ClinicalTrials.gov record
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age
ClinicalTrials.gov ID: NCT05085366
Public ClinicalTrials.gov record NCT05085366. 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, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main purpose of this study is to evaluate the efficacy of mRNA 1647 vaccine in CMV-seronegative female participants and to evaluate the safety and reactogenicity of mRNA-1647 vaccine in all participants. The purpose of the Phase 3 extension substudy is to extend the observation period of the main study and to assess the longer-term immunogenicity, efficacy, and safety of the mRNA-1647 vaccine against primary CMV infection in healthy females who were CMV-seronegative at Baseline of the mRNA-1647-P301 main study (including participants who remain CMV-seronegative upon entry into the extension substudy and participants who seroconverted during the main study). The extension substudy will also evaluate the immune persistence and safety of mRNA-1647 in a subset of female participants who were CMV-seropositive at Baseline of the main study. No interventional vaccine will be administered in the extension substudy.
Study identification
- NCT ID
- NCT05085366
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 7,454 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years to 40 Years
- Sex
- Female
- 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
- Oct 26, 2021 (Actual)
- Primary completion
- Nov 4, 2025 (Actual)
- Completion
- Nov 4, 2025 (Actual)
- Last update posted
- Dec 15, 2025
2021 – 2025
United States locations
- U.S. sites
- 181
- U.S. states
- 38
- U.S. cities
- 144
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Central Research Associates Inc | Birmingham | Alabama | 35205 | — |
| Accel Research Site - Achieve - Birmingham - ERN - PPDS | Birmingham | Alabama | 35216 | — |
| SEC Clinical Research LLC - Dothan - ClinEdge - PPDS | Dothan | Alabama | 36305 | — |
| Lakeview Clinical Research | Guntersville | Alabama | 35976 | — |
| Chandler Clinical Trials, LLC | Chandler | Arizona | 85224 | — |
| Arizona Clinical Trials | Mesa | Arizona | 85210 | — |
| Phoenix Clinical LLC | Phoenix | Arizona | 85014 | — |
| MedPharmics, LLC | Phoenix | Arizona | 85015-1105 | — |
| Hope Research Institute LLC | Phoenix | Arizona | 85018 | — |
| Hope Research Institute LLC | Phoenix | Arizona | 85023 | — |
| Epic Medical Research Arizona | Surprise | Arizona | 85378-9021 | — |
| Voyage Medical | Tempe | Arizona | 85282 | — |
| Hope Research Institute LLC | Tempe | Arizona | 85284 | — |
| Tucson Neuroscience Research - M3 WR - ERN - PPDS | Tucson | Arizona | 85710-6155 | — |
| The Institute for Liver Health-Tucson | Tucson | Arizona | 85712-4046 | — |
| Del Sol Research Management - ClinEdge - PPDS | Tucson | Arizona | 85715 | — |
| Noble Clinical Research | Tucson | Arizona | 86704 | — |
| Baptist Health Center for Clinical Research | Little Rock | Arkansas | 72205-6355 | — |
| Preferred Research Partners | Little Rock | Arkansas | 72211 | — |
| Applied Research Center of Arkansas - Clinedge - PPDS | Little Rock | Arkansas | 72212 | — |
| Velocity Clinical Research - Banning | Banning | California | 92220 | — |
| Velocity Clinical Research - Chula Vista | Chula Vista | California | 91911-6617 | — |
| Apex Research Group | Fair Oaks | California | 95628-2500 | — |
| Ascada Research LLC | Fullerton | California | 92835 | — |
| Paradigm Clinical Research Center | La Mesa | California | 91942 | — |
| Velocity Clinical Research - San Diego | La Mesa | California | 91942 | — |
| Long Beach Research Institute, LLC | Long Beach | California | 90805 | — |
| Long Beach Clinical Trials Services Inc. | Long Beach | California | 90806 | — |
| Catalina Research Institute LLC | Montclair | California | 91763 | — |
| Carbon Health- NoHo West Urgent Care and Primary Care | North Hollywood | California | 91606 | — |
| Empire Clinical Research | Pomona | California | 91767 | — |
| Paradigm Clinical Research Institute, Inc. - ClinEdge | Redding | California | 96001-0172 | — |
| Smart Cures Clinical Research | Rolling Hills Estates | California | 90274-7604 | — |
| Northern California Research Corp | Sacramento | California | 95821 | — |
| Womens Healthcare Research Corporation ERN PPDS | San Diego | California | 92111 | — |
| Care Access Research - Santa Clarita | Santa Clarita | California | 91321 | — |
| Stanford University School of Medicine | Stanford | California | 94305 | — |
| Clinical Trials Management Services, LLC | Thousand Oaks | California | 91360 | — |
| Bayview Research Group | Valley Village | California | 91607 | — |
| Next Level Clinical Trials | West Covina | California | 91730 | — |
| Care Access Research - Aurora | Aurora | Colorado | 80012 | — |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045-7144 | — |
| Paradigm Clinical Research Institute Inc - ClinEdge | Wheat Ridge | Colorado | 80033 | — |
| New England Research Associates LLC - ERN - PPDS | Bridgeport | Connecticut | 06606 | — |
| Clinical Research Consultants LLC | Milford | Connecticut | 06460-4647 | — |
| Emerson Clinical Research Institute LLC - Kennedy St | Washington D.C. | District of Columbia | 20011 | — |
| Invictus Clinical Research Group, LLC | Coconut Creek | Florida | 33073 | — |
| Luna Research LLC | Coral Gables | Florida | 33134-2220 | — |
| Herco Medical and Research Center, Inc. | Coral Gables | Florida | 33134-2537 | — |
| Precision Clinical Research, LLC | Coral Springs | Florida | 33065 | — |
| Universal Axon Clinical Research | Doral | Florida | 33166 | — |
| Unique Clinical Trials, LLC | Doral | Florida | 33172-1507 | — |
| Velocity Clinical Research, New Smyrna Beach | Edgewater | Florida | 32132-2720 | — |
| Indago Research and Health Center | Hialeah | Florida | 33012-4174 | — |
| Best Quality Research, Inc | Hialeah | Florida | 33016 | — |
| Florida International Medical Research | Miami | Florida | 33155-2164 | — |
| Miami Clinical Research | Miami | Florida | 33155 | — |
| Spotlight Research Center, LLC | Miami | Florida | 33176 | — |
| Floridian Clinical Research - ClinEdge - PPDS | Miami Lakes | Florida | 33016 | — |
| Ormond Beach Clinical Research | Ormond Beach | Florida | 32174-8196 | — |
| Emerald Coast OBGYN Clinical Research | Panama City | Florida | 32405 | — |
| Ideal Clinical Research, Inc. - ClinEdge - PPDS | Pembroke Pines | Florida | 33026-5207 | — |
| Precision Clinical Research - Plantation | Plantation | Florida | 33317 | — |
| GCP Global Clinical Professionals | St. Petersburg | Florida | 33705 | — |
| Tampa Bay Health Care | Tampa | Florida | 33615-4564 | — |
| CVS HealthHub - Atlanta S | Atlanta | Georgia | 30311 | — |
| CVS HealthHub - Atlanta | Atlanta | Georgia | 30329 | — |
| Tekton Research - Georgia - Platinum | Chamblee | Georgia | 30341 | — |
| Centricity Research - Roswel | Columbus | Georgia | 31904 | — |
| CVS HealthHub - Dacula | Dacula | Georgia | 30019 | — |
| IResearch Atlanta LLC | Decatur | Georgia | 30030 | — |
| CVS HealthHub - Kennesaw | Kennesaw | Georgia | 30152 | — |
| Drug Studies America - ClinEdge - PPDS | Marietta | Georgia | 30060 | — |
| CVS HealthHub - Mcdonough | McDonough | Georgia | 30253 | — |
| CVS HealthHub - Newman | Newnan | Georgia | 30265 | — |
| One Health Research Clinic, Inc. | Norcross | Georgia | 30093 | — |
| Mount Vernon Clinical Research, LLC - M3 WR - ERN - PPDS | Sandy Springs | Georgia | 30328 | — |
| CVS HealthHub - Savannah | Savannah | Georgia | 31405 | — |
| Clinical Research Prime - Clinedge | Idaho Falls | Idaho | 83404 | — |
| Velocity Clinical Research | Meridian | Idaho | 83642 | — |
| Affinity Health | Oak Brook | Illinois | 60523 | — |
| Optimal Research | Peoria | Illinois | 61614 | — |
| ASHA Clinical Research - ClinEdge | Hammond | Indiana | 46324 | — |
| Del Pilar Medical and Urgent Care | Mishawaka | Indiana | 46545-3452 | — |
| Iowa Clinic | Des Moines | Iowa | 50266 | — |
| Johnson Country Clin-Trials | Lenexa | Kansas | 66219 | — |
| Alliance for Multispecialty Research, LLC | Newton | Kansas | 67114 | — |
| Alliance for Multispecialty Research, LLC | Lexington | Kentucky | 40509 | — |
| Velocity Clinical Research - Covington | Metairie | Louisiana | 70006-4151 | — |
| Centennial Medical Group - Elkridge - Rx Trials | Elkridge | Maryland | 21075-6434 | — |
| Meridian Clinical Research-(Rockville Maryland) | Rockville | Maryland | 20854-2957 | — |
| DM Clinical Research - The Brook House | Brookline | Massachusetts | 02445 | — |
| Skylight Health Research - Burlington | Burlington | Massachusetts | 01803 | — |
| ActivMed Practices & Research Inc | Methuen | Massachusetts | 01844 | — |
| Voyage Medical - Michigan | Canton | Michigan | 48188-2866 | — |
| Wayne State University | Detroit | Michigan | 48202-2608 | — |
| Great Lakes Research Institute | Southfield | Michigan | 48075 | — |
| DM Clinical Research - Southfield | Southfield | Michigan | 48076 | — |
| Clinical Research Institute, Inc - CRN - PPDS | Minneapolis | Minnesota | 55402-2750 | — |
| University of Minnesota Clinical Research Unit | Minneapolis | Minnesota | 55454 | — |
| MedPharmics, LLC | Gulfport | Mississippi | 39503 | — |
| MediSync Clinical Research Hattiesburg Clinic | Petal | Mississippi | 39465-2932 | — |
| Boeson Research GTF - Great Falls | Great Falls | Montana | 59405 | — |
| Boeson Research KAL - Kalispell - ERN - PPDS | Kalispell | Montana | 59901 | — |
| Boeson Research MSO - Missoula | Missoula | Montana | 59804 | — |
| Meridian Clinical Research (Grand Island, Nebraska) | Grand Island | Nebraska | 68803-4327 | — |
| Meridian Clinical Research (Hastings, Nebraska) | Hastings | Nebraska | 68901-2615 | — |
| Be Well Clinical Studies, LLC - Lincoln - ERN - PPDS | Lincoln | Nebraska | 68516 | — |
| Meridian Clinical Research (Norfolk-Nebraska) | Norfolk | Nebraska | 68701-2669 | — |
| Quality Clinical Research | Omaha | Nebraska | 68114-3755 | — |
| Meridian Clinical Research-(Omaha Nebraska) | Omaha | Nebraska | 68134 | — |
| Clinical Research Center Of Nevada | Las Vegas | Nevada | 89106 | — |
| Med Clinic Research Partners, LLC | Irvington | New Jersey | 07111 | — |
| Albuquerque Clinical Trials Inc. | Albuquerque | New Mexico | 87102-3644 | — |
| MedPharmics, LLC. - Albuquerque | Albuquerque | New Mexico | 87102 | — |
| Meridian Clinical Research (Endwell-New York) - Platinum - PPDS | Binghamton | New York | 13901-1046 | — |
| WellNow Urgent Care Clinical Research | East Amherst | New York | 14051-2368 | — |
| Rochester Clinical Research, Inc | Rochester | New York | 14609-3173 | — |
| SUNY Upstate Medical Center | Syracuse | New York | 13210 | — |
| OnSite Clinical Solutions, LLC | Charlotte | North Carolina | 28277 | — |
| Carolina Institute for Clinical Research - M3 WR - ERN - PPDS | Fayetteville | North Carolina | 28303 | — |
| Monroe Biomedical Research (Venus St) | Monroe | North Carolina | 28112 | — |
| Lucas Research | Morehead City | North Carolina | 28557 | — |
| M3 Wake Research, Inc - M3 WR - ERN - PPDS | Raleigh | North Carolina | 27612 | — |
| Lillestol Research | Fargo | North Dakota | 58104 | — |
| CTI Clinical Research Center - ClinEdge - PPDS | Cincinnati | Ohio | 45212 | — |
| Meridian Cincinnati | Cincinnati | Ohio | 45219-2975 | — |
| University of Cincinnati Medical Center-Goodman St | Cincinnati | Ohio | 45267-2827 | — |
| ClinOhio Research Services | Columbus | Ohio | 43213-4440 | — |
| Aventiv Research Inc. | Columbus | Ohio | 43213 | — |
| WellNow Urgent Care & Research - Huber Heights | Columbus | Ohio | 43214-2635 | — |
| PriMed Clinical Research - ClinEdge | Dayton | Ohio | 45429 | — |
| Senders Pediatrics | South Euclid | Ohio | 44121 | — |
| Epic Medical Research Oklahoma | Chickasha | Oklahoma | 73018-2738 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| Tekton Research - Oklahoma - Platinum | Yukon | Oklahoma | 73099 | — |
| Velocity Clinical Research - Medford | Medford | Oregon | 97504 | — |
| SPICA Clinical Research | Columbia | South Carolina | 29223-6301 | — |
| PMG Research of Charleston LLC | Mt. Pleasant | South Carolina | 29464-1811 | — |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | — |
| ARC Clinical Research at Wilson Parke | Austin | Texas | 78726-4061 | — |
| Premier Family Physicians - Austin - Hunt | Austin | Texas | 78735 | — |
| ARC Clinical Research at William Cannon | Austin | Texas | 78745 | — |
| Tekton Research, Inc. | Austin | Texas | 78745 | — |
| Gadolin Research LLC | Beaumont | Texas | 77701-4627 | — |
| REX Clinical Trials | Beaumont | Texas | 77701 | — |
| Tekton Research - Beaumont | Beaumont | Texas | 77706-3061 | — |
| Velocity Clinical Research - Austin | Cedar Park | Texas | 78613-3936 | — |
| Global Medical Research | Dallas | Texas | 75224 | — |
| Zenos Clinical Research | Dallas | Texas | 75230 | — |
| ANRC Research | El Paso | Texas | 79936 | — |
| Village Health Partners Frisco Medical Village | Frisco | Texas | 75033 | — |
| Trio Clinical Trials LLC | Houston | Texas | 77008 | — |
| Vilo Research Group, L.L.C. | Houston | Texas | 77017-2338 | — |
| New Horizon Medical Group, LLC | Houston | Texas | 77063-5150 | — |
| Cedar Health Research - Fort Worth - PPDS | Irving | Texas | 75062-3621 | — |
| Helios CCR, Inc.-keller-PPDS | Keller | Texas | 76248 | — |
| University of Texas Medical Branch - Bay Colony, SIVS Clinical Trials Program | League City | Texas | 77573-1427 | — |
| BRCR Medical Center Inc - McAllen | McAllen | Texas | 78503 | — |
| Synergy Group US, LLC | Missouri City | Texas | 77459-4756 | — |
| Austin Regional Clinic ARC Clinical Research at Kelly Lane | Pflugerville | Texas | 78660 | — |
| GLRI McAllen Research | Pharr | Texas | 78577 | — |
| ACRC Trials - Independence Parkway - Plano - Hunt - PPDS | Plano | Texas | 75025-4002 | — |
| Epic Medical Research LLC | Red Oak | Texas | 75154 | — |
| Clinical Trials of Texas, Inc. - HyperCor | San Antonio | Texas | 78229-3539 | — |
| Diagnostics Research Group | San Antonio | Texas | 78229 | — |
| DM Clinical Research | Tomball | Texas | 77375 | — |
| Crossroads Clinical Research (Victoria) | Victoria | Texas | 77901 | — |
| ClinPoint Trials LLC | Waxahachie | Texas | 75165-1430 | — |
| Tanner Clinic | Layton | Utah | 84041 | — |
| Granger Medical Clinic - Riverton | Riverton | Utah | 84096-7012 | — |
| Foothill Family Clinic | Salt Lake City | Utah | 84109 | — |
| Foothill Family Clinic - South Clinic | Salt Lake City | Utah | 84121 | — |
| Velocity Clinical Research | West Jordan | Utah | 84088 | — |
| Health Research of Hampton Roads Inc. - ClinEdge | Newport News | Virginia | 23606 | — |
| York Clinical Research | Norfolk | Virginia | 23510-2014 | — |
| David Ramstad Associates Research - IACT - HyperCore - PPDS | Suffolk | Virginia | 23435 | — |
| Rainier Clinical Research Center | Renton | Washington | 98057 | — |
| Seattle Clinical Research Center | Seattle | Washington | 98105 | — |
| Velocity Clinical Research - Spokane - PPDS | Spokane | Washington | 99223 | — |
| University Of Wisconsin - Madison | Madison | Wisconsin | 53792 | — |
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 115 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05085366, 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 Dec 15, 2025 · Synced Oct 26, 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 NCT05085366 live on ClinicalTrials.gov.