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

January 9, 2014 updated by: GlaxoSmithKline

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

120794

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 9 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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: Prevnar®: (Wyeth)
Concomitant vaccination
Biological: Licensed DTPa containing vaccine
1 or more injections
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: Prevnar®: (Wyeth)
Concomitant vaccination
Biological: Licensed DTPa containing vaccine
1 or more injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: Within 4 days following the first dose
Within 4 days following the first dose

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Day 21-41, in Cohort A; Day 0-7, in Cohort C
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
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
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
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
Time Frame: 0 to 48 hours following the primary doses of PEDIARIX or DTaP vaccine
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
Time Frame: Day 0-20, Cohort A; Day 0-20, Cohort B; Day 21-41, Cohort A; Day 0-20, Cohort C
Day 0-20, Cohort A; Day 0-20, Cohort B; Day 21-41, Cohort A; Day 0-20, Cohort C
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
Day 0-20, Cohort A, Day 0-20, Cohort B; Day 21-41, Cohort A; Day 0-20, Cohort C
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Collaborators

University of California, Los Angeles
Kaiser Permanente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (ACTUAL)

June 1, 2006

Study Completion (ACTUAL)

June 1, 2006

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (ESTIMATE)

September 7, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 13, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 217744/088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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