Immunogenicity & Safety Study of a Vaccine Against Meningitis in Infants (2,4,6 Months) After a Hepatitis B Birth Dose.

Study Overview
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Brief Summary
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The purpose of the study is to demonstrate consistent results in 3 production lots of Hib-MenAC vaccine when extemporaneously mixed with Tritanrix™-HepB and administered as a single injection, with respect to immunogenicity, safety and reactogenicity. Tritanrix™-HepB/Hiberix™ given alone and Wyeth Lederle's meningococcal C conjugate vaccine (Meningitec™), given concomitantly with Tritanrix™-HepB/Hiberix™ will be used as benchmark vaccines for all antigens except for MenA. The immunogenicity of MenA will also be evaluated.

Detailed Description
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Randomized study with five groups to receive one of the following vaccination regimens after a birth dose of hepatitis B vaccine: One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HBV (3 different groups) GSK Biologicals' Tritanrix™-HBV/Hiberix™ GSK Biologicals' Tritanrix™-HBV/Hiberix™ +Meningitec™

Official Title
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Study to Show Lot-to-lot Consistency of Hib-MenAC Mixed With Tritanrix™-HBV, Its Non-inferiority to Tritanrix™-HBV/Hiberix™ With or Without Meningitec™, and MenA Response in 2, 4, 6 Month Infants With Hepatitis B Birth Dose

Conditions
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Diphtheria, Hepatitis B, Haemophilus Influenzae Type b, Whole Cell Pertussis, Tetanus

Intervention / Treatment
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* Biological: DTPw-HBV/Hib-MenAC conjugate vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: • Healthy infants 56-83 days of age, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks and received a birth dose of hepatitis B vaccine within the first 72 hours of life. Exclusion criteria: Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history & physical examination. Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period with the exception of oral polio vaccine (OPV). Use of any investigational or non-registered 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 (>14 days) of immunosuppressants or other immune-modifying drugs since birth. Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life. Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and/or meningococcal disease.

Ages Eligible for Study
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Minimum Age: 56 Days
Maximum Age: 83 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: DTPw-HBV/Hib-MenAC conjugate vaccine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-dose 3, bactericidal titers & antibody levels to meningococcal serogroups A & C; & PRP; & antibody levels to HBs, diphtheria, tetanus & BPT (subset of subjects). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solicited events (day 0-3); unsolicited events (day 0-30); serious adverse events (entire study). Pre-dose 1, antibody levels to Men(A&C) & PRP; & in some subjects anti-BPT antibody levels Seropositivity/seroprotection/vaccine response & antibody levels |  |  |