Randomized, Single Blinded Study of the Safety and Immunogenicity of Pentavalent DTaP-Hep B-IPV Combination Vaccine (Pediarix; GlaxoSmithKline (GSK) Biologicals) Administered to Healthy Neonates and Infants at Birth, 2, and 6 Months of Age Compared to a Routine Infant Schedule at 2, 4, and 6 Months of Age.
Phase of Trial: Phase II
Latest Information Update: 09 Jun 2011
At a glance
- Drugs DTaP-hepatitis B-poliovirus vaccine (Primary) ; Hepatitis B vaccine recombinant
- Indications Diphtheria; Hepatitis B; Pertussis; Poliomyelitis; Tetanus
- Focus Pharmacodynamics
- 22 Sep 2009 Planned number of patients changed from 205 to 5 as reported by ClinicalTrials.gov.
- 23 Oct 2008 Planned end date changed from 1 Mar 2008 to 1 Aug 2006 as reported by ClinicalTrials.gov.
- 23 Oct 2008 Actual start date changed from Oct 2005 to Dec 2005 as reported by ClinicalTrials.gov.