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Completed

NCT Number: NCT00146835

Post-marketing Safety Study of GSK Biological's Pediarix™ Vaccine

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.

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Key information

Conditions

Hepatitis B Acellular Pertussis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Central Nervous System Diseases Central Nervous System Infections Clostridium Infections Communicable Diseases Corynebacterium Infections DNA Virus Infections Digestive System Diseases Diphtheria Enterovirus Infections Gram-Positive Bacterial Infections Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Picornaviridae Infections Poliomyelitis RNA Virus Infections Spinal Cord Diseases Tetanus Virus Diseases

Age range

6 week–9 month

Sex eligibility

All sexes

Study type

Observational

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pediarix

Biological

1 or more injections

Licensed DTPa containing vaccine

Biological

1 or more injections

Prevnar®: (Wyeth)

Biological

Concomitant vaccination

Primary outcomes

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

    Time frame: During the 8-day period following the primary dose

  2. Medically-attended fever following the first dose of PEDIARIX in Cohort A and DTaP vaccine in Cohort B

    Time frame: Within 4 days following the first dose

Secondary outcomes

  1. All seizures following the primary doses of PEDIARIX or DTaP vaccine

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

  2. Medically-attended fever

    Time frame: 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

  3. Seizures associated with fever following the primary doses of PEDIARIX or DTaP vaccine

    Time frame: 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

  4. Allergic reactions, in cohorts A, B & C

    Time frame: 0 to 48 hours following the primary doses of PEDIARIX or DTaP vaccine

  5. Outpatient visits for any cause following the primary doses of PEDIARIX or DTaP vaccine

    Time frame: Day 0-20, Cohort A; Day 0-20, Cohort B; Day 21-41, Cohort A; Day 0-20, Cohort C

  6. Hospitalizations for any cause following the primary doses of PEDIARIX or DTaP vaccine

    Time frame: Day 0-20, Cohort A, Day 0-20, Cohort B; Day 21-41, Cohort A; Day 0-20, Cohort C

  7. Hospitalizations for any cause following PEDIARIX or DTaP vaccine

    Time frame: 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

  8. Deaths

    Time frame: 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • Kaiser Permanente
  • University of California, Los Angeles

Registry information

Official study 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)

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 7, 2005
Registry last updated
Jan 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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