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

This study has been completed.
Sponsor:
Collaborators:
Kaiser Permanente
University of California, Los Angeles
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00146835
First received: September 6, 2005
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Hepatitis B
Poliomyelitis
Diphtheria
Tetanus
Acellular Pertussis
Biological: Pediarix
Biological: Licensed DTPa containing vaccine
Biological: Prevnar®: (Wyeth)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Allergic reactions, in cohorts A, B & C [ Time Frame: 0 to 48 hours following the primary doses of PEDIARIX or DTaP vaccine ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 120794
Study Start Date: April 2003
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
1 or more injections
Biological: Prevnar®: (Wyeth)
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.
Biological: Licensed DTPa containing vaccine
1 or more injections
Biological: Prevnar®: (Wyeth)
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.
Biological: Licensed DTPa containing vaccine
1 or more injections
Biological: Prevnar®: (Wyeth)
Concomitant vaccination

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.
  Eligibility

Ages Eligible for Study:   6 Weeks to 9 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146835

Sponsors and Collaborators
GlaxoSmithKline
Kaiser Permanente
University of California, Los Angeles
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00146835     History of Changes
Other Study ID Numbers: 217744/088
Study First Received: September 6, 2005
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diphtheria
Hepatitis
Hepatitis A
Hepatitis B
Whooping Cough
Poliomyelitis
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Myelitis
Central Nervous System Viral Diseases
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 20, 2014