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

NCT00146835 | Completed

• 1 other identifier: 217744/088
• Study Type: observational
• Target: 120,794
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis B; Poliomyelitis; Diphtheria; Tetanus; Acellular Pertussis

Outcome Measures

Primary Outcomes (2)

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

  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

  Within 4 days following the first dose

Secondary Outcomes (8)

• All seizures following the primary doses of PEDIARIX or DTaP vaccine

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

• Medically-attended fever

  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

  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

  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

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

Study Arms (3)

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.

Biological: Pediarix; Biological: Prevnar®: (Wyeth)

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.

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

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.

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

Interventions

Pediarix BIOLOGICAL

1 or more injections

Cohort A

Licensed DTPa containing vaccine BIOLOGICAL

1 or more injections

Cohort B; Cohort C

Prevnar®: (Wyeth) BIOLOGICAL

Concomitant vaccination

Cohort A; Cohort B; Cohort C

Eligibility Criteria

• Age: 6 Weeks - 9 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The study will be conducted by the University of California, Los Angeles (UCLA) Center for Vaccine Research (CVR) and the Southern California Kaiser Permanente Health Care Plan (SCKP), the largest Health Maintenance Organization (HMO) in California. All infants who receive at least one dose of PEDIARIX in the primary series will be identified through the automated Kaiser Immunization Tracking System (KITS).

You may qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Kaiser Permanente: collaborator
• University of California, Los Angeles: collaborator

Related Publications (1)

• 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.

  PMID: 19047220 BACKGROUND

MeSH Terms

Conditions

Hepatitis B; Poliomyelitis; Diphtheria; Tetanus

Interventions

PEDIARIX; Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 7, 2005
• Study Start: April 1, 2003
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: January 13, 2014

Record last verified: 2014-01