Haemophilus Influenzae Type bPhase 2NCT00129129
Comparison of GSKBiologicals' Hib-MenCY-TT Vaccine vs Licensed Hib Conjugate or Meningococcal Vaccine
A Phase 2 study testing GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine, ActHIB and Pediarix in people with Haemophilus Influenzae Type b and Neisseria Meningitidis, run by GlaxoSmithKline at 27 sites in United States.
Trial summary
This study is evaluating the safety and immunogenicity of GSK Biologicals' Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, each administered at 2, 4, and 6 months of age, and compared to licensed meningococcal serogroups A, C, Y, and W-135 polysaccharide vaccine administered… Read more about this study
- 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 influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine, ActHIB and Pediarix
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 756 participants
- Where
- 27 sitesUnited States
- Study dates
- 1 Aug 2004to 29 Mar 2006
- Phase
- Phase 2
- 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
- For Groups A and B
- Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
- Healthy 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.
- Free of obvious health problems as established by medical history and clinical examination before entering the study.
- Born after a gestation period between 36 and 42 weeks.
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- 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.
- For Group C
- Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
- Healthy male or female between, and including, 3 and 5 years of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering the study.
Who cannot join
- -For Groups A and B
- 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 within six months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s).
- Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliovirus, and/or Streptococcus pneumoniae; more than one previous dose of hepatitis B vaccine.
- History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, poliovirus, and/or Streptococcus pneumoniae disease.
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- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), 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.
- For Group C
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the 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 within six months prior to the vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the dose of study vaccine.
- Previous vaccination against Neisseria meningitidis.
- History of Neisseria meningitidis disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including dry natural latex rubber
- Major congenital defects or serious chronic illness.
- Acute disease at time of enrollment.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding vaccination or planned administration during the study period.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
GSK Investigational Site
Bardstown, Kentucky, 40004
GSK Investigational Site
Beaver Falls, Pennsylvania, 15010
GSK Investigational Site
Boardman, Ohio, 44512
GSK Investigational Site
Bossier City, Louisiana, 71111
GSK Investigational Site
Boston, Massachusetts, 02115
GSK Investigational Site
Boston, Massachusetts, 02118
GSK Investigational Site
Centennial, Colorado, 80112
GSK Investigational Site
Des Moines, Iowa, 50266
GSK Investigational Site
Erie, Pennsylvania, 16505
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Greenville, Pennsylvania, 16125
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Louisville, Kentucky, 40202
GSK Investigational Site
Louisville, Kentucky, 40272
GSK Investigational Site
Marietta, Georgia, 30062
GSK Investigational Site
New Bedford, Massachusetts, 02740
GSK Investigational Site
Norristown, Pennsylvania, 19401
GSK Investigational Site
Norwich, Connecticut, 06360
GSK Investigational Site
Pittsburgh, Pennsylvania, 15217
GSK Investigational Site
Pittsburgh, Pennsylvania, 15227
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
GSK Investigational Site
Rochester, New York, 14620
GSK Investigational Site
Rydal, Pennsylvania, 19046
GSK Investigational Site
The Bronx, New York, 10467
GSK Investigational Site
University Heights, Ohio, 44118
GSK Investigational Site
Warwick, Rhode Island, 02886
About this study
Official title: Evaluate Immuno and Safety of GSKBiologicals' HibMenCYTT vs Licensed Hib Conjugate Vaccine, Each Coadministered With Pediarix® and Prevnar®, in Healthy Infants. An Exploratory Control Group Will Receive Licensed Menomune® at 3 to 5 Years
This study is evaluating the safety and immunogenicity of GSK Biologicals' Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, each administered at 2, 4, and 6 months of age, and compared to licensed meningococcal serogroups A, C, Y, and W-135 polysaccharide vaccine administered at 3 to 5 years of age.
The safety and immunogenicity of a booster dose of Hib-MenCY-TT vaccine will be compared to a booster dose of licensed Hib conjugate vaccine, each administered at 12 to 15 months of age. The group primed with the Hib conjugate vaccine will re-randomized at 12-15 months of age to receive a booster dose of Hib-MenCY-TT or a booster dose of the Hib conjugate vaccine.
Read the detailed description
The non-inferiority of the immunogenicity, safety, and antibody persistence of Hib-MenCY-TT vaccine will be compared to ActHIB®, a monovalent Hib conjugate vaccine licensed in the US.
All subjects will be vaccinated at 2, 4, 6, and 12 to 15 months. The immunogenicity of the MenC and MenY antigens will be summarized.
MenC and MenY immunogenicity will be compared to Menomune® (a quadrivalent meningococcal A, C, Y, and W-135 plain polysaccharide vaccine licensed in the US) administered to children 3 to 5 years of age.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
- Being tested
- GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine, ActHIB, Pediarix, Prevnar, Menomune
- Keywords
- Immunogenicity, Primary & booster vaccination, Infants, Meningococcal vaccine, Safety, Children, Hib disease, Meningococcal disease
- 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 influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccineBiological
Primary phase: 3 IM doses Booster phase: 1 IM dose
ActHIBBiological
Primary phase: 3 IM doses Booster phase: 1 IM dose
PediarixBiological
Primary phase: 3 IM doses
PrevnarBiological
Primary phase: 3 IM doses Booster phase: 1 IM dose
MenomuneBiological
Primary phase: 1 SC dose
| Study group | Role | What they receive |
|---|---|---|
| MenHibrix Group | Experimental | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccinationDuring Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of Menhibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of Menhibrix™ during the Primary Phase received one dose of Menhibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, Menhibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, Menhibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh. Receives: Biological: GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine; Biological: Pediarix; Biological: Prevnar |
| ActHIB Group | Active comparator | During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either Menhibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively. Receives: Biological: ActHIB; Biological: Pediarix; Biological: Prevnar |
| Menomune Group | Active comparator | Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region. Receives: Biological: Pediarix; Biological: Prevnar; Biological: Menomune |
| ActHIB/Menhibrix Group | Experimental | Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of Menhibrix™ and a concomitant fourth dose of Prevnar™. Menhibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively. Receives: Biological: GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine; Biological: ActHIB; Biological: Pediarix; Biological: Prevnar |
| ActHIB/ActHIB Group | Experimental | Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively. Receives: Biological: ActHIB; Biological: Pediarix; Biological: Prevnar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value.
The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Measured: One month after the 3-dose primary vaccination course (at Month 5)
Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Measured: One month after the 3-dose primary vaccination course (at Month 5)
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Measured: One month after the 3-dose primary vaccination course (at Month 5)
Number of Subjects Reporting Any Grade 3 Symptoms
"Symptoms" were defined as solicited local and general symptoms and unsolicited adverse events (AEs). A "Grade 3" symptom was defined as any symptom that prevented normal everyday activity. "Any" was defined as an occurrence of any specified symptom regardless of intensity grade. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Measured: During the 4-day follow-up period after each primary vaccine dose
Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value
The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB/ActHIB groups .
Measured: One month after the fourth dose (at Month 11-14)
Secondary outcomes (70)
Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values
rSBA-MenC antibody cut-off values for this outcome were 1:8 and 1:128.
Measured: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers
Titers are presented as geometric mean titers (GMTs).
Measured: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values
rSBA-MenY antibody cut-off values for this outcome measure were 1:8 and 1:128.
Measured: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers
Titers are presented as geometric mean titers (GMTs).
Measured: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4
A composite outcome variable was formulated as follows for this immunogenicity analysis outcome: hSBA-Men titers ≥ 1:4 for subjects with post-vaccination rSBA-Men antibody titers ≥ 1:8 and lower than (<) 1:128.
Measured: One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)
Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4
A composite outcome variable was formulated as follows for this immunogenicity analysis outcome: hSBA-Men titers ≥ 1:4 for subjects with post-vaccination rSBA-Men antibody titers ≥ 1:8 and lower than (<) 1:128.
Measured: One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values
Anti-PSC antibody cut-off values for this outcome were 0.3 µg/mL and 2.0 µg/mL.
Measured: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
Anti-polysaccharide C (Anti-PSC) Antibody Concentrations
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).
Measured: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values
Anti-PSY antibody cut-off values for this outcome were 0.3 µg/mL and 2.0 µg/mL.
Measured: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)
Measured: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
Number of Subjects Reporting Medically Attended Visits
A medically attended visit was defined as an hospitalization, an emergency room visit or a visit to or from medical personnel. This Outcome Measure only concerns subjects in the Menomune Group.
Measured: During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0
Number of Subjects Reporting Rash
An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae. This Outcome Measure only concerns subjects in the Menomune Group.
Measured: During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0
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 subject . This Outcome Measure only concerns subjects in the Menomune Group.
Measured: During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0
Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values
Anti-PRP antibody cut-off values for this outcome were 0.15 µg/mL and 1.0 µg/mL. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Measured: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Anti-PRP Antibody Concentrations
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Measured: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off
The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.05 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Measured: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off
The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.2 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups
Measured: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off
The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.5 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Measured: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL)
The anti-diphtheria and anti-tetanus antibody cut-off value for this outcome was ≥ 0.1 IU/mL. This Outcome Measure only concerns the MenHibrix and ActHIB groups.
Measured: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Anti-diphtheria and Anti-tetanus Antibody Concentrations
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as international units per milliliter (IU/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Measured: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Number of Subjects With Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentration ≥ 10.0 Milli-international Units Per Milliliter (mIU/mL)
This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Measured: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentrations
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as milli-international units per milliliter (mIU/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Measured: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL
This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Measured: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Anti PT, Anti-FHA and Anti-PRN Antibody Concentrations
Concentrations of antibodies are presented as GMCs expressed as EL.U/mL. Results for one month after the 3-dose primary vaccination course (at Month 5) are presented under the Primary Outcome Measures section. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Measured: Prior to the primary vaccination course (at Day 0)
Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8
This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Measured: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Titers are presented as geometric mean titers (GMTs). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Measured: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Number of Subjects With Vaccine Response to PT, FHA and PRN
Vaccine response to PT/FHA/PRN was defined as, for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month post-primary vaccination course, and, for initially seropositive subjects, antibody concentration one month post-primary vaccination course ≥ 1-fold the pre-vaccination antibody concentration. A seronegative/seronegative subject was defined as a subject with antibody concentration </≥ 5 EL.U/mL for anti-PT/FHA/PRN prior to vaccination. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Measured: One month after the 3-dose primary vaccination course (at Month 5)
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms
Solicited local symptoms were pain, redness and swelling at injection site. "Any" = any report of the specified symptom irrespective of intensity grade; "Grade 2 pain" = cried/protested on touch; "Grade 3 pain" = cried when limb was moved/spontaneously painful; "Grade 2 or 3" redness/swelling = redness/swelling larger than (>) 10 millimeters (mm); "Grade 3" redness/swelling = redness/swelling > 30 mm. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Measured: Within 4 days (Day 0-3) after the 3-dose primary vaccination
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms
Solicited local symptoms were pain, redness and swelling at injection site. "Any" = any report of the specified symptom irrespective of intensity grade; "Grade 2 pain" = cried/protested on touch; "Grade 3 pain" = cried when limb was moved/spontaneously painful; "Grade 2 or 3" redness/swelling = redness/swelling larger than (>) 10 millimeters (mm); "Grade 3" redness/swelling = redness/swelling > 30 mm. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Measured: Within 8 days (Day 0-7) after the 3-dose primary vaccination
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms
Solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. "Any" = any report of the specified symptom irrespective of intensity grade and relationship to vaccination. "Grade 2" for Drowsiness, Irritability/Fussiness and Loss of appetite = symptom that interfered with normal activity; "Grade 3" for Drowsiness and Irritability/Fussiness = symptom that prevented normal activity; "Grade 3" Loss of appetite = not eating at all. Fever = rectal temperature ≥ 38.0 degrees Celsius (°C); "Grade 2 or 3" fever = rectal temperature higher than (>) 39°C; "Grade 3" fever = rectal temperature > 40°C. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Measured: Within 4 days (Day 0-3) after the 3-dose primary vaccination
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms
Solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. "Any" = any report of the specified symptom irrespective of intensity grade and relationship to vaccination. "Grade 2" for Drowsiness, Irritability/Fussiness and Loss of appetite = symptom that interfered with normal activity; "Grade 3" for Drowsiness and Irritability/Fussiness = symptom that prevented normal activity; "Grade 3" Loss of appetite = not eating at all. Fever = rectal temperature ≥ 38.0 degrees Celsius (°C); "Grade 2 or 3" fever = rectal temperature higher than (>) 39°C; "Grade 3" fever = rectal temperature > 40°C. This Outcome Measure only concerns the MenHibrix and ActHIB groups
Measured: Within 8 days (Day 0-7) after the 3-dose primary vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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: From Dose 1 (at Day 0) through Day 30 following the last vaccine dose administered (Day 30 post Month 4 vaccination for MenHibrix and ActHIB groups, Day 30 post Month 1 for Menomune Group).
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: During the entire Primary Phase of the study, from Day 0 up to the end of Primary Phase safety follow-up period (6 months after the last 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. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Measured: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.
Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Measured: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine
Number of Subjects Reporting Rash
An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Measured: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.
Number of Subjects Reporting Emergency Room (ER) Visits or Visits to Physicians' Office, Related or Not to Common Illnesses
Emergency room (ER) visits or physicians office visits assessed were those unrelated to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis. This Outcome Measure only concerns the MenHibrix and ActHIB groups.
Measured: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.
Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y)
Fourth dose responses to rSBA-MenC and rSBA-MenY were defined as follows (Definition 1):
- Initially seronegative subjects (pre-fourth dose antibody titer below cut-off: < 1:8) should have an antibody titer at least four-fold higher than the cut-off, one month after fourth dose (post-fourth dose antibody titer ≥1:32),
- Initially seropositive subjects (pre-fourth dose antibody titer above cut-off: ≥1:8) should have an antibody titer at least four-fold higher than the pre-fourth dose antibody titer, one month after fourth dose.
Measured: One month post fourth dose vaccination (at Month 11-14)
Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y)
Fourth dose responses to rSBA-MenC and rSBA-MenY were also assessed using a second definition (Definition 2):
- Post-fourth dose rSBA antibody titers ≥1:32 in subjects seronegative at the pre-fourth dose time point (rSBA antibody titers < 1:8),
- At least (i.e., greater than or equal to) a 4-fold rise in rSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:8 but < 1:128,
- At least (i.e., greater than or equal to) a 2-fold rise in rSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:128.
Measured: One month post fourth dose vaccination (at Month 11-14)
Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y)
Fourth dose responses to hSBA-MenC and hSBA-MenY were defined as follows (Definition 1):
- Initially seronegative subjects (pre-fourth dose antibody titer below cut-off: < 1:8) should have an antibody titer at least four-fold higher than the cut-off, one month after the fourth dose (post-fourth dose antibody titer ≥1:16),
- Initially seropositive subjects (pre-fourth dose antibody titer above cut-off: ≥1:8) should have an antibody titer at least four-fold higher than the pre-fourth dose antibody titer, one month after the fourth dose.
Measured: One month post fourth dose vaccination (at Month 11-14)
Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y)
Fourth dose responses to hSBA-MenC and hSBA-MenY were also assessed using a second definition (Definition 2):
- Post-fourth dose hSBA antibody titers ≥1:16 in subjects seronegative at the pre-fourth dose time point (hSBA antibody titers < 1:8),
- At least (i.e., greater than or equal to) a 4-fold rise in hSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:4 but < 1: 8,
- At least (i.e., greater than or equal to) a 2-fold rise in hSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:8.
Measured: One month post fourth dose vaccination (at Month 11-14)
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL)
Streptococcus pneumoniae antibody cut-off values assessed was ≥0.05 µg/mL for the 7 serotypes in Prevnar vaccine.
Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F.
Measured: One month after fourth dose vaccination (at Month 11-14)
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL)
Streptococcus pneumoniae antibody cut-off values assessed was ≥0.2 µg/mL for the 7 serotypes in Prevnar vaccine.
Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F.
Measured: One month after fourth dose vaccination (at Month 11-14)
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL)
Streptococcus pneumoniae antibody cut-off values assessed was ≥0.5 µg/mL for the 7 serotypes in Prevnar vaccine.
Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F.
Measured: One month after fourth dose vaccination (at Month 11-14)
Concentration of Antibodies Against Streptococcus Pneumonia Serotypes
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).
Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F.
Measured: One month post fourth dose vaccination (at Month 11-14)
Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values
Anti-PRP antibody cut-off values assessed were ≥0.15 µg/mL and ≥1.0 µg/mL.
Measured: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Anti-PRP Antibody Concentrations
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)
Measured: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values
rSBA-MenC antibody cut-off values assessed were ≥1:8 and ≥1:128
Measured: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
rSBA-MenC Antibody Titers
Titers are presented as geometric mean titers (GMTs).
Measured: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values
rSBA-MenY antibody cut-off values assesse were ≥1:8 and ≥1:128.
Measured: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
rSBA-MenY Antibody Titers
Titers are presented as geometric mean titers (GMTs).
Measured: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values
hSBA-MenC antibody cut-off values assessed were ≥1:4 and ≥1:8.
Measured: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
hSBA-MenC Antibody Titers
Titers are presented as geometric mean titers (GMTs).
Measured: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values
hSBA-MenY antibody cut-off values assessed were ≥1:4 and ≥1:8.
Measured: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
hSBA-MenY Antibody Titers
Titers are presented as geometric mean titers (GMTs).
Measured: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values
Anti-PSC antibody cut-off values assessed were ≥0.3 µg/mL and ≥2.0 µg/mL.
Measured: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Anti-PSC Antibody Concentrations
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).
Measured: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values
Anti-PSY antibody cut-off values assessed were ≥0.3 µg/mL and ≥2.0 µg/mL.
Measured: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Anti-PSY Antibody Concentrations
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)
Measured: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Number of Subjects With Anti-tetanus Antibody Concentration Equal to or Above 0.1 International Units Per Milliliter (IU/mL)
Measured: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Anti-tetanus Antibody Concentrations
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as international units per milliliter (IU/mL).
Measured: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms
Solicited symptoms assessed were pain, redness, swelling at the injection site and increase in limb circumference. "Any"= any report of the specified symptom irrespective of intensity grade; "Grade 2 pain" = cried/protested on touch; "Grade 3 pain" = cried when limb was moved/spontaneously painful; "Grade 2 or 3" redness/swelling = redness/swelling >10 millimeters (mm); "Grade 3" redness/swelling = redness/swelling >30 mm; "Grade 2" limb circumference (LC) = LC >20 mm; "Grade 3" LC = LC >40 mm
Measured: Within 4 days (Day 0-3) after fourth dose vaccination
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms
Solicited symptoms assessed were pain, redness, swelling at the injection site and increase in limb circumference. "Any"= any report of the specified symptom irrespective of intensity grade; "Grade 2 pain" = cried/protested on touch; "Grade 3 pain" = cried when limb was moved/spontaneously painful; "Grade 2 or 3" redness/swelling = redness/swelling >10 millimeters (mm); "Grade 3" redness/swelling = redness/swelling >30 mm; "Grade 2" limb circumference (LC) = LC >20 mm; "Grade 3" LC = LC >40 mm
Measured: Within 8 days (Day 0-7) after fourth dose vaccination
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms
Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness, loss of appetite. "Any"= any report of the specified symptom irrespective of intensity and relationship to vaccination. "Grade 2" for Drowsiness, Irritability/Fussiness \& Loss of appetite = interfered with normal activity; "Grade 3" for Drowsiness, Irritability/Fussiness = prevented normal activity; "Grade 3" Loss of appetite = not eating at all; Fever = rectal temperature (T) ≥38.0 degrees Celsius (°C); "Grade 2 or 3" for fever = T >39.0°C; "Grade 3" for fever = T >40.0°C
Measured: Within 4 days (Day 0-3) after fourth dose vaccination
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms
Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness, loss of appetite. "Any"= any report of the specified symptom irrespective of intensity and relationship to vaccination. "Grade 2" for Drowsiness, Irritability/Fussiness \& Loss of appetite = interfered with normal activity; "Grade 3" for Drowsiness, Irritability/Fussiness = prevented normal activity; "Grade 3" Loss of appetite = not eating at all; Fever = rectal temperature (T) ≥38.0 degrees Celsius (°C); "Grade 2 or 3" for fever = T >39.0°C; "Grade 3" for fever = T >40.0°C
Measured: Within 8 days (Day 0-7) after fourth dose vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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: During the 31-day follow-up period following the fourth dose
Number of Subjects Reporting New Onset of Chronic Illness(es)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Measured: From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up
Number of Subjects Reporting Rash
An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae.
Measured: From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up
Number of Subjects Reporting Emergency Room (ER) Visits or Physicians Office Visits Related or Not to Common Illnesses
Emergency room (ER) visits or physicians office visits assessed were those unrelated to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis. This Outcome Measure only concerns the MenHibrix and ActHIB groups.
Measured: From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up
Number of Subjects Reporting Large Swelling Reactions of the Injected Limb(s)
Large injection site reactions were defined as either swelling with a diameter of > 30 mm or a > 30 mm increase in the circumference of the mid-thigh when compared to the baseline (pre-vaccination) measurement, or any diffuse swelling that interfered with or prevented everyday activities (for example, active playing, eating, sleeping).
Measured: Within 4 days (Day 0-3) and within 8 days (Day 0-7) following the fourth dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2005 (estimated)
- Study start1 Aug 2004
- Primary completion15 Sep 2005
- Study completion29 Mar 2006
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 (4)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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 756 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129129
- Sponsor's protocol ID
- 101858
- Other IDs
- 102015
- Status last verified
- Sep 2016
- First submitted
- 10 Aug 2005
- 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 21806393Marchant CD, Miller JM, Marshall GS, Blatter M, Aris E, Friedland LR, Boutriau D; HibMenCY-TT 005 Study Group. Randomized trial to assess immunogenicity and safety of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine in infants. Pediatr Infect Dis J. 2010 Jan;29(1):48-52. doi: 10.1097/INF.0b013e3181c3ce88.
PubMed 20035207Marshall GS, Marchant CD, Blatter M, Aris E, Boutriau D, Poolman JT, Friedland LR, Miller JM. Immune response and one-year antibody persistence after a fourth dose of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY) at 12 to 15 months of age. Pediatr Infect Dis J. 2010 May;29(5):469-71. doi: 10.1097/INF.0b013e3181cdd379.
PubMed 20072077Marshall GS, Marchant CD, Blatter M, Friedland LR, Aris E, Miller JM. Co-administration of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine does not interfere with the immune response to antigens contained in infant vaccines routinely used in the United States. Hum Vaccin. 2011 Feb;7(2):258-64. doi: 10.4161/hv.7.2.14170. Epub 2011 Feb 1.
PubMed 21307655
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
- Evaluate Immuno and Safety of GSKBiologicals' HibMenCYTT vs Licensed Hib Conjugate Vaccine, Each Coadministered With Pediarix® and Prevnar®, in Healthy Infants. An Exploratory Control Group Will Receive Licensed Menomune® at 3 to 5 Years
- ClinicalTrials.gov ID
- NCT00129129
- Acronym / sponsor ID
- 101858
- Keywords
- Immunogenicity, Primary & booster vaccination, Infants, Meningococcal vaccine, Safety, Children, Hib disease, Meningococcal disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 756 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2004
- Primary completion
- 15 Sep 2005 (actual)
- Study completion
- 29 Mar 2006 (actual)
- First posted
- 11 Aug 2005 (estimated)
- Results
- Posted 30 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is evaluating the safety and immunogenicity of GSK Biologicals' Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, each administered at 2, 4, and 6 months of age, and compared to licensed meningococcal serogroups A, C, Y, and W-135 polysaccharide vaccine administered at 3 to 5 years of age.
The safety and immunogenicity of a booster dose of Hib-MenCY-TT vaccine will be compared to a booster dose of licensed Hib conjugate vaccine, each administered at 12 to 15 months of age. The group primed with the Hib conjugate vaccine will re-randomized at 12-15 months of age to receive a booster dose of Hib-MenCY-TT or a booster dose of the Hib conjugate vaccine.
Detailed description
The non-inferiority of the immunogenicity, safety, and antibody persistence of Hib-MenCY-TT vaccine will be compared to ActHIB®, a monovalent Hib conjugate vaccine licensed in the US.
All subjects will be vaccinated at 2, 4, 6, and 12 to 15 months. The immunogenicity of the MenC and MenY antigens will be summarized.
MenC and MenY immunogenicity will be compared to Menomune® (a quadrivalent meningococcal A, C, Y, and W-135 plain polysaccharide vaccine licensed in the US) administered to children 3 to 5 years of age.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MenHibrix Group | Experimental | Biological: GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine, Biological: Pediarix, Biological: PrevnarSubjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccinationDuring Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of Menhibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of Menhibrix™ during the Primary Phase received one dose of Menhibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, Menhibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, Menhibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh. |
| ActHIB Group | Active comparator | Biological: ActHIB, Biological: Pediarix, Biological: PrevnarDuring Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either Menhibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively. |
| Menomune Group | Active comparator | Biological: Pediarix, Biological: Prevnar, Biological: MenomuneSubjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region. |
| ActHIB/Menhibrix Group | Experimental | Biological: GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine, Biological: ActHIB, Biological: Pediarix, Biological: PrevnarSubjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of Menhibrix™ and a concomitant fourth dose of Prevnar™. Menhibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively. |
| ActHIB/ActHIB Group | Experimental | Biological: ActHIB, Biological: Pediarix, Biological: PrevnarSubjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively. |
Who may qualify
- Ages
- 6 weeks to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- For Groups A and B
- For Group C
Key exclusion criteria (23 listed)
- -For Groups A and B
- 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 within six months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s).
- Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliovirus, and/or Streptococcus pneumoniae; more than one previous dose of hepatitis B vaccine.
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 influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccinePrimary phase: 3 IM doses Booster phase: 1 IM dose | Biological | ActHIB/Menhibrix Group, MenHibrix Group |
| ActHIBPrimary phase: 3 IM doses Booster phase: 1 IM dose | Biological | ActHIB Group, ActHIB/ActHIB Group, ActHIB/Menhibrix Group |
| PediarixPrimary phase: 3 IM doses | Biological | ActHIB Group, ActHIB/ActHIB Group, ActHIB/Menhibrix Group, MenHibrix Group, Menomune Group |
| PrevnarPrimary phase: 3 IM doses Booster phase: 1 IM dose | Biological | ActHIB Group, ActHIB/ActHIB Group, ActHIB/Menhibrix Group, MenHibrix Group, Menomune Group |
| MenomunePrimary phase: 1 SC dose | Biological | Menomune Group |
Primary outcome
Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value.
Time frame: One month after the 3-dose primary vaccination course (at Month 5)
The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes
Time frame: One month after the 3-dose primary vaccination course (at Month 5)
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations
Time frame: One month after the 3-dose primary vaccination course (at Month 5)
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Number of Subjects Reporting Any Grade 3 Symptoms
Time frame: During the 4-day follow-up period after each primary vaccine dose
"Symptoms" were defined as solicited local and general symptoms and unsolicited adverse events (AEs). A "Grade 3" symptom was defined as any symptom that prevented normal everyday activity. "Any" was defined as an occurrence of any specified symptom regardless of intensity grade. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value
Time frame: One month after the fourth dose (at Month 11-14)
The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB/ActHIB groups .
70 secondary outcomes
Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4
Time frame: One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)
Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4
Time frame: One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
Anti-polysaccharide C (Anti-PSC) Antibody Concentrations
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
Number of Subjects Reporting Medically Attended Visits
Time frame: During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0
Number of Subjects Reporting Rash
Time frame: During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0
Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Anti-PRP Antibody Concentrations
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL)
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Anti-diphtheria and Anti-tetanus Antibody Concentrations
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Number of Subjects With Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentration ≥ 10.0 Milli-international Units Per Milliliter (mIU/mL)
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentrations
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Anti PT, Anti-FHA and Anti-PRN Antibody Concentrations
Time frame: Prior to the primary vaccination course (at Day 0)
Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Number of Subjects With Vaccine Response to PT, FHA and PRN
Time frame: One month after the 3-dose primary vaccination course (at Month 5)
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms
Time frame: Within 4 days (Day 0-3) after the 3-dose primary vaccination
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms
Time frame: Within 8 days (Day 0-7) after the 3-dose primary vaccination
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms
Time frame: Within 4 days (Day 0-3) after the 3-dose primary vaccination
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms
Time frame: Within 8 days (Day 0-7) after the 3-dose primary vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Time frame: From Dose 1 (at Day 0) through Day 30 following the last vaccine dose administered (Day 30 post Month 4 vaccination for MenHibrix and ActHIB groups, Day 30 post Month 1 for Menomune Group).
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: During the entire Primary Phase of the study, from Day 0 up to the end of Primary Phase safety follow-up period (6 months after the last vaccination).
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.
Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs)
Time frame: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine
Number of Subjects Reporting Rash
Time frame: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.
Number of Subjects Reporting Emergency Room (ER) Visits or Visits to Physicians' Office, Related or Not to Common Illnesses
Time frame: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.
Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y)
Time frame: One month post fourth dose vaccination (at Month 11-14)
Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y)
Time frame: One month post fourth dose vaccination (at Month 11-14)
Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y)
Time frame: One month post fourth dose vaccination (at Month 11-14)
Results and safety
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 20035207Marchant CD, Miller JM, Marshall GS, Blatter M, Aris E, Friedland LR, Boutriau D; HibMenCY-TT 005 Study Group. Randomized trial to assess immunogenicity and safety of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine in infants. Pediatr Infect Dis J. 2010 Jan;29(1):48-52. doi: 10.1097/INF.0b013e3181c3ce88.
- Background: PubMed 20072077Marshall GS, Marchant CD, Blatter M, Aris E, Boutriau D, Poolman JT, Friedland LR, Miller JM. Immune response and one-year antibody persistence after a fourth dose of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY) at 12 to 15 months of age. Pediatr Infect Dis J. 2010 May;29(5):469-71. doi: 10.1097/INF.0b013e3181cdd379.
- Background: PubMed 21307655Marshall GS, Marchant CD, Blatter M, Friedland LR, Aris E, Miller JM. Co-administration of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine does not interfere with the immune response to antigens contained in infant vaccines routinely used in the United States. Hum Vaccin. 2011 Feb;7(2):258-64. doi: 10.4161/hv.7.2.14170. Epub 2011 Feb 1.
- 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.
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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
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine, ActHIB and Pediarix in people with Haemophilus Influenzae Type b and Neisseria Meningitidis, run by GlaxoSmithKline at 27 sites in United States.
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 12 inclusion and 23 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 27 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 30 Dec 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-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value. (time frame: One month after the 3-dose primary vaccination course (at Month 5)). The study lists 5 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 NCT00129129, which also lists 4 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.