NCT00146835

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

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
• Phase: —
• Study type: Observational
• Enrollment: 120,794 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 9 Months
• Healthy volunteers: Accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Pediarix	1 or more injections
BIOLOGICAL	Licensed DTPa containing vaccine	1 or more injections
BIOLOGICAL	Prevnar®: (Wyeth)	Concomitant vaccination

Timeline

• Start date: 2003-04-01
• Primary completion: 2006-06-01
• Completion: 2006-06-01
• First posted: 2005-09-07
• Last updated: 2014-01-13