An Observer-blind Study to Assess the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Pregnant Women and Infants Born to Vaccinated Mothers

Trial Profile

An Observer-blind Study to Assess the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Pregnant Women and Infants Born to Vaccinated Mothers

Withdrawn prior to enrolment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

Latest Information Update: 13 Oct 2017

At a glance

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

    • 10 Aug 2017 Last checked against Eudra record.
    • 08 Aug 2017 Status changed from recruiting to withdrawn prior to enrolment due to instability of the PreF antigen during manufacturing. No safety concern has been identified in past or ongoing studies
    • 17 Jul 2017 Status changed from not yet recruiting to recruiting.
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