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).
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
- 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.