Post-marketing Safety Study of GSK Biological's Pediarix™ Vaccine
Completed
- Conditions
- Hepatitis BPoliomyelitisDiphtheriaTetanusAcellular Pertussis
- Registration Number
- NCT00146835
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Pre-licensure studies of GSK Biologicals' PEDIARIX vaccine have shown it to be generally safe and unlikely to result in vaccine-associated serious adverse events. This post-licensure study is designed to evaluate relatively uncommon/rare outcomes in a large population cohort.
- Detailed Description
* The outcomes to be assessed include the occurrence of all seizures (with or without fever), medically-attended fever, seizures associated with fever, allergic reactions, outpatient visits and hospitalizations for any cause, and all deaths.
* Data collection through utilization of automated databases at the study site with subset medical record review. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120794
Inclusion Criteria
Not provided
Exclusion Criteria
none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All seizures following the primary doses of PEDIARIX in Cohort A and DTaP vaccine in Cohort B During the 8-day period following the primary dose Medically-attended fever following the first dose of PEDIARIX in Cohort A and DTaP vaccine in Cohort B Within 4 days following the first dose
- Secondary Outcome Measures
Name Time Method All seizures following the primary doses of PEDIARIX or DTaP vaccine Day 21-41, in Cohort A; Day 0-7, in Cohort C Medically-attended fever Day 0-3 after 2nd and 3rd doses of PEDIARIX in Cohort A;Day 0-3 after 2nd and 3rd doses of DTaP vaccine in Cohort B;Day 21-41 after primary doses of PEDIARIX in the Cohort A;Day 0-3 after primary doses of DTaP vaccine in the Cohort C Seizures associated with fever following the primary doses of PEDIARIX or DTaP vaccine Day 0-3 after 2nd and 3rd doses of PEDIARIX in Cohort A;Day 0-3 after 2nd and 3rd doses of DTaP vaccine in Cohort B;Day 21-41 after primary doses of PEDIARIX in the Cohort A;Day 0-3 after primary doses of DTaP vaccine in the Cohort C Allergic reactions, in cohorts A, B & C 0 to 48 hours following the primary doses of PEDIARIX or DTaP vaccine Outpatient visits for any cause following the primary doses of PEDIARIX or DTaP vaccine Day 0-20, Cohort A; Day 0-20, Cohort B; Day 21-41, Cohort A; Day 0-20, Cohort C Hospitalizations for any cause following the primary doses of PEDIARIX or DTaP vaccine Day 0-20, Cohort A, Day 0-20, Cohort B; Day 21-41, Cohort A; Day 0-20, Cohort C Hospitalizations for any cause following PEDIARIX or DTaP vaccine Day 0 post dose 1 to Day 41 following the last dose and from Day 42 post last dose to 1 year following the last dose Deaths Day 0 post dose 1 to Day 41 following the last dose and from Day 42 post last dose to 1 year following the last dose