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
Public ClinicalTrials.gov record NCT04980391. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04980391
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 384 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 15 Years to 49 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2, 2021
- Primary completion
- May 29, 2023
- Completion
- May 29, 2023
- Last update posted
- Apr 19, 2025
2021 – 2023
United States locations
- U.S. sites
- 16
- U.S. states
- 5
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35205 | — |
| GSK Investigational Site | Dothan | Alabama | 36305 | — |
| GSK Investigational Site | Mobile | Alabama | 36608 | — |
| GSK Investigational Site | Phoenix | Arizona | 85015 | — |
| GSK Investigational Site | Covington | Louisiana | 70433 | — |
| GSK Investigational Site | Lafayette | Louisiana | 70508 | — |
| GSK Investigational Site | Slidell | Louisiana | 70458 | — |
| GSK Investigational Site | Missoula | Montana | 59804 | — |
| GSK Investigational Site | Arlington | Texas | 76012 | — |
| GSK Investigational Site | Austin | Texas | 78705 | — |
| GSK Investigational Site | Fort Worth | Texas | 76104 | — |
| GSK Investigational Site | Grapevine | Texas | 76051 | — |
| GSK Investigational Site | Houston | Texas | 77008 | — |
| GSK Investigational Site | League City | Texas | 77573 | — |
| GSK Investigational Site | Plano | Texas | 75093 | — |
| GSK Investigational Site | Weatherford | Texas | 76086 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04980391, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 19, 2025 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04980391 live on ClinicalTrials.gov.