Safety Study of a Vaccine Against Meningitis in Infants ( 2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.
Phase 3
Completed
- Conditions
- Haemophilus Influenzae Type bDiphtheriaWhole Cell PertussisHepatitis BTetanus
- Registration Number
- NCT00317135
- Lead Sponsor
- GlaxoSmithKline
- 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™
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 3 Days 0-3 post dose 3 Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 2 Days 0-3 post dose 2
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (1)
GSK Investigational Site
🇵🇭Muntinlupa, Philippines
GSK Investigational Site🇵🇭Muntinlupa, Philippines