Diphtheria, Haemophilus Influenzae Type b, Hepatitis B, Tetanus, Whole Cell Pertussis
Conditions
Brief summary
The purpose of this study is to compare the reactogenicity & safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.
Detailed description
Randomized study with four groups to receive one of the following vaccination regimens after a dose of hepatitis B vaccine given at birth: * One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HepB (3 different groups) * GSK Biologicals' Tritanrix™-HepB/Hiberix™
Interventions
The full content of two monodose vials of Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Meningitec (5/5/5) vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): one dose of 0.5 ml of the reconstituted Tritanrix- HepB/Meningitec vaccine was withdrawn from the vial and administered, the needle was changed before injection
BIOLOGICALTritanrix/Hiberix vaccine
The full content of the Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Hiberix vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): the full volume of the mixed vaccines was withdrawn from the vial, the needle was changed before injection.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Eligibility
Sex/Gender
ALL
Age
56 Days to 83 Days
Healthy volunteers
Yes
Inclusion criteria
• Healthy infants 56-83 days of age at the time of the first vaccine dose, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks & has received a birth dose of hepatitis B vaccine within the first 3 days of life.
Exclusion criteria
* Any confirmed immunodeficient condition, based on medical history and 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 (defined as more than 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. * History of diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease or known exposure to these diseases since birth. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 1 | Days 0-3 post dose 1 |
| Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 2 | Days 0-3 post dose 2 |
| Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 3 | Days 0-3 post dose 3 |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of solicited symptoms other than fever >38.5°C (axillary) during the 4-day follow-up period after each dose | Days 0-3 after each dose |
| Occurrence of unsolicited symptoms during the 31-day follow-up period after each dose | Day 0-30 after each dose |
| Occurrence of serious adverse events during the entire study period | Day 0 up to Month 5 |
Countries
Thailand
Outcome results
None listed