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NCT05169905 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine in Healthy Non-pregnant Females From 9 to 49 Years of Age
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 9
- Enrollment target
NCT05169905 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 9 participants.
The verdict
NCT05169905, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 9 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the reactogenicity, safety and immune response of a single intramuscular dose of the respiratory syncytial virus maternal (RSV MAT) vaccine in healthy non-pregnant girls 9-17 years of age (YOA) compared to non-pregnant adult women 18-49 YOA. The combined reduced-antigen-content diphtheria, tetanus and acellular pertussis (dTpa) vaccine was planned to be used as an active control for safety and reactogenicity evaluation. Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in this study. Enrolled study participants were monitored as part of the study until study completion.
Interventions
- COMBINATION_PRODUCT RSV MAT vaccine
- COMBINATION_PRODUCT dTpa vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2022-02-02 |
| Est. Completion | 2022-08-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05169905
The ClinicalTrials.gov registry entry for NCT05169905 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 9 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 RSV MAT vaccine is the first listed.
NCT05169905 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05169905 about?
NCT05169905 is a clinical study titled "A Study to Evaluate the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine in Healthy Non-pregnant Females From 9 to 49 Years of Age". The purpose of this study was to evaluate the reactogenicity, safety and immune response of a single intramuscular dose of the respiratory syncytial virus maternal (RSV MAT) vaccine in healthy non-pregnant girls 9-17 years of age (YOA) compared to non-pregnant adult women 18-49 YOA. The combined red...
What is the current status of trial NCT05169905?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 9 participants. The study started on 2022-02-02. Estimated completion is 2022-08-03.
What interventions are being tested in trial NCT05169905?
The interventions under investigation include: RSV MAT vaccine (COMBINATION_PRODUCT), dTpa vaccine (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05169905?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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