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A Randomized Phase I/II Study to Evaluate Safety & Reactogenicity of Heat Stable Rotavirus Vaccine, in Healthy Adult; Followed by Evaluation of the Safety, Reactogenicity & Immunogenicity of a 3-dose Series in Infants Age 6-8 Weeks

Trial Profile

A Randomized Phase I/II Study to Evaluate Safety & Reactogenicity of Heat Stable Rotavirus Vaccine, in Healthy Adult; Followed by Evaluation of the Safety, Reactogenicity & Immunogenicity of a 3-dose Series in Infants Age 6-8 Weeks

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 09 May 2019

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At a glance

  • Drugs Rotavirus vaccine heat stable (Primary) ; Rotavirus W179-9 vaccine
  • Indications Rotavirus infections
  • Focus Adverse reactions; First in man
  • Sponsors MSD Wellcome Trust Hilleman Laboratories

Most Recent Events

  • 16 Aug 2017 Status changed from active, no longer recruiting to completed.
  • 23 Feb 2017 Planned End Date changed from 1 Feb 2017 to 1 May 2017.
  • 23 Feb 2017 Planned primary completion date changed from 1 Sep 2016 to 1 Mar 2017.

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