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Rotavirus vaccine - GlaxoSmithKline

Drug Profile

Rotavirus vaccine - GlaxoSmithKline

Alternative Names: 89-12; GSK 444563; GSK Biologicals' liquid human rotavirus vaccine 444563; GSK rotavirus vaccine 444563; GSK vaccine 444563; HRV Liquid - GlaxoSmithKline; HRV Lyophilized - GlaxoSmithKline; Liq PCV-free HRV; RIX-4414; Rotarix; Rotavirus vaccine - AVANT Immunotherapeutics/GlaxoSmithKline; Rotavirus vaccine 444563 - GlaxoSmithKline; SB-444563

Latest Information Update: 05 Nov 2023

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At a glance

  • Originator AVANT Immunotherapeutics; Cincinnati Childrens Hospital Medical Center
  • Developer GlaxoSmithKline; GSK; Japan Vaccine
  • Class Attenuated vaccines; Rotavirus vaccines
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No

Highest Development Phases

  • Marketed Rotavirus infections
  • Phase III Gastroenteritis

Most Recent Events

  • 01 Sep 2023 Phase-III clinical trials in Gastroenteritis (In infants, In volunteers) in China (PO) (NCT06025695)
  • 08 Jun 2023 GlaxoSmithKline initiated a phase III trial (In volunteers, In adolescents, In children, In infants, In neonates) in China (EudraCT2022-000708-36)
  • 17 May 2023 GlaxoSmithKline plans a phase III trial (In volunteers, In infants, In neonates, Prevention) (PO, Suspension) in China (EudraCT2020-000972-38)
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