Status:
COMPLETED
Post-marketing Safety Study of GSK Biological's Pediarix™ Vaccine
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
Kaiser Permanente
University of California, Los Angeles
Conditions:
Hepatitis B
Poliomyelitis
Eligibility:
All Genders
6-9 years
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...
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 hospit...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Primary study cohort
- The primary study cohort will include all infants from SCKP who have begun their primary course of vaccine with PEDIARIX co-administered with Prevnar and for whom at least one dose of PEDIARIX was administered prior to the infant's 9-month birthday and safety follow-up information is available.
- Control cohorts
- Three control cohorts will be evaluated.
- The historical cohort will include age-, gender- and area-matched infants from SCKP who received at least one dose of DTaP vaccine co-administered with Prevnar prior to the infant's 9-month birthday and for whom safety follow-up information is available. This cohort will include infants vaccinated between January, 2002 and March, 2003.
- The self-control cohort is defined for the study subject as the 20-day post-vaccination period from Day 21 to Day 41 for each infant in the primary cohort (PEDIARIX co-administered with Prevnar as the primary vaccination course).
- The "delayed PEDIARIX use clinic" cohort will include all infants from SCKP who, during the enrollment period for the primary cohort, began their primary course of vaccination with DTaP vaccine and for whom at least one dose of DTaP vaccine was co-administered with Prevnar prior to the infant's 9-month birthday and safety follow-up information is available. The size of this cohort will depend on how quickly individual SCKP clinics and medical centers use PEDIARIX once it is made available. The size of this cohort, therefore, is not immediately predictable.
- Exclusion Criteria: none
Exclusion
Key Trial Info
Start Date :
April 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
120794 Patients enrolled
Trial Details
Trial ID
NCT00146835
Start Date
April 1 2003
End Date
June 1 2006
Last Update
January 13 2014
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