Haemophilus Influenzae Type bPhase 3NCT01000974

Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants

A Phase 3 study testing GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108), ActHIB™ and Pentacel™ in people with Haemophilus Influenzae Type b, run by GlaxoSmithKline at 63 sites in United States.

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

The purpose of this study is to evaluate safety, to demonstrate lot-to-lot consistency of the vaccine, to address the relevant concomitant vaccine administrations and to provide a comparison between GSK Biologicals' Hib conjugate vaccine and the licensed monovalent Hib vaccine ActHIB as well as the licensed… Read more about this study

Who is it for?: Ages 6 to 12 weeksHealthy volunteers can take part
Conditions the study is for: Haemophilus Influenzae Type b
What is being tested?: GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108), ActHIB™ and Pentacel™
Type of treatment: Vaccines, Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4,003 participants
Where: 63 sitesUnited States
Study dates: 18 Jun 2010to 17 Jul 2013
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 to 12 weeks
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Subjects for whom the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR[s]) can and will comply with the requirements of the protocol (e.g., completion of the diary card, return for follow-up visits).
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 subject's parent/LAR.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Born after a gestation period of minimum 36 weeks.
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.

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 of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine and until 30 days after the booster dose.
Previous vaccination against Haemophilus influenzae type b, diphtheria, tetanus, pertussis, Pneumococcus, rotavirus and/or poliovirus; more than one previous dose of hepatitis B vaccine.
History of Haemophilus influenzae type b, diphtheria, tetanus, pertussis, pneumococcal, rotavirus, poliovirus, and hepatitis B diseases.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.

Show all 16Show 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. All vaccines can be administered to persons with a minor illness.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Concurrent participation in another clinical study, up to 30 days prior to study entry or 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).
Child in care.
History of intussusception.
History of uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception.
History of Severe Combined Immunodeficiency Disease.

Trial locations and contacts

63 sites in 1 country.

City, postcode or hospital

63 sites in 1 country

United States63 sites

GSK Investigational Site
Amarillo, Texas, 79124
GSK Investigational Site
Anaheim, California, 92804
GSK Investigational Site
Antioch, California, 94509
GSK Investigational Site
Bardstown, Kentucky, 40004
GSK Investigational Site
Benton, Arkansas, 72019
GSK Investigational Site
Boulder, Colorado, 80304
GSK Investigational Site
Bountiful, Utah, 84010
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Charleston, South Carolina, 29406
GSK Investigational Site
Cincinnati, Ohio, 45229
GSK Investigational Site
Cleveland, Ohio, 44121
GSK Investigational Site
Colorado Springs, Colorado, 80922
GSK Investigational Site
Daly City, California, 94015
GSK Investigational Site
Dayton, Ohio, 45406
GSK Investigational Site
Dothan, Alabama, 36305
GSK Investigational Site
Erie, Pennsylvania, 16505
GSK Investigational Site
Fall River, Massachusetts, 02721
GSK Investigational Site
Fargo, North Dakota, 58103
GSK Investigational Site
Fayetteville, Arkansas, 72703
GSK Investigational Site
Fort Worth, Texas, 76107
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Fremont, California, 94538
GSK Investigational Site
Fresno, California, 93726
GSK Investigational Site
Greenville, Pennsylvania, 16125
GSK Investigational Site
Hayward, California, 94545
GSK Investigational Site
Hermitage, Pennsylvania, 16148
GSK Investigational Site
Honolulu, Hawaii, 96819
GSK Investigational Site
Houston, Texas, 77055
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Jonesboro, Arkansas, 72401
GSK Investigational Site
Layton, Utah, 84041
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Louisville, Kentucky, 40291
GSK Investigational Site
Madison, Wisconsin, 53792
GSK Investigational Site
Marietta, Georgia, 30062
GSK Investigational Site
Marshfield, Wisconsin, 54449
GSK Investigational Site
Mineola, New York, 11501
GSK Investigational Site
Nampa, Idaho, 83686
GSK Investigational Site
Oakland, California, 94612
GSK Investigational Site
Omaha, Nebraska, 68131
GSK Investigational Site
Orange City, Florida, 32763
GSK Investigational Site
Redwood City, California, 94063
GSK Investigational Site
Roseville, California, 95661
GSK Investigational Site
Roy, Utah, 84067
GSK Investigational Site
Sacramento, California, 95815
GSK Investigational Site
Sacramento, California, 95823
GSK Investigational Site
Saint Paul, Minnesota, 55108
GSK Investigational Site
Salt Lake City, Utah, 84109
GSK Investigational Site
San Jose, California, 95119
GSK Investigational Site
Santa Clara, California, 95051
GSK Investigational Site
Santa Rosa, California, 95403
GSK Investigational Site
South Jordan, Utah, 84095
GSK Investigational Site
Stevensville, Michigan, 49127
GSK Investigational Site
Sugar Land, Texas, 77479
GSK Investigational Site
Syracuse, New York, 13210
GSK Investigational Site
Syracuse, Utah, 84075
GSK Investigational Site
Tulsa, Oklahoma, 74107
GSK Investigational Site
Utica, New York, 13502
GSK Investigational Site
Vallejo, California, 94589
GSK Investigational Site
Waipio, Hawaii, 96797
GSK Investigational Site
Walnut Creek, California, 94596
GSK Investigational Site
West Covina, California, 91790
GSK Investigational Site
Woodstock, Georgia, 30189

Other trials in United States

About this study

Official title: Phase III, Partially Double-blind Study to Evaluate Consistency and Immunogenicity of 3 Lots of GSK Biologicals' Hib Conjugate Vaccine 208108 Versus ActHIB and Pentacel at 2, 4, 6 and 15-18 Months of Age in Healthy Infants

Read the detailed description

This protocol posting has been updated following protocol amendment 3, dated 12 April 2011. The impacted section is: Eligibility Criteria (Exclusion criteria).

Conditions: Haemophilus Influenzae Type b
Being tested: GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108), ActHIB™, Pentacel™, Pediarix™, Prevnar 13™
Keywords: primary vaccination course, Haemophilus influenzae type b, infants, children, booster vaccination, immunogenicity, safety, Gram-negative bacterial infections, vaccines, conjugate
Medical subject headings: Haemophilus Infections, Gram-Negative Bacterial 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 vaccine (GSK 208108)Biological
Also called Hiberix®
Three doses of 3 different manufacturing lots in primary study at 2, 4 and 6 months of age as intramuscular injection and one dose as booster vaccination.
ActHIB™Biological
Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination
Pentacel™Biological
Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination
Pediarix™Biological
Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection
Prevnar 13™Biological
Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection
Rotarix™Biological
Two oral doses in primary epoch at 2 and 4 months of age
Engerix™-BBiological
Two or three doses in primary epoch at 2,( 4) and 6 months of age as intramuscular injection
Infanrix™Biological
One dose in the booster epoch at 15-18 months of age as intramuscular injection

Study groups in NCT01000974
Study group	Role	What they receive
Hiberix Group	Experimental	Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. Receives: Biological: GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108); Biological: Pediarix™; Biological: Prevnar 13™; Biological: Rotarix™; Biological: Infanrix™
ActHIB Group	Active comparator	Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. Receives: Biological: ActHIB™; Biological: Pediarix™; Biological: Prevnar 13™; Biological: Rotarix™; Biological: Infanrix™
Pentacel Group	Active comparator	Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age. Receives: Biological: Pentacel™; Biological: Prevnar 13™; Biological: Rotarix™; Biological: Engerix™-B

What is being measured

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

Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL
Non-inferiority of Hiberix to ActHIB, each co-administered with Pediarix, Prevnar13 and Rotarix following 3 primary doses in terms of immune response to PRP (Anti-PRP≥ 0.15 µ g/ml and ≥1.0 µg/mL).
Measured: At 1 month after last dose of primary vaccination
Number of Subjects With Anti-Protein-D (Anti-D) and Anti-Protein-T (Anti-T) Antibody Concentrations ≥ 0.1 International Units Per Milliliter (IU/mL)
Non-inferiority of Pediarix co-administered with Hiberix, Prevnar13 and Rotarix compared to Pediarix co-administered with ActHIB, Prevnar13 and Rotarix following 3 primary vaccine doses in terms of immune response to Diphtheria, Tetanus.
Measured: At 1 month after last dose of primary vaccination
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
Antibody concentrations were given as Geometric Mean Concentrations (GMCs) expressed in micrograms per milliliter (µg/mL).
Measured: At 1 month after last dose of primary vaccination
Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations
Antibody concentrations were given as geometric mean concentrations (GMCs) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter i.e. EL.U/mL.
Measured: At 1 month after last dose of primary vaccination
Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations
Antibody concentrations against S.pneumoniae were given as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).
Measured: At 1 month after last dose of primary vaccination
Number of Subjects With Seroresponse (95%) to Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA)
Seroresponse (95%) was defined as the number of subjects showing a concentration above a threshold that leads to 95% seroresponse in the ActHIB group.
Measured: At 1 month after last dose of primary vaccination
Number of Subjects With Anti-Polio 1,2,3 Antibody Titres Greater Than or Equal to Cut-off Value
The cut-off value was defined as a concentration ≥ 8 ED50 (ED50 is the concentration at which the protein exhibits 50% of its maximum activity).
The polio testing which started at the Biomnis laboratory was stopped because the polio virus micro-neutralization assays were found to be not in line with the quality standards defined in GSK Biologicals' SOPs. As a result, polio testing was restarted at the GSK laboratory and the results were uploaded into the clinical database.
Measured: At 1 month after last dose of primary vaccination
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 1.0 µg/mL
Non-inferiority of a booster dose of Hiberix co-administered with Infanrix in subjects 15-18 months of age who received 3 primary vaccine doses of Hiberix to a booster dose of ActHIB co-administered with Infanrix in subjects of 15-18 months of age who received 3 primary vaccine doses of ActHIB in terms of immune response to PRP
Measured: At 1 month after booster vaccination

Secondary outcomes (26)

Anti-protein-D (Anti-D) and Anti-protein-T (Anti-T) Antibody Concentrations
Antibody concentrations were given as geometric mean concentrations (GMCs) and expressed as International Units per milliliter (IU/mL).
Measured: At 1 month after last dose of primary vaccination
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any symptom regardless of intensity grade.
Measured: During a 4-day follow-up period (Days 0-3) following any vaccination
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, fever and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Any fever= Rectal temperature equal to or above (≥) 38 degrees Celsius (°C).
Measured: During a 4-day follow-up period (Days 0-3) following any vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs).
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: During the 31-day (Day 0-Day 30) follow-up period after primary vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: From Day 0 until 6 months following the last primary dose
Number of Subjects With AEs of Specific Interest (AESIs)
An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Measured: From Day 0 until 6 months following the last primary dose or the receipt of the booster vaccination, whichever comes first
Number of Subjects With Seroresponse (90%) to Anti-PT, Anti-PRN and Anti-FHA
Seroresponse (90%) was defined as the number of subjects showing a concentration above a threshold that leads to 90% seroresponse in the ActHIB group.
Measured: At 1 month after last dose of primary vaccination
Number of Subjects With Anti-PT, Anti-PRN and Anti-FHA Antibody Concentrations ≥ 5 EL.U/mL
Seroresponse was defined as the number of subjects showing a concentration above a threshold that leads to 90% seroresponse in the ActHIB group.
Measured: At 1 month after last dose of primary vaccination
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL
Evaluation of persistence of anti-PRP antibodies induced by three primary vaccine doses of Hiberix, and ActHIB, each co-administered with Pediarix, Prevnar 13 and Rotarix, or Pentacel co-administered with Engerix-B, Rotarix and Prevnar 13 prior to the booster dose of Hiberix, ActHIB or Pentacel at 15-18 months of age and evaluation of immunogenicity of a booster dose of Hiberix co-administered with Infanrix, ActHIB co-administered with Infanrix and Pentacel in terms of the percentage of subjects with anti-PRP concentrations ≥0.15 µg/mL, ≥1.0 µg/mL and GMCs one month after the booster dose.
Measured: Prior to the booster vaccination and 1 month after the booster vaccination
Anti-Hepatitis B (Anti-HBs) Antibody Concentrations
Antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressedas milli-international units per milliliter (mIU/mL).
Measured: At 1 month after last dose of primary vaccination
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL
Evaluation of immunogenicity of a 3-dose primary vaccination course of Prevnar 13 co-administered with Hiberix, Rotarix and Pediarix, of Prevnar 13 co-administered with ActHIB, Rotarix and Pediarix and of Prevnar 13 co-administered with Pentacel, Rotarix and Engerix-B in terms of S.pneumoniae GMCs and antibody concentrations ≥ 0.05µg/mL, ≥ 0.2 µg/mL, ≥ 1.0 µg/mL at one month after the last dose of primary vaccination.
Measured: At 1 month after the last dose of primary vaccination
Antibody Titers for Poliovirus Types 1, 2 and 3
Antibody titers were given as geometric mean titers(GMTs).
Measured: At 1 month after last dose of primary vaccination
Number of Subjects With Anti-HBs Antibody Concentrations Greater Than or Equal to Cut-off Values
The cut-off values were defined as a concentration≥ 3.3 mIU/mL (seropositivity) and ≥ 10 mIU/mL (seroprotection).
Measured: At 1 month after last dose of primary vaccination
Anti-polyribosylribitol Phosphate (PRP) Antibody Concentrations
Antibody concentrations were given as Geometric Mean Concentrations (GMCs) expressed in micrograms per milliliter (µg/mL).
Measured: Prior to the booster vaccination and 1 month after the booster vaccination
Anti-Hepatitis B (Anti-HBs) Antibody Concentrations ≥10.0 mIU/mL and ≥6.2 mIU/mL
Antibody concentrations were expressed as geometric mean concentrations (GMCs) and expressed as milli-international units per milliliter (mIU/mL).
Measured: Prior to the booster vaccination
Number of Subjects With Anti-HB Antibody Concentrations ≥10.0 mlU/mL and ≥6.2mLU/mL
The cut-off values were defined as a concentration≥ 6.2 mIU/mL (seropositivity) and ≥ 10 mIU/mL (seroprotection).
Measured: Prior to booster vaccination
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL
Evaluation of persistence of anti-PT, anti-FHA and anti-PRN antibodies induced by Pediarix or Pentacel and Engerix-B prior to the administration of a booster dose of Hib vaccine at 15-18 months of age and evaluation of immunogenicity of a booster dose of Infanrix co-administered with Hiberix, a booster dose of Infanrix co-administered with ActHIB and a booster dose of Pentacel with respect to anti-PT, anti-FHA and anti- PRN antibodies.
Measured: Prior to the booster vaccination and 1 month after the booster vaccination
Anti-poliovirus Types 1, 2, and 3 Antibody Titres and Titres ≥ 8
Antibody concentrations were tabulated as geometric mean titers (GMTs) and expressed as titers.
Measured: Prior to the booster vaccination
Number of Subjects With Anti-Polio-1,2,3 Antibody Titers ≥ 8
Anti-polio 1,2,3 antibody titers greater or equal to the cut off value were calculated.
Measured: Prior to booster vaccination
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively.
Evaluation of persistence of anti-D, anti-T antibodies induced by Pediarix or Pentacel and Engerix-B prior to the administration of a booster dose of Hib vaccine at 15-18 months of age and evaluation of immunogenicity of a booster dose of Infanrix co-administered with Hiberix, a booster dose of Infanrix co-administered with ActHIB and a booster dose of Pentacel with respect to anti-D and anti-T antibodies.
Measured: Prior to the booster vaccination and 1 month after the booster vaccination
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any symptom regardless of intensity grade.
Measured: Within 4 days (Days 0-3) following the booster dose
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, fever and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Any fever= Axillary temperature equal to or above (≥) 38 degrees Celsius (°C).
Measured: Within 4 days (Days 0-3) following the booster dose
Number of Subjects With AEs of Specific Interest (AESIs)
An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Measured: From booster dose until 6 months following receipt of the booster dose
Number of Subjects With Any Unsolicited Adverse Events (AEs).
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: Within 31 days (Day 0 to Day 30) following the booster dose
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: From the booster dose until 6 months following receipt of the booster dose
Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations
Antibody concentrations were given as geometric mean concentrations (GMCs) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter i.e. EL.U/mL.
Measured: pre-booster and one month after booster vaccination

Timeline

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

18 Jun 201017 Jul 2013

First posted23 Oct 2009 (estimated)
Study start18 Jun 2010
Primary completion18 Nov 2011
Study completion17 Jul 2013

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.
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: Double blind
Who is masked: Participant, Care provider
Enrolment: 4,003 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01000974
Sponsor's protocol ID: 112957
Status last verified: Jun 2018
First submitted: 22 Oct 2009
Last updated: 12 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

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 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase III, Partially Double-blind Study to Evaluate Consistency and Immunogenicity of 3 Lots of GSK Biologicals' Hib Conjugate Vaccine 208108 Versus ActHIB and Pentacel at 2, 4, 6 and 15-18 Months of Age in Healthy Infants
ClinicalTrials.gov ID: NCT01000974
Acronym / sponsor ID: 112957
Conditions: Haemophilus Influenzae Type b
Keywords: primary vaccination course, Haemophilus influenzae type b, infants, children, booster vaccination, immunogenicity, safety, Gram-negative bacterial infections, vaccines, conjugate
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 4,003 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 18 Jun 2010
Primary completion: 18 Nov 2011 (actual)
Study completion: 17 Jul 2013 (actual)
First posted: 23 Oct 2009 (estimated)
Results: Posted 19 Aug 2013

Clinical summary

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

Detailed description

This protocol posting has been updated following protocol amendment 3, dated 12 April 2011. The impacted section is: Eligibility Criteria (Exclusion criteria).

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 3

Arm	Type	Receives
Hiberix Group	Experimental	Biological: GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108), Biological: Pediarix™, Biological: Prevnar 13™, Biological: Rotarix™, Biological: Infanrix™Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
ActHIB Group	Active comparator	Biological: ActHIB™, Biological: Pediarix™, Biological: Prevnar 13™, Biological: Rotarix™, Biological: Infanrix™Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
Pentacel Group	Active comparator	Biological: Pentacel™, Biological: Prevnar 13™, Biological: Rotarix™, Biological: Engerix™-BSubjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.

Who may qualify

Ages: 6 to 12 weeks
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

Subjects for whom the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR[s]) can and will comply with the requirements of the protocol (e.g., completion of the diary card, return for follow-up visits).
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 subject's parent/LAR.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Born after a gestation period of minimum 36 weeks.

Key exclusion criteria (16 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 of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine and until 30 days after the booster dose.
Previous vaccination against Haemophilus influenzae type b, diphtheria, tetanus, pertussis, Pneumococcus, rotavirus and/or poliovirus; more than one previous dose of hepatitis B vaccine.
History of Haemophilus influenzae type b, diphtheria, tetanus, pertussis, pneumococcal, rotavirus, poliovirus, and hepatitis B diseases.

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 vaccine (GSK 208108)Also: Hiberix®Three doses of 3 different manufacturing lots in primary study at 2, 4 and 6 months of age as intramuscular injection and one dose as booster vaccination.	Biological	Hiberix Group
ActHIB™Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination	Biological	ActHIB Group
Pentacel™Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination	Biological	Pentacel Group
Pediarix™Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection	Biological	ActHIB Group, Hiberix Group
Prevnar 13™Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection	Biological	ActHIB Group, Hiberix Group, Pentacel Group
Rotarix™Two oral doses in primary epoch at 2 and 4 months of age	Biological	ActHIB Group, Hiberix Group, Pentacel Group
Engerix™-BTwo or three doses in primary epoch at 2,( 4) and 6 months of age as intramuscular injection	Biological	Pentacel Group
Infanrix™One dose in the booster epoch at 15-18 months of age as intramuscular injection	Biological	ActHIB Group, Hiberix Group

Primary outcome

Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL
Time frame: At 1 month after last dose of primary vaccination
Non-inferiority of Hiberix to ActHIB, each co-administered with Pediarix, Prevnar13 and Rotarix following 3 primary doses in terms of immune response to PRP (Anti-PRP≥ 0.15 µ g/ml and ≥1.0 µg/mL).
Number of Subjects With Anti-Protein-D (Anti-D) and Anti-Protein-T (Anti-T) Antibody Concentrations ≥ 0.1 International Units Per Milliliter (IU/mL)
Time frame: At 1 month after last dose of primary vaccination
Non-inferiority of Pediarix co-administered with Hiberix, Prevnar13 and Rotarix compared to Pediarix co-administered with ActHIB, Prevnar13 and Rotarix following 3 primary vaccine doses in terms of immune response to Diphtheria, Tetanus.
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
Time frame: At 1 month after last dose of primary vaccination
Antibody concentrations were given as Geometric Mean Concentrations (GMCs) expressed in micrograms per milliliter (µg/mL).
Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations
Time frame: At 1 month after last dose of primary vaccination
Antibody concentrations were given as geometric mean concentrations (GMCs) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter i.e. EL.U/mL.
Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations
Time frame: At 1 month after last dose of primary vaccination
Antibody concentrations against S.pneumoniae were given as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).
Number of Subjects With Seroresponse (95%) to Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA)
Time frame: At 1 month after last dose of primary vaccination
Seroresponse (95%) was defined as the number of subjects showing a concentration above a threshold that leads to 95% seroresponse in the ActHIB group.
Number of Subjects With Anti-Polio 1,2,3 Antibody Titres Greater Than or Equal to Cut-off Value
Time frame: At 1 month after last dose of primary vaccination
The cut-off value was defined as a concentration ≥ 8 ED50 (ED50 is the concentration at which the protein exhibits 50% of its maximum activity). The polio testing which started at the Biomnis laboratory was stopped because the polio virus micro-neutralization assays were found to be not in line with the quality standards defined in GSK Biologicals' SOPs. As a result, polio testing was restarted at the GSK laboratory and the results were uploaded into the clinical database.
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 1.0 µg/mL
Time frame: At 1 month after booster vaccination
Non-inferiority of a booster dose of Hiberix co-administered with Infanrix in subjects 15-18 months of age who received 3 primary vaccine doses of Hiberix to a booster dose of ActHIB co-administered with Infanrix in subjects of 15-18 months of age who received 3 primary vaccine doses of ActHIB in terms of immune response to PRP

26 secondary outcomes

Anti-protein-D (Anti-D) and Anti-protein-T (Anti-T) Antibody Concentrations
Time frame: At 1 month after last dose of primary vaccination
Number of Subjects With Any Solicited Local Symptoms
Time frame: During a 4-day follow-up period (Days 0-3) following any vaccination
Number of Subjects With Any Solicited General Symptoms
Time frame: During a 4-day follow-up period (Days 0-3) following any vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs).
Time frame: During the 31-day (Day 0-Day 30) follow-up period after primary vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From Day 0 until 6 months following the last primary dose
Number of Subjects With AEs of Specific Interest (AESIs)
Time frame: From Day 0 until 6 months following the last primary dose or the receipt of the booster vaccination, whichever comes first
Number of Subjects With Seroresponse (90%) to Anti-PT, Anti-PRN and Anti-FHA
Time frame: At 1 month after last dose of primary vaccination
Number of Subjects With Anti-PT, Anti-PRN and Anti-FHA Antibody Concentrations ≥ 5 EL.U/mL
Time frame: At 1 month after last dose of primary vaccination
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL
Time frame: Prior to the booster vaccination and 1 month after the booster vaccination
Anti-Hepatitis B (Anti-HBs) Antibody Concentrations
Time frame: At 1 month after last dose of primary vaccination
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL
Time frame: At 1 month after the last dose of primary vaccination
Antibody Titers for Poliovirus Types 1, 2 and 3
Time frame: At 1 month after last dose of primary vaccination
Number of Subjects With Anti-HBs Antibody Concentrations Greater Than or Equal to Cut-off Values
Time frame: At 1 month after last dose of primary vaccination
Anti-polyribosylribitol Phosphate (PRP) Antibody Concentrations
Time frame: Prior to the booster vaccination and 1 month after the booster vaccination
Anti-Hepatitis B (Anti-HBs) Antibody Concentrations ≥10.0 mIU/mL and ≥6.2 mIU/mL
Time frame: Prior to the booster vaccination
Number of Subjects With Anti-HB Antibody Concentrations ≥10.0 mlU/mL and ≥6.2mLU/mL
Time frame: Prior to booster vaccination
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL
Time frame: Prior to the booster vaccination and 1 month after the booster vaccination
Anti-poliovirus Types 1, 2, and 3 Antibody Titres and Titres ≥ 8
Time frame: Prior to the booster vaccination
Number of Subjects With Anti-Polio-1,2,3 Antibody Titers ≥ 8
Time frame: Prior to booster vaccination
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively.
Time frame: Prior to the booster vaccination and 1 month after the booster vaccination
Number of Subjects With Any Solicited Local Symptoms
Time frame: Within 4 days (Days 0-3) following the booster dose
Number of Subjects With Any Solicited General Symptoms
Time frame: Within 4 days (Days 0-3) following the booster dose
Number of Subjects With AEs of Specific Interest (AESIs)
Time frame: From booster dose until 6 months following receipt of the booster dose
Number of Subjects With Any Unsolicited Adverse Events (AEs).
Time frame: Within 31 days (Day 0 to Day 30) following the booster dose
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From the booster dose until 6 months following receipt of the booster dose
Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations
Time frame: pre-booster and one month after booster vaccination

Results and safety

Results posted to the registry on 19 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hiberix Group	2,963	2,625
ActHIB Group	520	470
Pentacel Group	520	457

Primary outcome: Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL

Time frame: At 1 month after last dose of primary vaccination. Number. Unit: Subjects

Measure	Hiberix Group n = 1590	ActHIB Group n = 274	Pentacel Group n = 253
Anti-PRP ≥ 0.15 µg/mL	1536	265	234
Anti-PRP ≥ 1.0 µg/mL	1291	246	198

Hiberix Group vs ActHIB Group: difference in percentage: -8.59 (95% CI -12.28 to -4.07), Non-inferiority analysis
Hiberix Group vs ActHIB Group: Difference in percentage: -0.11 (95% CI -1.98 to 2.82), Non-inferiority analysis

Population analysed: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and assay results available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.

Primary outcome: Number of Subjects With Anti-Protein-D (Anti-D) and Anti-Protein-T (Anti-T) Antibody Concentrations ≥ 0.1 International Units Per Milliliter (IU/mL)

Time frame: At 1 month after last dose of primary vaccination. Number. Unit: Subjects

Measure	Hiberix Group n = 393	ActHIB Group n = 274	Pentacel Group n = 250
Anti-D	393	273	249
Anti-T	393	274	249

Hiberix Group vs ActHIB Group: Difference in percentage: 0 (95% CI -1.26 to 1.81), Non-inferiority analysis
Hiberix Group vs ActHIB Group: Difference in percentage: 0 (95% CI -1.26 to 1.8), Non-inferiority analysis

Population analysed: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.

Primary outcome: Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations

Time frame: At 1 month after last dose of primary vaccination. Geometric mean (95% Confidence Interval). Unit: µg/mL

Measure	Hiberix Group n = 1590	ActHIB Group n = 274	Pentacel Group n = 253
Value	5.193 (4.765 to 5.658)	6.743 (5.593 to 8.129)	3.640 (2.891 to 4.583)

Population analysed: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.

Primary outcome: Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations

Time frame: At 1 month after last dose of primary vaccination. Geometric mean (95% Confidence Interval). Unit: EL.U/mL

Measure	Hiberix Group n = 792	ActHIB Group n = 275	Pentacel Group n = 251
Anti-PT	73.2 (69.8 to 76.6)	71.9 (66.6 to 77.6)	41.9 (38.4 to 45.8)
Anti-PRN	111.6 (104.5 to 119.2)	93.5 (83.7 to 104.4)	51.9 (45.4 to 59.3)
Anti-FHA	321.8 (307.0 to 337.3)	295.8 (276.0 to 317.0)	174.8 (160.0 to 191.0)

Hiberix Group vs ActHIB Group: GMC ratio: 1.017 (97.5% CI 0.918 to 1.127), Non-inferiority analysis
Hiberix Group vs ActHIB Group: GMC ratio: 1.088 (97.5% CI 0.983 to 1.204), Non-inferiority analysis
Hiberix Group vs ActHIB Group: GMC ratio: 1.193 (97.5% CI 1.03 to 1.382), Non-inferiority analysis

Population analysed: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.

26 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events
Hiberix Group	120 of 2,963 (4%)	2,783 of 2,963 (93.9%)
ActHIB Group	24 of 520 (4.6%)	495 of 520 (95.2%)
Pentacel Group	21 of 520 (4%)	488 of 520 (93.8%)

Limitations and caveats (from the sponsor): Anti-HBs antibody concentration cut off defining seropositivity was based on 6.2 mIU/mL instead of 3.3 mIU/mL for the pre-booster vaccination phase as tested by the commercial assay Centaur

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
IPD for this study will be made available via the Clinical Study Data Request site.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request 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

63 sites in 1 country: 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 6 inclusion and 16 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 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States. 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 19 Aug 2013). 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?

Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL (time frame: At 1 month after last dose of primary vaccination). The study lists 8 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 NCT01000974.

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 12 Jul 2018.