A Phase III Double-blind Study to Assess Safety and Efficacy of an RSV Maternal Unadjuvanted Vaccine, in Pregnant Women and Infants Born to Vaccinated Mothers (GRACE)

  • STATUS
    Not Recruiting
  • End date
    Feb 2, 2024
  • participants needed
    20000
  • sponsor
    GlaxoSmithKline
Updated on 18 April 2022
Accepts healthy volunteers

Summary

The purpose of this study is to evaluate the ability of a single dose of the investigational RSV Maternal vaccine, administered intramuscularly to pregnant women aged 18-49 years, in good general maternal health, in preventing medically assessed RSV associated Lower Respiratory Tract Illnesses (LRTIs) in infants born to vaccinated mothers. The study will also evaluate the safety of the investigational RSV Maternal vaccine both in vaccinated mothers and in their corresponding infant.

Details
Condition Respiratory Syncytial Virus Infections
Treatment Placebo, RSV MAT
Clinical Study IdentifierNCT04605159
SponsorGlaxoSmithKline
Last Modified on18 April 2022

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