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NCT04980391 · ClinicalTrials.gov registry record · Phase 3
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 3 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 3
- Development phase
- 384
- Enrollment target
NCT04980391: Clinical Trial Phase 3 study, sponsored by GlaxoSmithKline.
NCT04980391 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 384 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04980391, a Phase 3 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 384 participants
- Enrollment target
Study 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.
Primary Outcome
Assessed solicited administration site events included erythema, pain and swelling. Any pain = occurrence of the symptom regardless of intensity grade. Any erythema and swelling = symptom reported with a surface diameter greater than or equal to 20 millimeters.
Interventions
- DRUG Placebo
- BIOLOGICAL RSV MAT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 384 participants |
| Start Date | 2021-08-03 |
| Est. Completion | 2023-05-30 |
| Phase | Phase 3 |
Why NCT04980391 stopped before completion
NCT04980391 is an interventional study that assigns participants to a tested intervention. The registered 384 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04980391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04980391 about?
NCT04980391 is a clinical study titled "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". 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)...
What is the current status of trial NCT04980391?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 384 participants. The study started on 2021-08-03. Estimated completion is 2023-05-30.
What interventions are being tested in trial NCT04980391?
The interventions under investigation include: Placebo (DRUG), RSV MAT (BIOLOGICAL).
Who is sponsoring clinical trial NCT04980391?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04980391's enrollment target sits among peer trials
384 975th of 2000 higher than 1,025 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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