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A Phase III, Observer-blind, Randomized, Multi-country Study to Assess the Reactogenicity and Safety of the Porcine Circovirus (PCV) Free Liquid Formulation of GSK's Oral Live Attenuated Human Rotavirus (HRV) Vaccine as Compared to the Lyophilized Formulation of the GSK's HRV Vaccine, When Administered as a 2-dose Vaccination in Infants Starting at Age 6-12 Weeks

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Trial Profile

A Phase III, Observer-blind, Randomized, Multi-country Study to Assess the Reactogenicity and Safety of the Porcine Circovirus (PCV) Free Liquid Formulation of GSK's Oral Live Attenuated Human Rotavirus (HRV) Vaccine as Compared to the Lyophilized Formulation of the GSK's HRV Vaccine, When Administered as a 2-dose Vaccination in Infants Starting at Age 6-12 Weeks

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Sep 2023

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At a glance

  • Drugs RIX 4414 (Primary) ; Rotavirus vaccine
  • Indications Diarrhoea; Rotavirus infections
  • Focus Adverse reactions
  • Acronyms ROTA-096
  • Sponsors GlaxoSmithKline; GlaxoSmithKline Biologicals; GSK

    • Most Recent Events

    • 26 Feb 2022 Results of additional reactogenicity and safety data, published in the Vaccine
    • 15 Jan 2021 Status changed from active, no longer recruiting to completed.
    • 14 Feb 2020 Status changed from recruiting to active, no longer recruiting.

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