# 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

> **NCT04980391** · PHASE3 · TERMINATED · sponsor: **GlaxoSmithKline** · enrollment: 384 (actual)

## Conditions studied

- Respiratory Syncytial Virus Infections

## Interventions

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

## Key facts

- **NCT ID:** NCT04980391
- **Lead sponsor:** GlaxoSmithKline
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2021-08-03
- **Primary completion:** 2023-05-30
- **Final completion:** 2023-05-30
- **Target enrollment:** 384 (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:** 2025-04-20


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04980391

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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". Retrieved via AI Analytics 2026-06-03 from https://api.ai-analytics.org/clinical/NCT04980391. Licensed CC0.

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