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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 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 384 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04980391
The ClinicalTrials.gov registry entry for NCT04980391 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 384 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04980391 reports 0 study locations.
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.
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