Diphtheria, Haemophilus Influenzae Type b, Hepatitis B, Tetanus, Whole Cell Pertussis
Conditions
Keywords
Haemophilus influenzae type b, diphtheria, tetanus, Prophylaxis diphtheria, pertussis, hepatitis B, meningococcal serogroups A & C diseases
Brief summary
The primary purpose of this study is to demonstrate the lot-to-lot consistency of 3 production lots of GSK Biologicals' Hib-MenAC (Haemophilus influenzae type b and meningococcal serogroups A and C) vaccine when reconstituted with Tritanrix™-HepB (diphtheria, tetanus, pertussis, and hepatitis B) vaccine and administered as a single injection.
Detailed description
The study is double blind. However the active control vaccine Tritanrix™-HepB/Hiberix™ will be administered in a single-blind manner. Blood samples will be collected for immunogenicity analyses. GSK Biologicals' OPV vaccine will be administered concomitantly with the study vaccines at 2, 4 and 6 months of age according to local country regulation. The study will last approximately 5 months per subject
Interventions
BIOLOGICALHib-MenAC mixed with Tritanrix™-HepB
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
56 Days to 83 Days
Healthy volunteers
Yes
Inclusion criteria
* healthy male or female, between, and including, 56 and 83 days of age. * Born after a gestation period between 36 and 42 weeks * Birth dose of hepatitis B vaccine within the first 72 hours of life
Exclusion criteria
* 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. * Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life. * History of OR previous vaccination against OR known exposure since birth to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection * A family history of congenital or hereditary immunodeficiency * History of any neurologic disorders or seizures * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immune response 1 month post dose 3 (SBA-MenA/C titers ≥ 1:8, anti-PRP ≥ 0.15 µg/ml, -diphtheria ≥ 0.1 IU/ml (ELISA) OR ≥ 0.016 IU/ml (Vero-cell test), -tetanus ≥ 0.1 IU/ml, -HB concentration ≥ 10 mIU/ml, vaccine response to Bordetella pertus | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibody conc or titer, seroprot, seropos and/or vacc response to all antigens administered (Prior to dose 1, 2 m after dose 2 & 1m after dose 3). After each dose: Solicited (d 0-3, local/general), unsolicited (d 0-30) symptoms. During whole study: SAEs | — |
Countries
Thailand
Outcome results
None listed