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A Phase II, Randomised, Observer-blind, Placebo Controlled Multi-country Study to Assess the Safety, Reactogenicity and Immunogenicity of a Single Intramuscular Dose of GSK Biologicals' Investigational RSV Maternal Unadjuvanted Vaccine (GSK3888550A), in Healthy Pregnant Women Aged 18 to 40 Years and Infants Born to Vaccinated Mothers

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A Phase II, Randomised, Observer-blind, Placebo Controlled Multi-country Study to Assess the Safety, Reactogenicity and Immunogenicity of a Single Intramuscular Dose of GSK Biologicals' Investigational RSV Maternal Unadjuvanted Vaccine (GSK3888550A), in Healthy Pregnant Women Aged 18 to 40 Years and Infants Born to Vaccinated Mothers

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Feb 2023

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At a glance

  • Drugs GSK-3888550A (Primary)
  • Indications Respiratory syncytial virus infections
  • Focus Adverse reactions; Pharmacodynamics
  • Acronyms RSV MAT-004
  • Sponsors GlaxoSmithKline; GlaxoSmithKline Biologicals; GSK

    • Most Recent Events

    • 01 Feb 2023 Results of a phase 2 randomized trial assessing Safety and immunogenicity of an investigational respiratory syncytial virus vaccine (RSVPreF3) in mothers and their infants published in the Journal of Infectious Diseases
    • 27 Jul 2021 Status changed from active, no longer recruiting to completed.
    • 25 Jun 2021 This trial has been completed in France, according to European Clinical Trials Database record.

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