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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

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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