# 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

> **NCT04605159** · PHASE3 · TERMINATED · sponsor: **GlaxoSmithKline** · enrollment: 11194 (actual)

## Conditions studied

- Respiratory Syncytial Virus Infections

## Interventions

- **BIOLOGICAL:** RSV MAT
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT04605159
- **Lead sponsor:** GlaxoSmithKline
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2020-11-20
- **Primary completion:** 2023-06-14
- **Final completion:** 2023-06-14
- **Target enrollment:** 11194 (ACTUAL)
- **Why stopped:** 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.
- **Last updated:** 2025-02-20


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04605159

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04605159, "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". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT04605159. Licensed CC0.

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