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A Phase 3 Double-blind, Randomized, Active Comparator-controlled, Group-sequential, Multinational Trial to Assess the Safety, Immunogenicity and Efficacy of a Trivalent Rotavirus P2-VP8 Subunit Vaccine in Prevention of Severe Rotavirus Gastroenteritis in Healthy Infants

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A Phase 3 Double-blind, Randomized, Active Comparator-controlled, Group-sequential, Multinational Trial to Assess the Safety, Immunogenicity and Efficacy of a Trivalent Rotavirus P2-VP8 Subunit Vaccine in Prevention of Severe Rotavirus Gastroenteritis in Healthy Infants

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Apr 2021

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At a glance

  • Drugs Rotavirus vaccine PATH (Primary) ; RIX 4414
  • Indications Gastroenteritis; Rotavirus infections
  • Focus Adverse reactions; Therapeutic Use

    • Most Recent Events

    • 08 Apr 2021 Planned End Date changed from 15 Dec 2024 to 15 Dec 2025.
    • 08 Apr 2021 Planned primary completion date changed from 15 Aug 2024 to 15 Dec 2025.
    • 08 Apr 2021 Status changed from suspended to recruiting.

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