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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.

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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.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Jul 2022

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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; GSK

    • Most Recent Events

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

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