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).

Trial Profile

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).

Completed
Phase of Trial: Phase IV

Latest Information Update: 01 May 2016

At a glance

  • Drugs DTaP-hepatitis B-poliovirus vaccine (Primary) ; Pneumococcal 7-valent CRM197 vaccine conjugate
  • Indications Diphtheria; Hepatitis B; Pertussis; Pneumococcal infections; Poliomyelitis; Tetanus
  • Focus Adverse reactions
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 07 Dec 2012 Actual end date changed from 1 May 2006 to 1 Jun 2006 as reported by ClinicalTrials.gov.
    • 10 Sep 2008 GlaxoSmithKline Biologicals reported as trial affiliate by ClinicalTrials.gov.
    • 10 Sep 2008 Primary endpoint identified as seizures and medically-attended fever after the first dose of vaccine as reported by ClinicalTrials.gov.
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