NCT04980391

A Study on the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine, in High Risk Pregnant Women Aged 15 to 49 Years and Infants Born to the Vaccinated Mothers

A Phase III, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Reactogenicity and Immune Response of a Single Intramuscular Dose of Unadjuvanted RSV Maternal Vaccine, in High Risk Pregnant Women Aged 15 to 49 Years and Infants Born to the Vaccinated Mothers

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 384 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 15 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to evaluate the safety, reactogenicity and immune response of a single intramuscular dose of the respiratory syncytial virus (RSV) maternal vaccine compared to placebo, when administered in the second or third trimester of pregnancy in women, 15 to 49 years of age (YOA), with high risk pregnancies and in the infants born to the vaccinated mothers. Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study. Ongoing study participants at that time continued to be monitored as part of the study.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	RSV MAT	Single dose of the RSV MAT vaccine reconstituted with NaCl solution, administered intramuscularly in the non-dominant arm, at Day 1.
DRUG	Placebo	Single dose of placebo, administered intramuscularly in the non-dominant arm, at Day 1.

Timeline

• Start date: 2021-08-03
• Primary completion: 2023-05-30
• Completion: 2023-05-30
• First posted: 2021-07-28
• Last updated: 2025-04-20
• Results posted: 2024-02-06

Locations

35 sites across 9 countries: United States, Brazil, Canada, Finland, India, Italy, Panama, South Africa, Spain

Regulatory

• FDA-regulated drug study