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Hepatitis BNCT00146835

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

An observational study of Hepatitis B and Poliomyelitis, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 weeks to 9 monthsHealthy volunteers can take part
Conditions the study is for
Hepatitis B, Poliomyelitis, Diphtheria
What is being tested?
Pediarix, Licensed DTPa containing vaccine and Prevnar®: (Wyeth)
How many people
120,794 participants
Where
No sites listed yet
Study dates
Apr 2003to Jun 2006
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 weeks to 9 months
  • All sexes
  • Healthy volunteers accepted
  • Child

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).

Who may be able to join

  • 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.

Who cannot join

None listed.

About this study

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)

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.

Read the 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.
Being tested
Pediarix, Licensed DTPa containing vaccine, Prevnar®: (Wyeth)
Medical subject headings
Hepatitis B, Poliomyelitis, Diphtheria, Tetanus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PediarixBiological

    1 or more injections

  • Licensed DTPa containing vaccineBiological

    1 or more injections

  • Prevnar®: (Wyeth)Biological

    Concomitant vaccination

Study groups in NCT00146835
Study groupRoleWhat they receive
Cohort AThe 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.
Receives: Biological: Pediarix; Biological: Prevnar®: (Wyeth)
Cohort BThis 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.
Receives: Biological: Licensed DTPa containing vaccine; Biological: Prevnar®: (Wyeth)
Cohort CThis "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.
Receives: Biological: Licensed DTPa containing vaccine; Biological: Prevnar®: (Wyeth)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: During the 8-day period following the primary dose

  2. Medically-attended fever following the first dose of PEDIARIX in Cohort A and DTaP vaccine in Cohort B

    Measured: Within 4 days following the first dose

Secondary outcomes (8)

  1. All seizures following the primary doses of PEDIARIX or DTaP vaccine

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

  2. Medically-attended fever

    Measured: 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

  3. Seizures associated with fever following the primary doses of PEDIARIX or DTaP vaccine

    Measured: 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

  4. Allergic reactions, in cohorts A, B & C

    Measured: 0 to 48 hours following the primary doses of PEDIARIX or DTaP vaccine

  5. Outpatient visits for any cause following the primary doses of PEDIARIX or DTaP vaccine

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

  6. Hospitalizations for any cause following the primary doses of PEDIARIX or DTaP vaccine

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

  7. Hospitalizations for any cause following PEDIARIX or DTaP vaccine

    Measured: 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

  8. Deaths

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2005 (estimated)
  2. Study startApr 2003
  3. Primary completionJun 2006
  4. Study completionJun 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
120,794 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00146835
Sponsor's protocol ID
217744/088
Status last verified
Jan 2014
First submitted
6 Sep 2005
Last updated
13 Jan 2014
Results posted
No

Publications

  • 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.

    PubMed 19047220

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis B and Poliomyelitis, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00146835, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2014.

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