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NCT05705440 · ClinicalTrials.gov registry record · Phase 3
A Follow-up Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous RSV MAT Studies During Any Pregnancy Conceived Post Vaccination/Control
A Phase 3 study of Respiratory Syncytial Virus Infections, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,855
- Enrollment target
- 20
- Study locations
NCT05705440: Completed Phase 3 study of Respiratory Syncytial Virus Infections, sponsored by GlaxoSmithKline.
NCT05705440 is a Phase 3 study of Respiratory Syncytial Virus Infections that has completed, run by GlaxoSmithKline. The registered enrollment target is 3,855 participants, above the 908-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (325% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05705440, a Phase 3 study of Respiratory Syncytial Virus Infections, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,855 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this follow-up study was to describe the safety in subsequent pregnancies in participants who were previously administered the RSVPreF3 maternal vaccine or control during any prior RSV MAT study. The study participants enrolled in this follow-up study received RSVPreF3 maternal vaccination (any dose) or controls during the following prior RSV MAT studies: RSV MAT-001 (NCT03674177), RSV MAT-004 (NCT04126213), RSV MAT-010 (NCT05045144), RSV MAT-011 (NCT04138056), RSV MAT-009 (NCT04605159), RSV MAT-012 (NCT04980391) and RSV MAT-039 (NCT05169905). No intervention was administered in this study. The exposure was the intervention (either RSVPreF3 vaccine or control) received by the study participants in the abovementioned prior RSV MAT studies.
Primary Outcome
Assessed pregnancy outcomes were live infant with no apparent congenital anomaly; spontaneous abortion with no apparent congenital anomaly; ectopic pregnancy; elective termination with no apparent congenital anomaly; live infant with congenital anomaly, and stillbirth with congenital anomaly. Due to the character limit, further description is added here instead of Analysis population description field: 1 participant in the Control group - Mother was excluded from this outcome's analysis as the g
Conditions Studied
Interventions
- OTHER Control
- BIOLOGICAL RSVPreF3 vaccine
Study Locations (20)
Texas
- GSK Investigational Site - Austin
- GSK Investigational Site - Fort Worth
- GSK Investigational Site - Houston
- GSK Investigational Site - Keller
Arizona
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Tucson
California
- GSK Investigational Site - Burbank
- GSK Investigational Site - Los Angeles
Idaho
- GSK Investigational Site - Nampa
- GSK Investigational Site - Nampa
Louisiana
- GSK Investigational Site - Covington
- GSK Investigational Site - Slidell
Michigan
- GSK Investigational Site - Detroit
- GSK Investigational Site - Saginaw
Alabama
- GSK Investigational Site - Mobile
Mississippi
- GSK Investigational Site - Biloxi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,855 participants |
| Start Date | 2023-02-07 |
| Est. Completion | 2025-01-15 |
| Phase | Phase 3 |
What the finished NCT05705440 record still lists
NCT05705440 is an interventional study that assigns participants to a tested intervention. Its 3,855 participants enrollment target places it among the larger protocols in the corpus, above the 908-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (325% higher).
The record links to 1 condition, with Respiratory Syncytial Virus Infections appearing as the primary indexed condition, and to 2 interventions - of which Control is the first listed.
NCT05705440 names 20 study sites across 12 states, led by Texas, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT05705440 about?
NCT05705440 is a clinical study titled "A Follow-up Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous RSV MAT Studies During Any Pregnancy Conceived Post Vaccination/Control". The purpose of this follow-up study was to describe the safety in subsequent pregnancies in participants who were previously administered the RSVPreF3 maternal vaccine or control during any prior RSV MAT study. The study participants enrolled in this follow-up study received RSVPreF3 maternal vacci...
What is the current status of trial NCT05705440?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,855 participants. The study started on 2023-02-07. Estimated completion is 2025-01-15.
What conditions does trial NCT05705440 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus Infections.
What interventions are being tested in trial NCT05705440?
The interventions under investigation include: Control (OTHER), RSVPreF3 vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05705440?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05705440 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Idaho, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Respiratory Syncytial Virus Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05705440's enrollment target sits among peer trials
3,855 2nd of 21 the highest of 21 other Respiratory Syncytial Virus Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Respiratory Syncytial Virus Infections 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.
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