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A Phase I/II, randomised, observer-blind, controlled multi-country study to assess the safety, reactogenicity and immunogenicity of a single intramuscular dose of GSK Biologicals' investigational RSV vaccine (GSK3003891A), in healthy pregnant women aged 18 to 40 years and infants born to vaccinated mothers

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Trial Profile

A Phase I/II, randomised, observer-blind, controlled multi-country study to assess the safety, reactogenicity and immunogenicity of a single intramuscular dose of GSK Biologicals' investigational RSV vaccine (GSK3003891A), in healthy pregnant women aged 18 to 40 years and infants born to vaccinated mothers

Status: Withdrawn prior to enrolment
Phase of Trial: Phase I/II

Latest Information Update: 03 Jul 2023

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At a glance

  • Drugs GSK 3003891A (Primary)
  • Indications Respiratory syncytial virus infections
  • Focus Adverse reactions
  • Acronyms RSV F-004
  • Sponsors GlaxoSmithKline; GSK

    • Most Recent Events

    • 12 Oct 2018 Planned End Date changed from 13 Jul 2017 to 14 Jul 2017.
    • 12 Oct 2018 Planned primary completion date changed from 12 Jul 2017 to 14 Jul 2017.
    • 19 Jul 2018 Planned End Date changed from 25 Dec 2020 to 13 Jul 2017.

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