Clinical trial

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

NCT00146835 · GlaxoSmithKline, Industry · Completed

Key facts

NCT number NCT00146835
Title Post-marketing Safety Study of GSK Biological's Pediarix™ Vaccine
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)
Lead sponsor GlaxoSmithKline, Industry
Collaborators Kaiser Permanente University of California, Los Angeles
Status Completed
Study type Observational
Conditions Hepatitis B, Poliomyelitis, Diphtheria, Tetanus, Acellular Pertussis
Intervention type Biological
Interventions Pediarix, Licensed DTPa containing vaccine, Prevnar®: (Wyeth)
Enrollment 120,794
Start date Apr 1, 2003
Primary completion Jun 1, 2006
Completion Jun 1, 2006
First posted Sep 7, 2005
Last update posted Jan 13, 2014

At a glance

  • No Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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