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Immunogenicity and Safety Study of Two Formulations of GlaxoSmithKline (GSK) Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

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Trial Profile

Immunogenicity and Safety Study of Two Formulations of GlaxoSmithKline (GSK) Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Sep 2023

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At a glance

  • Drugs RIX 4414 (Primary)
  • Indications Rotavirus infections
  • Focus Pharmacodynamics; Registrational
  • Acronyms ROTA-081
  • Sponsors GlaxoSmithKline; GlaxoSmithKline Biologicals; GSK

    • Most Recent Events

    • 04 May 2020 Primary endpoint (Anti-RV IgA Antibody Concentrations in the PCV-free Liquid HRV Vaccine (Pooled HRV Liquid Group) and Lyophilised Control Group) has been met, as per Results published in the Journal of Infectious Diseases
    • 04 May 2020 Primary endpoint (Percentage of Seroconverted Subjects With RV Antibody Concentrations Above or Equal to Cut-off Value in Porcine Circovirus (PCV) -Free Liquid HRV Vaccine (Pooled HRV Liquid Group) and Control Group) has been met, as per Results published in the Journal of Infectious Diseases
    • 04 May 2020 Primary endpoint (Anti-Rota Virus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations in the Human Rotavirus (HRV) Liquid Formulation Groups (Liq_A, Liq_B and Liq_C)) has been met, as per Results published in the Journal of Infectious Diseases

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