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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Poliomyelitis; Diphtheria; Tetanus; Hepatitis B; Acellular Pertussis

Treatments: Biological: Pediarix; Biological: Prevnar®: (Wyeth); Biological: Licensed DTPa containing vaccine

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00146835

217744/088

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120,794 patients

Sex: All

Ages: 6 weeks to 9 months old

Volunteers: Accepts Healthy Volunteers

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 design

120,794 participants in 3 patient groups

Cohort A

Description:

The primary study cohort includes 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.

Treatment:

Biological: Prevnar®: (Wyeth)

Biological: Pediarix

Cohort B

Description:

This Historical cohort includes age-, gender- and area-matched infants who received at least one dose of DTaP vaccine co-administered with 7Pn between 1 January 2002 and 29 April 2003.

Treatment:

Biological: Prevnar®: (Wyeth)

Biological: Licensed DTPa containing vaccine

Cohort C

Description:

This "delayed Pediarix use clinics" cohort includes all infants who, during the enrollment period for Cohort A, begin their primary course of vaccination with a DTaP vaccine co-administered with 7Pn. It is age-, gender-, and area-matched in a similar manner to Cohort B.

Treatment:

Biological: Prevnar®: (Wyeth)

Biological: Licensed DTPa containing vaccine