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NCT04605159 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 3
- Development phase
- 11,194
- Enrollment target
NCT04605159 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 11,194 participants.
The verdict
NCT04605159, a Phase 3 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 11,194 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the ability of a single dose of the investigational RSV Maternal vaccine, administered intramuscularly (IM) to pregnant women aged 18-49 years, in good general maternal health, in preventing medically assessed RSV associated Lower Respiratory Tract Illnesses (LRTIs) in infants born to vaccinated mothers. The study also evaluated the safety of the investigational RSV Maternal vaccine both in vaccinated mothers and in their corresponding infant. 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 | 11,194 participants |
| Start Date | 2020-11-20 |
| Est. Completion | 2023-06-14 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04605159
The ClinicalTrials.gov registry entry for NCT04605159 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 11,194 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.
NCT04605159 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04605159 about?
NCT04605159 is a clinical study titled "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". The purpose of this study was to evaluate the ability of a single dose of the investigational RSV Maternal vaccine, administered intramuscularly (IM) to pregnant women aged 18-49 years, in good general maternal health, in preventing medically assessed RSV associated Lower Respiratory Tract Illnesses...
What is the current status of trial NCT04605159?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 11,194 participants. The study started on 2020-11-20. Estimated completion is 2023-06-14.
What interventions are being tested in trial NCT04605159?
The interventions under investigation include: Placebo (DRUG), RSV MAT (BIOLOGICAL).
Who is sponsoring clinical trial NCT04605159?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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