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.
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History