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

NCT ID: NCT00146835

Last Updated: 2014-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120794 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2006-06-30

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 to evaluate relatively uncommon/rare outcomes in a large population cohort.

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 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.

Conditions

Hepatitis B; Poliomyelitis; Diphtheria; Tetanus; Acellular Pertussis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort A

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.

Pediarix

Intervention Type: BIOLOGICAL

1 or more injections

Prevnar®: (Wyeth)

Intervention Type: BIOLOGICAL

Concomitant vaccination

Cohort B

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.

Licensed DTPa containing vaccine

Intervention Type: BIOLOGICAL

1 or more injections

Prevnar®: (Wyeth)

Intervention Type: BIOLOGICAL

Concomitant vaccination

Cohort C

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.

Licensed DTPa containing vaccine

Intervention Type: BIOLOGICAL

1 or more injections

Prevnar®: (Wyeth)

Intervention Type: BIOLOGICAL

Concomitant vaccination

Interventions

Pediarix

1 or more injections

Intervention Type: BIOLOGICAL

Licensed DTPa containing vaccine

1 or more injections

Intervention Type: BIOLOGICAL

Prevnar®: (Wyeth)

Concomitant vaccination

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 9 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

Zangwill KM, Eriksen E, Lee M, Lee J, Marcy SM, Friedland LR, Weston W, Howe B, Ward JI. A population-based, postlicensure evaluation of the safety of a combination diphtheria, tetanus, acellular pertussis, hepatitis B, and inactivated poliovirus vaccine in a large managed care organization. Pediatrics. 2008 Dec;122(6):e1179-85. doi: 10.1542/peds.2008-1977.

Reference Type: BACKGROUND

PMID: 19047220 (View on PubMed)

Other Identifiers

217744/088

Identifier Type: -

Identifier Source: org_study_id