Last updated: 11/04/2018 01:12:12

Post-marketing safety study of GSK Biological's Pediarix™ vaccine

GSK study ID
217744/088
See study documents
Clinicaltrials.gov ID
NCT00146835
EudraCT ID
2011-004050-26
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Phase IV, prospective study of the safety of GSK Bios' Pediarix administered to a cohort of infants in a US Health Maintenance Organization (HMO). (Post-Marketing PEDIARIX Safety Study)
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

All seizures following the primary doses of PEDIARIX in Cohort A and DTaP vaccine in Cohort B

Timeframe: 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

Timeframe: Within 4 days following the first dose

Secondary outcomes:

All seizures following the primary doses of PEDIARIX or DTaP vaccine

Timeframe: Day 21-41, in Cohort A; Day 0-7, in Cohort C

Medically-attended fever

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Interventions:
Biological/vaccine: Pediarix
Biological/vaccine: Licensed DTPa containing vaccine
Biological/vaccine: Prevnar®: (Wyeth)
Enrollment:
120794
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Zangwill, KM et al. (2008) A Population-based, Post-Licensure Evaluation of the Safety of a Combination Diphtheria, Tetanus, Acellular Pertussis, Hepatitis B, Inactivated Poliovirus Combination Vaccine in a Large Managed Care Organization. Pediatrics. 122(6):e1179-e1185.
Zangwill KM et al. (2008) A Population-based, Post-Licensure Evaluation of the Safety of a Combination Diphtheria, Tetanus, Acellular Pertussis, Hepatitis B, Inactivated Poliovirus Combination Vaccine in a Large Managed Care Organization. Pediatrics. 122(6):e1179-e1185.
Medical condition
Hepatitis B, Poliomyelitis, Diphtheria, Tetanus, acellular pertussis
Product
SB217744
Collaborators
Southern California Kaiser Permanente Health Care Plan, UCLA Center for Vaccine Research
Study date(s)
April 2003 to June 2006
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
6 weeks - 9 months
Accepts healthy volunteers
Yes
  • 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.
  • none
Inclusion and exclusion criteria
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. 1. 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. 2. 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). 3. 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

Trial location(s)

No location data available.

Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2006-10-06

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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