Assess the Immune Response Following Primary Vaccination With GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ Given at 6,10 & 14 Wks of Age to Infants Who Received Hepatitis B Vaccine at Birth
Phase 3
Completed
- Conditions
- Diphtheria; Haemophilus Influenzae Type b; Hepatitis B; Tetanus; Whole Cell Pertussis
- Registration Number
- NCT00317122
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study will only include infants born to mothers who are tested as seronegative for human immunodeficiency virus (HIV) \& hepatitis B surface antigen (HBsAg). The purpose of this study is to demonstrate in infants who received a birth dose of hepatitis B vaccine that Tritanrix™-HepB/Hib-MenAC vaccine is at least as good as Tritanrix™-HepB/Hiberix™ with respect to immunogenicity of the hepatitis B antigen.
- Detailed Description
Randomized study with two groups to receive one of the following vaccination regimens:
* GSK Biologicals' Tritanrix™-HepB/Hib-MenAC
* GSK Biologicals' Tritanrix™-HepB/Hiberix™
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 192
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method One month after the third dose of the primary vaccination, measurement of anti-HBs antibody concentrations.
- Secondary Outcome Measures
Name Time Method Immunogenicity: One month after the third dose of the primary vaccination, antibody concentrations or titres against all other vaccine antigens. Reactogenicity and safety: after each dose: solicited (day 0-3, local & general) & unsolicited (day 0-30) symptoms. Over the full course of the study: serious adverse events (SAEs)"
Trial Locations
- Locations (1)
GSK Investigational Site
🇿🇦Ga-Rankuwa, South Africa