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)

Status Completed

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.

Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

• NCT number: NCT00146835
• Study type: Observational
• Source: GlaxoSmithKline
• Status: Completed
• Phase: N/A
• Start date: April 2003
• Completion date: June 2006