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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: Clinical Trial Phase 3 study, sponsored by GlaxoSmithKline.
NCT04605159 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 11,194 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1352% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND a blood oxygen saturation by pulse oximetry (SpO2) lower than (\<) 95%, OR respiratory rate increase AND a confirmed RSV infection. An RSV-associated severe LRTI met the case definition of RSV-LRTI AND was additionally characterized by a SpO2 \<93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious. Medically assessed = the infant was evaluated by a
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 |
Why NCT04605159 stopped before completion
NCT04605159 is an interventional study that assigns participants to a tested intervention. Its 11,194 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1352% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04605159 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04605159's enrollment target sits among peer trials
11,194 22nd of 2000 higher than 1,979 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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