Study to Evaluate the Efficacy, Immunogenicity, and Safety of RSVpreF in Adults.
Public ClinicalTrials.gov record NCT05035212. 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 STUDY TO EVALUATE THE EFFICACY, IMMUNOGENICITY, AND SAFETY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Efficacy Study: This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of a single dose of RSVpreF in the prevention of LRTI-RSV in adults: * At a dose of 120µg. * In adults 60 years of age and older. * The duration of the study for each participant will be up to approximately 24 months. * The study will be conducted in the United States, Canada, Netherlands, Finland, Argentina, Japan and South Africa. Substudy A: This study is an extension of the efficacy study and was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 2 years: * At a dose of 120µg (as studied in the Phase 3 Efficacy Study) * Blood samples will be collected for antibody testing. * The duration of the study for each participant will be up to approximately 18 months. * The study will be conducted in the United States and Argentina. Substudy B: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 1 year: * At a dose of 120µg (as studied in the Phase 3 Efficacy Study) * Blood samples will be collected for antibody testing. * The duration of the study for each participant will be up to approximately 18 months. * The study will be conducted in Argentina. Substudy C: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of either 3 or 4 years: * At a dose of 120µg (as studied in the Phase 3 Efficacy Study) * Participants will receive either placebo or a second dose of RSVpreF approximately 3 or 4 years after receiving the initial dose of RSVpreF in the main efficacy study. * Blood samples will be collected for antibody testing. * The duration of the study for each participant will be up to approximately 24 months. * The study will be conducted in the United States and Canada.
Study identification
- NCT ID
- NCT05035212
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 38,861 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
- Aug 31, 2021 (Actual)
- Primary completion
- Jan 18, 2027 (Estimated)
- Completion
- Jan 18, 2027 (Estimated)
- Last update posted
- Jan 28, 2026
2021 – 2027
United States locations
- U.S. sites
- 176
- U.S. states
- 34
- U.S. cities
- 122
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Vincent's Birmingham (Pharmacy) | Birmingham | Alabama | 35205 | — |
| St. Vincent's Birmingham | Birmingham | Alabama | 35205 | — |
| Medical Affiliated Research Center | Huntsville | Alabama | 35801 | — |
| Lenzmeier Family Medicine / Avacare | Glendale | Arizona | 85308 | — |
| Phoenix Clinical LLC | Phoenix | Arizona | 85014 | — |
| HOPE Research Institute | Phoenix | Arizona | 85018 | — |
| The Pain Center of Arizona | Phoenix | Arizona | 85018 | — |
| HOPE Research Institute | Phoenix | Arizona | 85023 | — |
| Cognitive Clinical Trials, LLC | Phoenix | Arizona | 85044 | — |
| Headlands Research - Scottsdale | Scottsdale | Arizona | 85260 | — |
| Alliance for Multispecialty Research, LLC | Tempe | Arizona | 85281 | — |
| HOPE Research Institute | Tempe | Arizona | 85284 | — |
| Noble Clinical Research | Tucson | Arizona | 85704 | — |
| The Institute for Liver Health dba Arizona Clinical Trials | Tucson | Arizona | 85712 | — |
| Hope Clinical Research | Canoga Park | California | 91303 | — |
| eStudySite | Chula Vista | California | 91911 | — |
| Benchmark Research | Colton | California | 92324 | — |
| West Coast Research | Dublin | California | 94568 | — |
| Marvel Clinical Research 002, LLC | Huntington Beach | California | 92647 | — |
| Chemidox Clinical Trials | Lancaster | California | 93534 | — |
| Ark Clinical Research | Long Beach | California | 90815 | — |
| Downtown L.A. Research Center, Inc. | Los Angeles | California | 90017 | — |
| Velocity Clinical Research, North Hollywood | North Hollywood | California | 91606 | — |
| Clinica mi Salud by Focil Med | Oxnard | California | 93030 | — |
| De Silva Medical Inc | Palmdale | California | 93551 | — |
| Empire Clinical Research | Pomona | California | 91767 | — |
| Paradigm Clinical Research Center | Redding | California | 96001 | — |
| Artemis Institute for Clinical Research | Riverside | California | 92503 | — |
| Benchmark Research | Sacramento | California | 95864 | — |
| Artemis Institute for Clinical Research | San Diego | California | 92123 | — |
| California Research Foundation | San Diego | California | 92123 | — |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | — |
| Lynn Institute of Denver | Aurora | Colorado | 80012 | — |
| Tekton Research LLC | Longmont | Colorado | 80501 | — |
| Clinical Research Consulting | Milford | Connecticut | 06460 | — |
| Stamford Therapeutics Consortium | Stamford | Connecticut | 06905 | — |
| JEM Research Institute | Atlantis | Florida | 33462 | — |
| IDEAL Clinical Research | Aventura | Florida | 33180 | — |
| Innovative Research of West Florida | Clearwater | Florida | 33756 | — |
| Invictus Clinical Research Group, LLC | Coconut Creek | Florida | 33073 | — |
| Nature Coast Clinical Research | Crystal River | Florida | 34429 | — |
| Universal Axon Clinical Research, LLC (Administrative) | Doral | Florida | 33166 | — |
| Indago Research & Health Center, Inc | Hialeah | Florida | 33012 | — |
| Doral Medical Research, LLC | Hialeah | Florida | 33016 | — |
| M3 Wake Research - Lake City | Lake City | Florida | 32055 | — |
| Optimus U Corporation | Miami | Florida | 33125 | — |
| Advance Medical Research Center | Miami | Florida | 33135 | — |
| Flourish Research - Miami, LLC | Miami | Florida | 33135 | — |
| Optimus U Corporation | Miami | Florida | 33135 | — |
| Next Phase Research Alliance | Miami | Florida | 33144 | — |
| New Horizon Research Center | Miami | Florida | 33165 | — |
| De La Cruz Research Center, LLC | Miami | Florida | 33184 | — |
| Global Health Research Center, Inc. | Miami Lakes | Florida | 33016 | — |
| Headlands Research Orlando | Orlando | Florida | 32819 | — |
| Pines Care Research Center, LLC | Pembroke Pines | Florida | 33024 | — |
| IDEAL Clinical Research | Pembroke Pines | Florida | 33026 | — |
| DBC Research USA | Pembroke Pines | Florida | 33029 | — |
| Headlands Research Sarasota | Sarasota | Florida | 34243 | — |
| Precision Clinical Research | Sunrise | Florida | 33351 | — |
| Clinical Site Partners, LLC dba Flourish Research | Winter Park | Florida | 32789 | — |
| Conquest Research | Winter Park | Florida | 32789 | — |
| Javara - Privia Medical Group Georgia - Albany | Albany | Georgia | 31707 | — |
| Coastal Heritage Clinical Research | Hinesville | Georgia | 31313 | — |
| Javara - Privia Medical Group Georgia - Savannah | Savannah | Georgia | 31406 | — |
| Velocity Clinical Research, Savannah | Savannah | Georgia | 31406 | — |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | — |
| Javara Inc. | Thomasville | Georgia | 31792 | — |
| Snake River Research, PLLC | Idaho Falls | Idaho | 83404 | — |
| Solaris Clinical Research | Meridian | Idaho | 83646 | — |
| Great Lakes Clinical Trials, LLC dba Flourish Research | Chicago | Illinois | 60640 | — |
| DM Clinical Research | Melrose Park | Illinois | 60160 | — |
| Affinity Health Corp | Oak Brook | Illinois | 60523 | — |
| Accellacare - DuPage | Oak Lawn | Illinois | 60453 | — |
| MOC Research | Mishawaka | Indiana | 46544 | — |
| Velocity Clinical Research Valparaiso | Valparaiso | Indiana | 46383 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Meridian Clinical Research, LLC | Sioux City | Iowa | 51106 | — |
| AMR Clinical | Lexington | Kentucky | 40509 | — |
| Ochsner Clinic Foundation | Kenner | Louisiana | 70065 | — |
| Ochsner Medical Center - Kenner | Kenner | Louisiana | 70065 | — |
| Velocity Clinical Research, Metairie | Metairie | Louisiana | 70006 | — |
| Velocity Clinical Research, Rockville | Rockville | Maryland | 20854 | — |
| ActivMed Practices & Research, LLC | Beverly | Massachusetts | 01915 | — |
| ActivMed Practices & Research, LLC | Methuen | Massachusetts | 01844 | — |
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | 01655 | — |
| Michigan Center of Medical Research (MICHMER) | Farmington Hills | Michigan | 48334 | — |
| Ascension St. John Hospital Vaccine Research Unit | Grosse Pointe Woods | Michigan | 48236 | — |
| Oakland Medical Research | Troy | Michigan | 48085 | — |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division | Troy | Michigan | 48098 | — |
| Saint Louis University | St Louis | Missouri | 63104 | — |
| Sundance Clinical Research | St Louis | Missouri | 63141 | — |
| Skyline Medical Center, PC/CCT Research | Elkhorn | Nebraska | 68022 | — |
| Quality Clinical Research | Omaha | Nebraska | 68114 | — |
| Wr-Crcn, Llc. | Las Vegas | Nevada | 89106 | — |
| Alliance for Multispecialty Research, LLC | Las Vegas | Nevada | 89119 | — |
| Las Vegas Clinical Trials | North Las Vegas | Nevada | 89030 | — |
| ActivMed Practices and Research, LLC. | Portsmouth | New Hampshire | 03801 | — |
| South Jersey Infectious Disease | Somers Point | New Jersey | 08244 | — |
| IMA Clinical Research Warren | Warren Township | New Jersey | 07059 | — |
| Velocity Clinical Research, Binghamton | Binghamton | New York | 13905 | — |
| Drug Trials America | Hartsdale | New York | 10530 | — |
| Corning Center for Clinical Research | Horseheads | New York | 14845 | — |
| Rochester Clinical Research, LLC | Rochester | New York | 14609 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| CHEAR Center LLC | The Bronx | New York | 10455 | — |
| Velocity Clinical Research, Vestal | Vestal | New York | 13850 | — |
| Atrium Health - Strive Vaccine Research Clinic | Charlotte | North Carolina | 28207 | — |
| Tryon Medical Partners, PLLC | Charlotte | North Carolina | 28210 | — |
| Accellacare - Charlotte | Charlotte | North Carolina | 28211 | — |
| Sensenbrenner Primary Care Research Office | Charlotte | North Carolina | 28277 | — |
| Accellacare - Wilmington - 1917 Tradd Court | Wilmington | North Carolina | 28401 | — |
| Accellacare - Wilmington | Wilmington | North Carolina | 28401 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Velocity Clinical Research, Cincinnati, Mt. Auburn | Cincinnati | Ohio | 45219 | — |
| Velocity Clinical Research - Cincinnati | Cincinnati | Ohio | 45242 | — |
| Velocity Clinical Research, Springdale | Cincinnati | Ohio | 45246 | — |
| Centricity Research Columbus Ohio Multispecialty | Columbus | Ohio | 43213 | — |
| Tekton Research, LLC. | Edmond | Oklahoma | 73013 | — |
| Tekton Research, Inc | Yukon | Oklahoma | 73099 | — |
| The Corvallis Clinic, PC | Corvallis | Oregon | 97330 | — |
| Velocity Clinical Research, Grants Pass | Grants Pass | Oregon | 97527 | — |
| Velocity Clinical Research, Medford | Medford | Oregon | 97504 | — |
| Summit Headlands, LLC | Portland | Oregon | 97210 | — |
| Kaiser Permanente Northwest Center for Health Research | Portland | Oregon | 97227 | — |
| Capital Area Research, LLC | Camp Hill | Pennsylvania | 17011 | — |
| Central Erie Primary Care | Erie | Pennsylvania | 16508 | — |
| Penn Prevention Unit | Philadelphia | Pennsylvania | 19104 | — |
| Velocity Clinical Research, Providence | East Greenwich | Rhode Island | 02818 | — |
| AMR Clinical | Knoxville | Tennessee | 37909 | — |
| Accellacare US Inc., d/b/a Accellacare of Knoxville | Knoxville | Tennessee | 37912 | — |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | — |
| Benchmark Research | Austin | Texas | 78705 | — |
| Innovo Research - Austin Regional Clinic | Austin | Texas | 78726 | — |
| Tekton Research, LLC. | Austin | Texas | 78745 | — |
| Tekton Research, LLC. | Beaumont | Texas | 77706 | — |
| Javara - Privia Medical Group Gulf Coast - The Woodlands HWH | Conroe | Texas | 77384 | — |
| North Texas Infectious Diseases Consultants, P.A | Dallas | Texas | 75246 | — |
| Benchmark Research | Fort Worth | Texas | 76135 | — |
| Texas Health Family Care | Fort Worth | Texas | 76135 | — |
| Allure Health at Mt. Olympus Medical Research | Friendswood | Texas | 77546 | — |
| Hany H. Ahmed, MD | Houston | Texas | 77008 | — |
| Helios Clinical Research - HOU | Houston | Texas | 77008 | — |
| HG Pediatrics | Houston | Texas | 77008 | — |
| Trio Clinical Trials, LLC | Houston | Texas | 77008 | — |
| Van Tran Family Practice | Houston | Texas | 77008 | — |
| Ventavia Research Group, LLC | Houston | Texas | 77008 | — |
| Centex Studies | Houston | Texas | 77058 | — |
| DM Clinical Research - Cy Fair | Houston | Texas | 77065 | — |
| DM Clinical Research- Cyfair | Houston | Texas | 77065 | — |
| DM Clinical Research - Bellaire | Houston | Texas | 77081 | — |
| Centex Studies | Houston | Texas | 77090 | — |
| DM Clinical Research - Humble | Humble | Texas | 77338 | — |
| DM Clinical Research, Martin Diagnostic Clinic | Humble | Texas | 77338 | — |
| Milton Haber, M.D. | Laredo | Texas | 78041 | — |
| Milton Haber, MD | Laredo | Texas | 78041 | — |
| SMS Clinical Research | Mesquite | Texas | 75149 | — |
| Sun Research Institute | San Antonio | Texas | 78215 | — |
| Clinical Trials of Texas, LLC dba Flourish Research | San Antonio | Texas | 78229 | — |
| Clinical Trials of Texas, LLC | San Antonio | Texas | 78229 | — |
| Dynamed Clinical Research, LP d/b/a DM Clinical Research | Sugar Land | Texas | 77478 | — |
| Javara Inc. | Sugar Land | Texas | 77478 | — |
| Mt Olympus Medical Research | Sugar Land | Texas | 77479 | — |
| Dynamed Clinical Research, LP d/b/a DM Clinical Research | Tomball | Texas | 77375 | — |
| J. Lewis Research, Inc. / Foothill Family Clinic Draper | Draper | Utah | 84020 | — |
| Tanner Clinic | Layton | Utah | 84041 | — |
| J. Lewis Research, Inc. / Jordan River Family Medicine | South Jordan | Utah | 84095 | — |
| Velocity Clinical Research, Salt Lake City | West Jordan | Utah | 84088 | — |
| Centricity Research Suffolk Primary Care | Suffolk | Virginia | 23435 | — |
| Virginia Gastroenterology Clinical Research | Suffolk | Virginia | 23435 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
| Sound Medical Research | Port Orchard | Washington | 98366 | — |
| MultiCare Institute for Research & Innovation | Tacoma | Washington | 98405 | — |
| MultiCare Medical Group | Tacoma | Washington | 98405 | — |
| Central Washington Health Services Association d/b/a Confluence Health | Wenatchee | Washington | 98801 | — |
| Research Building | Wenatchee | Washington | 98801 | — |
| Allegiance Research Specialists, LLC | Wauwatosa | Wisconsin | 53226 | — |
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 87 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05035212, 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 Jan 28, 2026 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05035212 live on ClinicalTrials.gov.