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

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

Withdrawn prior to enrolment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

Latest Information Update: 24 Jul 2018

At a glance

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

    • 24 Jul 2018 Last checked against European Clinical Trials Database record.
    • 19 Jul 2018 Planned End Date changed from 25 Dec 2020 to 13 Jul 2017.
    • 19 Jul 2018 Planned primary completion date changed from 20 Apr 2019 to 12 Jul 2017.
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