A Phase IV, Single-blind, Randomized, Controlled, Monocentric Study to Assess the Interchangeability of Quinvaxem (DTwP-HepB-Hib) as the 2nd and 3rd Dose After Initial Vaccination With Tritanrix HB+Hib (DTwP-HepB/Hib) With Respect to Safety and Immunogenicity in Healthy Infants at 6, 10 and 14 Weeks of Age.

Trial Profile

A Phase IV, Single-blind, Randomized, Controlled, Monocentric Study to Assess the Interchangeability of Quinvaxem (DTwP-HepB-Hib) as the 2nd and 3rd Dose After Initial Vaccination With Tritanrix HB+Hib (DTwP-HepB/Hib) With Respect to Safety and Immunogenicity in Healthy Infants at 6, 10 and 14 Weeks of Age.

Completed
Phase of Trial: Phase IV

Latest Information Update: 28 Oct 2013

At a glance

  • Drugs Hib-DTP-hepatitis B vaccine (Primary) ; Hib-DTP hepatitis B vaccine (Tritanrix-HepB/Hiberix)
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Pertussis; Tetanus
  • Focus Pharmacodynamics
  • Sponsors Crucell
  • Most Recent Events

    • 28 Oct 2013 Primary endpoint of seroprotection rate (anti-PRP antibodies) has been met according to results published in Vaccine.
    • 18 Jul 2012 Actual end date (Jul 2011) added as reported by ClinicalTrials.gov.
    • 15 Sep 2011 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
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