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A Phase III, observer-blind, randomized, multicenter study to evaluate immunogenicity, reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine circovirus (PCV)-free liquid as compared to GSK's Rotarix liquid, given in 2 doses in healthy Chinese infants starting at age 6-16 weeks

Trial Profile

A Phase III, observer-blind, randomized, multicenter study to evaluate immunogenicity, reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine circovirus (PCV)-free liquid as compared to GSK's Rotarix liquid, given in 2 doses in healthy Chinese infants starting at age 6-16 weeks

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 May 2025

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At a glance

  • Drugs RIX 4414 (Primary)
  • Indications Rotavirus infections
  • Focus Pharmacodynamics; Registrational
  • Acronyms ROTA-097
  • Sponsors GlaxoSmithKline Biologicals; GSK

Most Recent Events

  • 26 Oct 2024 Status changed from recruiting to completed.
  • 04 Mar 2024 Planned End Date changed from 1 Oct 2024 to 18 Nov 2024.
  • 04 Mar 2024 Planned primary completion date changed from 22 Apr 2024 to 19 Jun 2024.

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