A Phase III, Partially Blind, Randomized Study to Evaluate the Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Tritanrix™-HepB and GSK Biologicals Kft's DTPw-HBV Vaccines as Compared to Concomitant Administration of Commonwealth Serum Laboratory's (CSL's) DTPw (Triple Antigen™) and GSK Biologicals' HBV (Engerix™-B), When Co-administered With GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine, to Healthy Infants at 3, 4½ and 6 Months of Age, After a Birth Dose of Hepatitis B Vaccine.

Trial Profile

A Phase III, Partially Blind, Randomized Study to Evaluate the Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Tritanrix™-HepB and GSK Biologicals Kft's DTPw-HBV Vaccines as Compared to Concomitant Administration of Commonwealth Serum Laboratory's (CSL's) DTPw (Triple Antigen™) and GSK Biologicals' HBV (Engerix™-B), When Co-administered With GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine, to Healthy Infants at 3, 4½ and 6 Months of Age, After a Birth Dose of Hepatitis B Vaccine.

Completed
Phase of Trial: Phase III

Latest Information Update: 14 Jul 2017

At a glance

  • Drugs DTP-hepatitis B vaccine (Primary) ; Diphtheria tetanus and pertussis vaccine; Hepatitis B vaccine recombinant; RIX 4414
  • Indications Diphtheria; Hepatitis B; Pertussis; Rotavirus infections; Tetanus
  • Focus Pharmacodynamics
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 29 Sep 2006 Status change
    • 09 Dec 2005 New trial record.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top