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

Hepatitis B Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146835
• Other study ID #: 217744/088
• Status: Completed
• Phase: N/A
• First received: September 6, 2005
• Last updated: January 9, 2014
• Start date: April 2003
• Est. completion date: June 2006

Study information

• Verified date: January 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120794
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 9 Months

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acellular Pertussis
• Diphtheria
• Hepatitis B
• Poliomyelitis
• Tetanus

Intervention

Biological:
• Pediarix
1 or more injections
• Licensed DTPa containing vaccine
1 or more injections
• Prevnar®: (Wyeth)
Concomitant vaccination

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
GlaxoSmithKline	Kaiser Permanente, University of California, Los Angeles

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	All seizures following the primary doses of PEDIARIX or DTaP vaccine		Day 21-41, in Cohort A; Day 0-7, in Cohort C	No
Secondary	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	No
Secondary	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	No
Secondary	Allergic reactions, in cohorts A, B & C		0 to 48 hours following the primary doses of PEDIARIX or DTaP vaccine	No
Secondary	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	No
Secondary	Hospitalizations 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	No
Secondary	Hospitalizations for any cause following PEDIARIX or DTaP vaccine		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	No
Secondary	Deaths		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	No