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An Open-label, Randomized, Controlled, Single Centre, Phase IIb Study to Assess the Immunogenicity, Reactogenicity and Safety of Three Live Oral Rotavirus Vaccines, ROTAVAC, ROTAVAC 5CM and Rotarix in Healthy Zambian Infants

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Trial Profile

An Open-label, Randomized, Controlled, Single Centre, Phase IIb Study to Assess the Immunogenicity, Reactogenicity and Safety of Three Live Oral Rotavirus Vaccines, ROTAVAC, ROTAVAC 5CM and Rotarix in Healthy Zambian Infants

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 21 May 2021

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At a glance

  • Drugs ORV 116E (Primary) ; Bovine rotavirus vaccine reassortant; RIX 4414
  • Indications Rotavirus infections
  • Focus Pharmacodynamics
  • Acronyms ROTAVAC

    • Most Recent Events

    • 12 May 2021 Primary endpoint has been met. (Geometric Mean Concentration using WC3 as the viral lysate),as per results published in the Vaccine
    • 12 May 2021 Results published in the Vaccine
    • 18 Feb 2020 Status changed from active, no longer recruiting to completed.
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