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.

Trial Profile

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.

Completed
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
  • Most Recent Events

    • 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.
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