2.0 µg/mL.
The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
Measured: One month after the primary vaccination course
Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values
Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 µg/mL and >=2.0 µg/mL.
The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
Measured: Prior to the fourth dose vaccination and one month after fourth dose vaccination
Anti-PSC and Anti-PSY Antibodies Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per milliliter (µg/mL).
The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
Measured: One month after the primary vaccination course
Anti-PSC and Anti-PSY Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL).
The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
Measured: Prior to the fourth dose vaccination and one month after fourth dose vaccination
Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Value
Anti-PRP antibody cut-off values assessed were >=0.15 µg/mL.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: One month after the primary vaccination course
Anti-PRP Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL).
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: One month after the primary vaccination course and prior to the fourth dose vaccination
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values
hSBA-MenC and hSBA-MenY antibody cut-off values assessed were >=1:4 and >=1:8.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: One month after the primary vaccination course
Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values
Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 µg/mL and >=2.0 µg/mL.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: Prior to the fourth dose vaccination and 42 days after fourth dose vaccination
Anti-PSC and Anti-PSY Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL).
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: Prior to the fourth dose vaccination and 42 days after fourth dose vaccination
Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above 0.15 Microgram Per Milliliter (µg/mL)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: Prior to the fourth dose vaccination and 42 days after fourth vaccination
Anti-PRP Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: Prior to the fourth vaccination and 42 days after fourth vaccination
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Concentrations Equal to or Above 1:4
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: Prior to the fourth dose vaccination and 42 days after fourth vaccination
Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 200 Milli-international Units Per Millilitre (mIU/mL)
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: 42 days after fourth vaccination
Anti-measles Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in milli-international units per milliliter (mIU/mL).
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: 42 days after fourth vaccination
Number of Subjects With Anti-mumps Titer Equal to or Above the Cut-off Values
Anti-mumps antibody cut-off values assessed were >=28 estimated dose 50 (ED50) and >=51 ED50.
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-mumps antibody titers below 24 ED50.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: 42 days after fourth vaccination
Anti-mumps Antibody Titers
Titers are expressed as Geometric Mean Titers (GMTs).
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody titers below 24 ED50.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: 42 days after fourth vaccination
Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 4 International Units Per Millilitre (IU/mL)
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 4 IU/mL.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: 42 days after fourth vaccination
Anti-rubella Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in international units per milliliter (IU/mL).
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 4 IU/mL.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: 42 days after fourth vaccination
Number of Subjects With Anti-varicella Titer Equal to or Above 1:40
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 1:5
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: 42 days after fourth vaccination
Anti-varicella Antibody Titers
Titers are expressed as Geometric Mean Titers (GMTs)
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-varicella antibody titers below 1:5
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: 42 days after fourth vaccination
Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40
anti-H1N1, anti-H3N2 and anti-influenza-B (anti B) antibody were measured by hemagglutination inhibition assay (HIA), in subjects who received 2 doses of influenza vaccine within the same influenza season of which at least one dose is concomitant with the study vaccine. For the purposes of this study, concomitant administration of influenza vaccine was defined as administration within 28 days before to 7 days after administration of study vaccines.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based.
Measured: Prior to the fourth dose vaccination and one month after the fourth dose vaccination
Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit
Fever is defined as temperature (rectal or axillary/tympanic) above 39.5 degrees Celsius (°C) or 103.1 degrees Fahrenheit (°F).
Measured: In the 4-day (Day 0-3) follow-up period after primary vaccination course
Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit
Fever is defined as temperature (rectal or axillary/tympanic) above 39.5 degrees Celsius (°C) or 103.1 degrees Fahrenheit (°F).
Measured: In the 4-day (Day0-3) follow-up period after the fourth dose
Number of Subjects Reporting Solicited Local and General Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Solicited genral symptoms assessed were fever, irritability/fussiness, drowsiness and loss of appetite. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C.
Measured: Within the 4 days (Day 0-3) following each dose of the primary vaccination course
Number of Subjects Reporting Solicited Local and General Symptoms
Solicited local symptoms assessed were pain, redness, swelling and an increase in limb circumference. Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness and lost of appetite. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C
Measured: Within the 4 days (Day 0-3) post-vaccination period following the fourth dose
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Measured: Within 31 days (Day 0-30) following the primary vaccination course
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Measured: Within 31 days (Day 0-30) following the fourth dose
Number of Subjects Reporting Increased Circumferential Swelling at the Injection Limb(s)
Increased circumferential swelling defined as either swelling with a diameter of >50 mm or a >50 mm increase in the circumference of the mid-limb when compared to the baseline (pre-vaccination) measurement, or any diffuse swelling that interferes with or prevents everyday activities (for example, active playing, eating, sleeping).
Measured: Within 4 days (Day 0 to Day 3) after fourth dose vaccination
Number of Subjects Reporting General Symptoms Specific to Measles, Mumps, Rubella and Varicella Vaccination
Symptoms assessed were fever, rash/exanthem, parotid/salivary gland swelling, and any suspected signs of meningism including febrile convulsions. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C.
Measured: Within 43 days (Day 0 through Day 42) after vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Measured: From Dose 0 through 6 months after the last primary dose or untill administration of the fourth dose
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Measured: From the fourth dose through the end of the 6-month safety follow-up
Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Measured: From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose
Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Measured: From the fourth dose through the end of the 6-month safety follow-up
Number of Subjects Reporting Rash
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.
Measured: From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose
Number of Subjects Reporting Rash
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.
Measured: From the fourth dose through the end of the 6-month safety follow-up
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
Emergency room (ER) visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.
Measured: From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose
Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits.
Physicians (MD) office visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.
Measured: From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
Emergency room (ER) visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.
Measured: From the fourth dose through the end of the 6-month safety follow-up
Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits
Physicians (MD) office visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.
Measured: From the fourth dose through the end of the 6-month safety follow-up
Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL).
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: Prior to the fourth dose vaccination
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titer Equal to or Above 1:8.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Measured: Prior to the fourth dose vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Feb 200626 Feb 2008

First posted10 Feb 2006 (estimated)
Study start22 Feb 2006
Primary completion27 Aug 2007
Study completion26 Feb 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Haemophilus Influenzae Type bStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 4,441 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00289783
Sponsor's protocol ID: 103813
Other IDs: 105067
Status last verified: Nov 2016
First submitted: 9 Feb 2006
Last updated: 24 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90.
PubMed 21806393
Bryant KA, Marshall GS, Marchant CD, Pavia-Ruiz N, Nolan T, Rinderknecht S, Blatter M, Aris E, Lestrate P, Boutriau D, Friedland LR, Miller JM. Immunogenicity and safety of H influenzae type b-N meningitidis C/Y conjugate vaccine in infants. Pediatrics. 2011 Jun;127(6):e1375-85. doi: 10.1542/peds.2009-2992. Epub 2011 May 29.
PubMed 21624883
Bryant K, McVernon J, Marchant C, Nolan T, Marshall G, Richmond P, Marshall H, Nissen M, Lambert S, Aris E, Mesaros N, Miller J. Immunogenicity and safety of measles-mumps-rubella and varicella vaccines coadministered with a fourth dose of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine in toddlers: a pooled analysis of randomized trials. Hum Vaccin Immunother. 2012 Aug;8(8):1036-41. doi: 10.4161/hv.20357. Epub 2012 Aug 1.
PubMed 22617844
Bryant KA et al. Immune response to measles, mumps, rubella (MMR) and varicella (V) vaccine coadministered with a fourth dose of Haemophilus influenzae type b - Neisseria meningitidis serogroups C and Y - tetanus toxoid conjugate (HibMenCY) vaccine in toddlers. Abstract presented at the Annual meeting of Pediatric Academic Societies (PAS). Vancouver, Canada, 1-4 May 2010.
Rinderknecht S, Bryant K, Nolan T, Pavia-Ruz N, Doniz CA, Weber MA, Cohen C, Aris E, Mesaros N, Miller JM. The safety profile of Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY). Hum Vaccin Immunother. 2012 Mar;8(3):304-11. doi: 10.4161/hv.18752. Epub 2012 Feb 13.
PubMed 22327493

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Not yet recruitingPhase 3
Study Interchangeability Hep-B Vaccine Administered at Birth Dose
Vaccination Adverse Event, Immunogenicity, Vaccine
Active, not recruitingPhase 2/3
A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series
Diphtheria, Tetanus
Not yet recruitingPhase 3
Study of BK1803 in Healthy Infants
Pertussis, Diphtheria
Active, not recruitingPhase 1
Clinical Trial of Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine
Haemophilus Influenzae Type B Infection

All Haemophilus Influenzae Type b trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Multinational Study, Double-blinded for the Immunogenicity and Consistency Evaluation of 3 Hib-MenCY-TT Vaccine Lots and Single-blinded and Controlled for the Evaluation of Safety and Immunogenicity of GSK Biologicals' Haemophilus Influenzae Type b and Neisseria Meningitidis Serogroups C and Y-tetanus Toxoid Conjugate Vaccine Combined (Hib-MenCY-TT) Compared to Monovalent Hib Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.
ClinicalTrials.gov ID: NCT00289783
Acronym / sponsor ID: 103813
Conditions: Haemophilus Influenzae Type b, Neisseria Meningitidis
Keywords: Primary and booster vaccination, Neisseria meningitidis, Hib disease, Meningococcal vaccine, Meningococcal disease, Children, Immunogenicity, Safety
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 4,441 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 22 Feb 2006
Primary completion: 27 Aug 2007 (actual)
Study completion: 26 Feb 2008 (actual)
First posted: 10 Feb 2006 (estimated)
Results: Posted 6 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The subjects from this study will participate in one of three cohorts:

US Safety and Immunogenicity (Cohort 1): All immunogenicity analyses in the primary and booster phases will be evaluated in this cohort. These subjects will also contribute to the safety analyses in the primary and booster phases.
Safety Only (Cohort 2): Only safety objectives will be assessed in the primary and booster phases for this cohort.
Non-US Safety and Immunogenicity (Cohort 3): Only descriptive immunogenicity results in the primary and booster phases will be reported for this cohort. These subjects will also contribute to the safety analyses in the primary and booster phases.

Treatment allocation:

During the 3-dose primary vaccination course, co-administration of Prevnar, Synagis, and/or rotavirus vaccine is permitted; co-administration of influenza vaccine is permitted at dose 3.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5

Arm	Type	Receives
Menhibrix A Group	Experimental	Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine, Biological: Pediarix, Biological: Prevnar, Biological: M-M-R II, Biological: VarivaxSubjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
Menhibrix B Group	Experimental	Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine, Biological: Pediarix, Biological: Prevnar, Biological: M-M-R II, Biological: VarivaxSubjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
Menhibrix C Group	Experimental	Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine, Biological: Pediarix, Biological: Prevnar, Biological: M-M-R II, Biological: VarivaxSubjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
Menhibrix Group	Experimental	Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine, Biological: Pediarix, Biological: Prevnar, Biological: M-M-R II, Biological: VarivaxSubjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
ActHIB Group	Active comparator	Biological: ActHIB, Biological: PedvaxHIBSubjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.

Who may qualify

Ages: 6 weeks to 15 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (7 listed)

Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol
A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
Written informed consent obtained from the parent or guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Born after 36 weeks gestation.

Key exclusion criteria (22 listed)

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s). (Synagis® [palivizumab, MedImmune], Prevnar (Prevenar), rotavirus vaccine, and influenza vaccine are allowed.
Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.	Biological	Menhibrix A Group, Menhibrix B Group, Menhibrix C Group, Menhibrix Group
ActHIB3-dose intramuscular injection at 2, 4 and 6 months of age.	Biological	ActHIB Group
PedvaxHIB1 booster dose by intramuscular injection at 12 to 15 months of age.	Biological	ActHIB Group
PediarixAlso: Infanrix penta3-dose intramuscular injection at 2, 4 and 6 months of age.	Biological	Menhibrix A Group, Menhibrix B Group, Menhibrix C Group, Menhibrix Group
Prevnar3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.	Biological	Menhibrix A Group, Menhibrix B Group, Menhibrix C Group, Menhibrix Group
M-M-R II1 booster dose by subcutaneous injection at 12 to 15 months of age.	Biological	Menhibrix A Group, Menhibrix B Group, Menhibrix C Group, Menhibrix Group
Varivax1 booster dose by subcutaneous injection at 12 to 15 months of age	Biological	Menhibrix A Group, Menhibrix B Group, Menhibrix C Group, Menhibrix Group

Primary outcome

Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations
Time frame: One month after primary vaccination
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers
Time frame: One month after primary vaccination
Titers were expressed as Geometric Mean Titers (GMTs) This analysis occured on the cohort 1 : Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers
Time frame: One month after primary vaccination
Titers are expressen as Geometric Mean Titers (GMTs) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
hSBA-MenC Antibody Titers
Time frame: Prior to the fourth dose vaccination and 42 days after the fourth dose
Titers are expressed as Geometric Mean Titers (GMTs) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
hSBA-MenY Antibody Titers
Time frame: Prior to the fourth dose vaccination and 42 days after the fourth dose
Titers are expressed as Geometric Mean Titers (GMTs) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL)
Time frame: One month after primary vaccination
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Number of Subjects With hSBA-MenC Titer Equal to or Above 1:8
Time frame: 42 days after the fourth dose
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Number of Subjects With hSBA-MenY Titer Equal to or Above 1:8
Time frame: 42 days after the fourth dose
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 150 Milli-international Units Per Milli-liter (mIU/ML)
Time frame: 42 days after the fourth dose
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL. Co-administration with MMR-II vaccine
Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter
Time frame: 42 days after the fourth dose
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Number of Subjects With Anti-mumps Titer Equal to or Above 28 Estimated Dose 50 (ED50)
Time frame: 42 days after the fourth dose
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-mumps antibody titers below 28 ED50 Co-administration with MMR-II vaccine.
Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 10 International Units Per Milli-litre (IU/mL)
Time frame: 42 days after the fourth dose
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 4 IU/mL. Co-administration with MMR-II vaccine.
Number of Subjects With Anti-varicella Titer Equal to or Above 1:5
Time frame: 42 days after the fourth dose
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody titer below 1:5. Co-administration with Varivax vaccine.

59 secondary outcomes

Number of Subjects With Anti-tetanus (Anti-T) and Anti-diphtheria Toxoid (Anti-D) Antibody Concentrations Equal to or Above 0.1 International Units Per Millilitre (IU/mL)
Time frame: One month after primary vaccination
Anti-D and Anti-T Antibody Concentrations
Time frame: One month after primary vaccination
Number of Subjects With Anti Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above 10.0 Milli-international Units Per Millilitre (mIU/mL)
Time frame: One month after primary vaccination
Anti-HBS Antibody Concentrations
Time frame: One month after primary vaccination
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5 ELISA Units Per Millilitre (EL.U/mL)
Time frame: One month after primary vaccination
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Time frame: One month after primary vaccination
Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Equal to or Above 8 Estimated Dose 50 (ED50)
Time frame: One month after primary vaccination
Anti-poliovirus Types 1, 2 and 3 Titers
Time frame: One month after primary vaccination
Number of Subjects With Antibodies to Neisseria Meningitidis Serogroup C and Y Polysaccharide Capsule (Anti-PSC and Anti-PSY) Concentrations Equal to or Above the Cut-off Values
Time frame: One month after primary vaccination
Anti-PSC and Anti-PSY Antibody Concentrations
Time frame: One month after primary vaccination
Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values
Time frame: One month after the primary vaccination course
Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values
Time frame: Prior to the fourth dose vaccination and one month after fourth dose vaccination
Anti-PRP Antibody Concentrations
Time frame: One month after the primary vaccination course
Anti-PRP Antibody Concentrations
Time frame: Prior to the fourth dose vaccination and one month after fourth dose vaccination
Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values
Time frame: One month after the primary vaccination course
Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values
Time frame: Prior to the fourth dose vaccination and one month after fourth dose vaccination
hSBA-MenC and hSBA-MenY Antibody Titers
Time frame: One month after the primary vaccination course
hSBA-MenC and hSBA-MenY Antibody Titers
Time frame: Prior to the fourth dose vaccination and one month after fourth dose vaccination
Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values
Time frame: One month after the primary vaccination course
Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values
Time frame: Prior to the fourth dose vaccination and one month after fourth dose vaccination
Anti-PSC and Anti-PSY Antibodies Concentrations
Time frame: One month after the primary vaccination course
Anti-PSC and Anti-PSY Antibody Concentrations
Time frame: Prior to the fourth dose vaccination and one month after fourth dose vaccination
Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Value
Time frame: One month after the primary vaccination course
Anti-PRP Antibody Concentrations
Time frame: One month after the primary vaccination course and prior to the fourth dose vaccination
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values
Time frame: One month after the primary vaccination course
Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values
Time frame: Prior to the fourth dose vaccination and 42 days after fourth dose vaccination
Anti-PSC and Anti-PSY Antibody Concentrations
Time frame: Prior to the fourth dose vaccination and 42 days after fourth dose vaccination
Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above 0.15 Microgram Per Milliliter (µg/mL)
Time frame: Prior to the fourth dose vaccination and 42 days after fourth vaccination
Anti-PRP Antibody Concentrations
Time frame: Prior to the fourth vaccination and 42 days after fourth vaccination
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Concentrations Equal to or Above 1:4
Time frame: Prior to the fourth dose vaccination and 42 days after fourth vaccination
Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 200 Milli-international Units Per Millilitre (mIU/mL)
Time frame: 42 days after fourth vaccination
Anti-measles Antibody Concentrations
Time frame: 42 days after fourth vaccination
Number of Subjects With Anti-mumps Titer Equal to or Above the Cut-off Values
Time frame: 42 days after fourth vaccination
Anti-mumps Antibody Titers
Time frame: 42 days after fourth vaccination
Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 4 International Units Per Millilitre (IU/mL)
Time frame: 42 days after fourth vaccination
Anti-rubella Antibody Concentrations
Time frame: 42 days after fourth vaccination
Number of Subjects With Anti-varicella Titer Equal to or Above 1:40
Time frame: 42 days after fourth vaccination
Anti-varicella Antibody Titers
Time frame: 42 days after fourth vaccination
Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40
Time frame: Prior to the fourth dose vaccination and one month after the fourth dose vaccination
Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit
Time frame: In the 4-day (Day 0-3) follow-up period after primary vaccination course

Results and safety

Results posted to the registry on 6 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Menhibrix Group	3,136	2,888
ActHIB Group	1,044	961

Primary outcome: Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations

Time frame: One month after primary vaccination. Geometric mean (95% Confidence Interval). Unit: microgram per milliliter (µg/mL)

Measure	Menhibrix A Group n = 162	Menhibrix B Group n = 180	Menhibrix C Group n = 176	Menhibrix Group n = 518	ActHIB Group n = 171
Value	10.170 (8.855 to 11.681)	11.424 (9.710 to 13.441)	11.438 (9.503 to 13.768)	11.021 (10.027 to 12.114)	6.463 (5.288 to 7.900)

Menhibrix A Group vs Menhibrix B Group: GMC ratio: 1.12 (95% CI 0.89 to 1.42)
Menhibrix A Group vs Menhibrix C Group: GMC ratio: 1.12 (95% CI 0.89 to 1.42)
Menhibrix B Group vs Menhibrix C Group: GMC ratio: 1 (95% CI 0.8 to 1.26)

Population analysed: The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.

Primary outcome: Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers

Time frame: One month after primary vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Menhibrix A Group n = 158	Menhibrix B Group n = 168	Menhibrix C Group n = 165	Menhibrix Group n = 491	ActHIB Group n = 164
Value	910.0 (754.6 to 1097.3)	1118.0 (931.1 to 1342.5)	885.7 (712.4 to 1101.2)	967.6 (864.0 to 1083.5)	2.5 (2.2 to 2.9)

Menhibrix A Group vs Menhibrix B Group: GMT ratio: 1.23 (95% CI 0.93 to 1.62)
Menhibrix A Group vs Menhibrix C Group: GMT ratio: 0.97 (95% CI 0.74 to 1.29)
Menhibrix B Group vs Menhibrix C Group: GMT ratio: 0.79 (95% CI 0.6 to 1.04)

Primary outcome: Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers

Time frame: One month after primary vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Menhibrix A Group n = 150	Menhibrix B Group n = 168	Menhibrix C Group n = 163	Menhibrix Group n = 481	ActHIB Group n = 162
Value	178.9 (136.4 to 234.6)	288.1 (232.8 to 356.6)	249.6 (195.6 to 318.7)	236.6 (205.7 to 272.1)	2.2 (2.0 to 2.4)

Menhibrix A Group vs Menhibrix B Group: GMT ratio: 1.61 (95% CI 1.14 to 2.27)
Menhibrix A Group vs Menhibrix C Group: GMT ratio: 1.4 (95% CI 0.99 to 1.97)
Menhibrix B Group vs Menhibrix C Group: GMT ratio: 0.87 (95% CI 0.62 to 1.21)

Primary outcome: hSBA-MenC Antibody Titers

Time frame: Prior to the fourth dose vaccination and 42 days after the fourth dose. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Menhibrix Group n = 331	ActHIB Group n = 119
hSBA-MenC [post-dose 4]	2039.8 (1746.3 to 2382.6)	4.3 (3.2 to 5.8)
hSBA-MenC [pre-dose 4]	180.3 (155.6 to 208.8)	3.0 (2.4 to 3.7)

Menhibrix Group: GMT ratio: 12 (95% CI 10.4 to 13.8)
ActHIB Group: GMT ratio: 1.4 (95% CI 1.4 to 1.4)

Population analysed: The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.

59 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs: From Day 0 after Dose 1 through the day preceding the fourth dose; From the fourth dose phase through the end of the safety follow-up; AEs: within the 31-day (Day 0-30) post vaccination period; Solicited AEs: Duting the 4-day post vaccination period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Menhibrix Group	126 of 3,136 (4%)	3,034 of 3,136 (96.7%)	Not reported
ActHIB Group	50 of 1,044 (4.8%)	998 of 1,044 (95.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21806393Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90.
Background: PubMed 21624883Bryant KA, Marshall GS, Marchant CD, Pavia-Ruiz N, Nolan T, Rinderknecht S, Blatter M, Aris E, Lestrate P, Boutriau D, Friedland LR, Miller JM. Immunogenicity and safety of H influenzae type b-N meningitidis C/Y conjugate vaccine in infants. Pediatrics. 2011 Jun;127(6):e1375-85. doi: 10.1542/peds.2009-2992. Epub 2011 May 29.
Background: PubMed 22617844Bryant K, McVernon J, Marchant C, Nolan T, Marshall G, Richmond P, Marshall H, Nissen M, Lambert S, Aris E, Mesaros N, Miller J. Immunogenicity and safety of measles-mumps-rubella and varicella vaccines coadministered with a fourth dose of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine in toddlers: a pooled analysis of randomized trials. Hum Vaccin Immunother. 2012 Aug;8(8):1036-41. doi: 10.4161/hv.20357. Epub 2012 Aug 1.
BackgroundBryant KA et al. Immune response to measles, mumps, rubella (MMR) and varicella (V) vaccine coadministered with a fourth dose of Haemophilus influenzae type b - Neisseria meningitidis serogroups C and Y - tetanus toxoid conjugate (HibMenCY) vaccine in toddlers. Abstract presented at the Annual meeting of Pediatric Academic Societies (PAS). Vancouver, Canada, 1-4 May 2010.
Derived from this study: PubMed 22327493Rinderknecht S, Bryant K, Nolan T, Pavia-Ruz N, Doniz CA, Weber MA, Cohen C, Aris E, Mesaros N, Miller JM. The safety profile of Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY). Hum Vaccin Immunother. 2012 Mar;8(3):304-11. doi: 10.4161/hv.18752. Epub 2012 Feb 13.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Related trials for Haemophilus Influenzae Type b

Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Not yet recruitingPhase 3
Study Interchangeability Hep-B Vaccine Administered at Birth Dose
Vaccination Adverse Event, Immunogenicity, Vaccine
Active, not recruitingPhase 2/3
A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series
Diphtheria, Tetanus
Not yet recruitingPhase 3
Study of BK1803 in Healthy Infants
Pertussis, Diphtheria
Active, not recruitingPhase 1
Clinical Trial of Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine
Haemophilus Influenzae Type B Infection

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

93 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in United States, Australia, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations (time frame: One month after primary vaccination). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00289783, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2018.