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A Phase IIb Randomized, Double-blind, Controlled Study of the Safety, Immunogenicity and Proof-of-concept of RTS,S/AS02D, a Candidate Malaria Vaccine, When Incorporated Into an Expanded Program on Immunization (EPI) Regimen That Includes DTPw/Hib in Infants Living in a Malaria-endemic Region

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Trial Profile

A Phase IIb Randomized, Double-blind, Controlled Study of the Safety, Immunogenicity and Proof-of-concept of RTS,S/AS02D, a Candidate Malaria Vaccine, When Incorporated Into an Expanded Program on Immunization (EPI) Regimen That Includes DTPw/Hib in Infants Living in a Malaria-endemic Region

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Sep 2023

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At a glance

  • Drugs GSK 257049 (Primary) ; Hepatitis B vaccine recombinant; Hib-DTP vaccine; Poliovirus vaccine live oral
  • Indications Diphtheria; Falciparum malaria; Haemophilus infections; Hepatitis B; Influenza B virus infections; Malaria; Pertussis; Poliomyelitis; Tetanus
  • Focus Adverse reactions; Pharmacodynamics; Proof of concept; Therapeutic Use
  • Sponsors GlaxoSmithKline; GSK

    • Most Recent Events

    • 09 Mar 2010 Actual end date (Jan 2009) added as reported by ClinicalTrials.gov.
    • 11 Dec 2008 Results have been published in the New England Journal of Medicine.
    • 09 Dec 2008 Results presented at the American Society for Tropical Medicine and Hygeine.

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