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
Study complete
Study complete
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
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    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
    • Inclusion criteria:
    • Primary study cohort
    Inclusion and exclusion criteria
    Inclusion 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)

    This study does not involve prospective enrollment of participants.

    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
    Study complete
    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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