Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
Public ClinicalTrials.gov record NCT04886596. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Placebo-controlled, Observer-blind, Multi-country Study to Demonstrate the Efficacy of a Single Dose and Annual Revaccination Doses of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Above
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate the efficacy of the RSVPreF3 OA investigational vaccine in preventing Lower Respiratory Tract Disease (LRTD) caused by RSV in adults ≥60 years of age following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses in Northern Hemisphere (NH) and in Southern Hemisphere (SH). This study will also assess if the vaccine is safe and induces an immune response.
Study identification
- NCT ID
- NCT04886596
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 26,675 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 60 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 25, 2021 (Actual)
- Primary completion
- Apr 11, 2022 (Actual)
- Completion
- May 31, 2024 (Actual)
- Last update posted
- Jul 31, 2025
2021 – 2024
United States locations
- U.S. sites
- 60
- U.S. states
- 23
- U.S. cities
- 57
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35205 | — |
| GSK Investigational Site | Birmingham | Alabama | 35211 | — |
| GSK Investigational Site | Huntsville | Alabama | 35802 | — |
| GSK Investigational Site | Phoenix | Arizona | 85306 | — |
| GSK Investigational Site | Tucson | Arizona | 85741 | — |
| GSK Investigational Site | Cerritos | California | 90703 | — |
| GSK Investigational Site | Laguna Hills | California | 92653 | — |
| GSK Investigational Site | Coral Gables | Florida | 33134 | — |
| GSK Investigational Site | Fort Myers | Florida | 33912 | — |
| GSK Investigational Site | Jacksonville | Florida | 32205 | — |
| GSK Investigational Site | Lake City | Florida | 32055 | — |
| GSK Investigational Site | Melbourne | Florida | 32934 | — |
| GSK Investigational Site | Miami | Florida | 33174 | — |
| GSK Investigational Site | Orlando | Florida | 32806 | — |
| GSK Investigational Site | Pinellas Park | Florida | 33781 | — |
| GSK Investigational Site | The Villages | Florida | 32162 | — |
| GSK Investigational Site | Weeki Wachee | Florida | 34607 | — |
| GSK Investigational Site | West Palm Beach | Florida | 33409 | — |
| GSK Investigational Site | Atlanta | Georgia | 30328 | — |
| GSK Investigational Site | Chicago | Illinois | 60602 | — |
| GSK Investigational Site | Evansville | Indiana | 47714 | — |
| GSK Investigational Site | Mishawaka | Indiana | 46544 | — |
| GSK Investigational Site | El Dorado | Kansas | 67042 | — |
| GSK Investigational Site | Newton | Kansas | 67114 | — |
| GSK Investigational Site | Wichita | Kansas | 67205 | — |
| GSK Investigational Site | Wichita | Kansas | 67207 | — |
| GSK Investigational Site | Lexington | Kentucky | 40509 | — |
| GSK Investigational Site | Rockville | Maryland | 20854 | — |
| GSK Investigational Site | Richfield | Minnesota | 55423 | — |
| GSK Investigational Site | Kansas City | Missouri | 64114 | — |
| GSK Investigational Site | St Louis | Missouri | 63141 | — |
| GSK Investigational Site | Omaha | Nebraska | 68134 | — |
| GSK Investigational Site | Henderson | Nevada | 89052 | — |
| GSK Investigational Site | Binghamton | New York | 31406 | — |
| GSK Investigational Site | Jamaica | New York | 10017 | — |
| GSK Investigational Site | Rochester | New York | 14609 | — |
| GSK Investigational Site | Hickory | North Carolina | 28601 | — |
| GSK Investigational Site | Rocky Mount | North Carolina | 27804 | — |
| GSK Investigational Site | Salisbury | North Carolina | 28144 | — |
| GSK Investigational Site | Statesville | North Carolina | 28117 | — |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | — |
| GSK Investigational Site | Akron | Ohio | 44311 | — |
| GSK Investigational Site | Centerville | Ohio | 45459 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45236 | — |
| GSK Investigational Site | Columbus | Ohio | 43212 | — |
| GSK Investigational Site | Erie | Pennsylvania | 16508 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15236 | — |
| GSK Investigational Site | Anderson | South Carolina | 29621 | — |
| GSK Investigational Site | Mt. Pleasant | South Carolina | 29405 | — |
| GSK Investigational Site | Knoxville | Tennessee | 37912 | — |
| GSK Investigational Site | Memphis | Tennessee | 38119 | — |
| GSK Investigational Site | Dallas | Texas | 75234 | — |
| GSK Investigational Site | Fort Worth | Texas | 76104 | — |
| GSK Investigational Site | Houston | Texas | 77008 | — |
| GSK Investigational Site | Houston | Texas | 77055 | — |
| GSK Investigational Site | Keller | Texas | 76248 | — |
| GSK Investigational Site | San Antonio | Texas | 78229 | — |
| GSK Investigational Site | Layton | Utah | 84041 | — |
| GSK Investigational Site | Murray | Utah | 84106 | — |
| GSK Investigational Site | Norfolk | Virginia | 23502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 217 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04886596, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 31, 2025 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04886596 live on ClinicalTrials.gov.