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NCT04732871 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
A Phase 3 study of Respiratory Syncytial Virus Infections, sponsored by GlaxoSmithKline.
- Active
- Registry status
- Phase 3
- Development phase
- 1,720
- Enrollment target
- 20
- Study locations
NCT04732871: Active Phase 3 study of Respiratory Syncytial Virus Infections, sponsored by GlaxoSmithKline.
NCT04732871 is a Phase 3 study of Respiratory Syncytial Virus Infections that is active but no longer recruiting, run by GlaxoSmithKline. The registered enrollment target is 1,720 participants, above the 1,009-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (70% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04732871, a Phase 3 study of Respiratory Syncytial Virus Infections, is active but no longer recruiting, sponsored by GlaxoSmithKline.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,720 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the safety, reactogenicity, immunogenicity and long-term persistence of immune response up to 5 years following a single dose vaccination of GSK's investigational vaccine RSVPreF3 OA, in adults aged 60 years and above. The study will also evaluate the immunogenicity, safety and reactogenicity of additional vaccine doses given according to different revaccination schedules.
Primary Outcome
RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
Conditions Studied
Interventions
- BIOLOGICAL RSVPreF3 OA investigational vaccine
Study Locations (20)
Florida
- GSK Investigational Site - Coral Gables
- GSK Investigational Site - Fort Myers
- GSK Investigational Site - Sarasota
- GSK Investigational Site - The Villages
California
- GSK Investigational Site - Riverside
- GSK Investigational Site - San Diego
South Carolina
- GSK Investigational Site - Mt. Pleasant
- GSK Investigational Site - Spartanburg
Other
- GSK Investigational Site - Espoo
- GSK Investigational Site - Helsinki
Alabama
- GSK Investigational Site - Mobile
Arizona
- GSK Investigational Site - Phoenix
Indiana
- GSK Investigational Site - Evansville
Kansas
- GSK Investigational Site - Wichita
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,720 participants |
| Start Date | 2021-02-15 |
| Est. Completion | 2027-02-19 |
| Phase | Phase 3 |
What the registry record for NCT04732871 still lists
NCT04732871 is an interventional study that assigns participants to a tested intervention. Its 1,720 participants enrollment target places it among the larger protocols in the corpus, above the 1,009-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (70% higher).
The record links to 1 condition, with Respiratory Syncytial Virus Infections appearing as the primary indexed condition, and to 1 intervention - of which RSVPreF3 OA investigational vaccine is the first listed.
NCT04732871 names 20 study sites across 14 states, led by Florida, California, South Carolina.
Frequently Asked Questions
What is clinical trial NCT04732871 about?
NCT04732871 is a clinical study titled "Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above". The purpose of this study is to assess the safety, reactogenicity, immunogenicity and long-term persistence of immune response up to 5 years following a single dose vaccination of GSK's investigational vaccine RSVPreF3 OA, in adults aged 60 years and above. The study will also evaluate the immunogen...
What is the current status of trial NCT04732871?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,720 participants. The study started on 2021-02-15. Estimated completion is 2027-02-19.
What conditions does trial NCT04732871 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus Infections.
What interventions are being tested in trial NCT04732871?
The interventions under investigation include: RSVPreF3 OA investigational vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04732871?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04732871 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Indiana. 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 NCT04732871's enrollment target sits among peer trials
1,720 3rd of 21 higher than 19 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children
RECRUITING · Phase 3
-
An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study
ACTIVE NOT RECRUITING · Phase 3
-
A Study of 3 Lots of an Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Adults Aged 60 Years and Above
COMPLETED · 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
COMPLETED · Phase 3
-
A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults
COMPLETED · Phase 3
-
A Phase III Study to Assess the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone or Co-administered With GSK's Influenza D-QIV Vaccine in Healthy Non-pregnant Women.
COMPLETED · Phase 3
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