Assess Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Admnd at 3 & 4 Mths & DTPa-HBV-IPV/Hib Vaccine Admnd at 5 Mths, Followed by DTPa-IPV/Hib Vaccine at 18 Mths in Infants Who Received hepatitisB Vaccine at Birth & at One Month of Age
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Haemophilus Influenzae Type b
- Sponsor
- GlaxoSmithKline
- Enrollment
- 702
- Locations
- 1
- Primary Endpoint
- Number of Subjects Reporting Any Solicited Local Symptoms
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib vaccine. This DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed Description
Single group study. Subjects in GSK Biologicals' rotavirus study (Rota-028) in Singapore will be enrolled in this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Subjects Reporting Any Solicited Local Symptoms
Time Frame: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Assessed solicited local and general symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Number of Subjects Reporting Any Solicited General Symptoms
Time Frame: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Assessed solicited general symptoms were drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.
Secondary Outcomes
- Number of Subjects Reporting Any Serious Adverse Events (SAEs)(During the entire study period (from Month 0 up to Month 21))
- Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)(During the 31-day (Days 0-30) post-vaccination period)
- Number of Subjects Reporting Any Large Swelling Reactions(At Month 15, post-booster dose)