AzTrials
AzTrials

Cytomegalovirus InfectionPhase 3NCT05085366

A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age

A Phase 3 study testing mRNA-1647 in people with Cytomegalovirus Infection, run by ModernaTX, Inc. at 296 sites in 13 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Cytomegalovirus Infection
What is being tested?
mRNA-1647
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
7,454 participants
Where
296 sitesin 13 countries
Study dates
26 Oct 2021to 4 Nov 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Participants aged ≥20 years, has or anticipates having direct exposure within 7 months after the planned first dose (in the home, socially, or occupationally) to at least 1 child ≤5 years of age. Direct exposure is defined as either participant is the parent, or participant has close contact (feeding, diaper changes, childcare/supervision) for at least 8 hours per week.
  • CMV-seronegative Cohort is CMV-seronegative based on CMV testing at Screening.
  • CMV-seropositive Cohort is CMV-seropositive based on CMV testing at Screening.
  • Investigator assessment confirms that the participant (including in the case of an emancipated minor), or parent(s)/legally acceptable representative (LAR)(s), as applicable, understand and are willing and physically able to comply with protocol-mandated follow-up including all study visits and procedures anticipated during the 30 month study period.
  • Female participants of child-bearing potential: Urine pregnancy test is negative at Screening and negative on the day of the first injection (Day 1). If the participant is sexually active with men, has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (Day 1) and agrees to continue adequate contraception through 3 months following the third study injection (Month 9/Day 257).
  • Extension substudy:
  • All consenting participants who were CMV-seronegative at Baseline in the mRNA-1647-P301 main study (including those who did seroconvert and did not seroconvert during the main study), received at least one study injection in the main study but did not withdraw study consent, and completed the final study visit in mRNA-1647-P301 main study.
  • Consenting participants in mRNA-1647-P301 main study who were CMV-seropositive at Baseline, received all 3 study injections, did not withdraw study consent, and completed the final study visit in the main study.

Who cannot join

  • History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
  • Received or plans to receive any nonstudy vaccine <28 days prior to and after any study injection; in addition, the following criteria for COVID-19 and influenza vaccines apply:
  • Any COVID-19 primary vaccination series must have been completed a minimum 28 days prior to receiving any dose of the study injection.
  • COVID-19 vaccines (including any booster dose, regardless of manufacturer) must be administered at least 28 days prior to or after any study injection.
  • Influenza vaccines may be administered > 14 days prior to or after any study injection.
  • Received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to the day of first injection (Day 1) (for corticosteroids, ≥5 milligrams (mg)/day of prednisone equivalent) or plans to do so during the course of the study. Inhaled, nasal, and topical steroids are allowed. Stable immunomodulator regimens used for managing environmental allergies are allowed.
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  • Receipt of an antiviral with activity against CMV (ganciclovir, valganciclovir, foscarnet, cidofovir, letermovir, acyclovir, valacyclovir) <2 weeks prior to the day of first injection or plans to do so during the course of the study.
  • Previous receipt of an investigational CMV vaccine.
  • Receipt of systemic immunoglobulins or blood products <3 months prior to the day of first injection.
  • Participated in an interventional clinical study <28 days prior to the day of first injection (Day 1) or plans to do so while enrolled in this study.
  • Participant has donated ≥450 milliliters (mL) of blood products <28 days prior to Screening.
  • Participant is a member of study team or is an immediate family member or household member of study personnel.
  • Extension substudy:
  • Receipt of any CMV vaccine other than mRNA-1647.
  • Diagnosis or condition that, in the judgment of the Investigator, may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures, including any medical, psychiatric, or occupational condition that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.

Trial locations and contacts

296 sites in 13 countries.

296 sites in 13 countries

United States181 sites

  • Albuquerque Clinical Trials Inc.

    Albuquerque, New Mexico, 87102-3644

  • MedPharmics, LLC. - Albuquerque

    Albuquerque, New Mexico, 87102

  • CVS HealthHub - Atlanta S

    Atlanta, Georgia, 30311

  • CVS HealthHub - Atlanta

    Atlanta, Georgia, 30329

  • Care Access Research - Aurora

    Aurora, Colorado, 80012

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045-7144

  • 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

  • Velocity Clinical Research - Banning

    Banning, California, 92220

  • Gadolin Research LLC

    Beaumont, Texas, 77701-4627

  • REX Clinical Trials

    Beaumont, Texas, 77701

  • Tekton Research - Beaumont

    Beaumont, Texas, 77706-3061

  • Meridian Clinical Research (Endwell-New York) - Platinum - PPDS

    Binghamton, New York, 13901-1046

  • Central Research Associates Inc

    Birmingham, Alabama, 35205

  • Accel Research Site - Achieve - Birmingham - ERN - PPDS

    Birmingham, Alabama, 35216

  • New England Research Associates LLC - ERN - PPDS

    Bridgeport, Connecticut, 06606

  • DM Clinical Research - The Brook House

    Brookline, Massachusetts, 02445

  • Skylight Health Research - Burlington

    Burlington, Massachusetts, 01803

  • Voyage Medical - Michigan

    Canton, Michigan, 48188-2866

  • Velocity Clinical Research - Austin

    Cedar Park, Texas, 78613-3936

  • Tekton Research - Georgia - Platinum

    Chamblee, Georgia, 30341

  • Chandler Clinical Trials, LLC

    Chandler, Arizona, 85224

  • OnSite Clinical Solutions, LLC

    Charlotte, North Carolina, 28277

  • Epic Medical Research Oklahoma

    Chickasha, Oklahoma, 73018-2738

  • Velocity Clinical Research - Chula Vista

    Chula Vista, California, 91911-6617

  • 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

  • Invictus Clinical Research Group, LLC

    Coconut Creek, Florida, 33073

  • SPICA Clinical Research

    Columbia, South Carolina, 29223-6301

  • Centricity Research - Roswel

    Columbus, Georgia, 31904

  • ClinOhio Research Services

    Columbus, Ohio, 43213-4440

  • Aventiv Research Inc.

    Columbus, Ohio, 43213

  • WellNow Urgent Care & Research - Huber Heights

    Columbus, Ohio, 43214-2635

  • 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

  • CVS HealthHub - Dacula

    Dacula, Georgia, 30019

  • Global Medical Research

    Dallas, Texas, 75224

  • Zenos Clinical Research

    Dallas, Texas, 75230

  • PriMed Clinical Research - ClinEdge

    Dayton, Ohio, 45429

  • IResearch Atlanta LLC

    Decatur, Georgia, 30030

  • Iowa Clinic

    Des Moines, Iowa, 50266

  • Wayne State University

    Detroit, Michigan, 48202-2608

  • Universal Axon Clinical Research

    Doral, Florida, 33166

  • Unique Clinical Trials, LLC

    Doral, Florida, 33172-1507

  • SEC Clinical Research LLC - Dothan - ClinEdge - PPDS

    Dothan, Alabama, 36305

  • WellNow Urgent Care Clinical Research

    East Amherst, New York, 14051-2368

  • Velocity Clinical Research, New Smyrna Beach

    Edgewater, Florida, 32132-2720

  • ANRC Research

    El Paso, Texas, 79936

  • Centennial Medical Group - Elkridge - Rx Trials

    Elkridge, Maryland, 21075-6434

  • Apex Research Group

    Fair Oaks, California, 95628-2500

  • Lillestol Research

    Fargo, North Dakota, 58104

  • Carolina Institute for Clinical Research - M3 WR - ERN - PPDS

    Fayetteville, North Carolina, 28303

  • Village Health Partners Frisco Medical Village

    Frisco, Texas, 75033

  • Ascada Research LLC

    Fullerton, California, 92835

  • Meridian Clinical Research (Grand Island, Nebraska)

    Grand Island, Nebraska, 68803-4327

  • Boeson Research GTF - Great Falls

    Great Falls, Montana, 59405

  • MedPharmics, LLC

    Gulfport, Mississippi, 39503

  • Lakeview Clinical Research

    Guntersville, Alabama, 35976

  • ASHA Clinical Research - ClinEdge

    Hammond, Indiana, 46324

  • Meridian Clinical Research (Hastings, Nebraska)

    Hastings, Nebraska, 68901-2615

  • Indago Research and Health Center

    Hialeah, Florida, 33012-4174

  • Best Quality Research, Inc

    Hialeah, Florida, 33016

  • 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

  • Clinical Research Prime - Clinedge

    Idaho Falls, Idaho, 83404

  • Cedar Health Research - Fort Worth - PPDS

    Irving, Texas, 75062-3621

  • Med Clinic Research Partners, LLC

    Irvington, New Jersey, 07111

  • Boeson Research KAL - Kalispell - ERN - PPDS

    Kalispell, Montana, 59901

  • Helios CCR, Inc.-keller-PPDS

    Keller, Texas, 76248

  • CVS HealthHub - Kennesaw

    Kennesaw, Georgia, 30152

  • Paradigm Clinical Research Center

    La Mesa, California, 91942

  • Velocity Clinical Research - San Diego

    La Mesa, California, 91942

  • Clinical Research Center Of Nevada

    Las Vegas, Nevada, 89106

  • Tanner Clinic

    Layton, Utah, 84041

  • University of Texas Medical Branch - Bay Colony, SIVS Clinical Trials Program

    League City, Texas, 77573-1427

  • Johnson Country Clin-Trials

    Lenexa, Kansas, 66219

  • Alliance for Multispecialty Research, LLC

    Lexington, Kentucky, 40509

  • Be Well Clinical Studies, LLC - Lincoln - ERN - PPDS

    Lincoln, Nebraska, 68516

  • 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

  • Long Beach Research Institute, LLC

    Long Beach, California, 90805

  • Long Beach Clinical Trials Services Inc.

    Long Beach, California, 90806

  • University Of Wisconsin - Madison

    Madison, Wisconsin, 53792

  • Drug Studies America - ClinEdge - PPDS

    Marietta, Georgia, 30060

  • BRCR Medical Center Inc - McAllen

    McAllen, Texas, 78503

  • CVS HealthHub - Mcdonough

    McDonough, Georgia, 30253

  • Velocity Clinical Research - Medford

    Medford, Oregon, 97504

  • Velocity Clinical Research

    Meridian, Idaho, 83642

  • Arizona Clinical Trials

    Mesa, Arizona, 85210

  • Velocity Clinical Research - Covington

    Metairie, Louisiana, 70006-4151

  • ActivMed Practices & Research Inc

    Methuen, Massachusetts, 01844

  • 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

  • Clinical Research Consultants LLC

    Milford, Connecticut, 06460-4647

  • Clinical Research Institute, Inc - CRN - PPDS

    Minneapolis, Minnesota, 55402-2750

  • University of Minnesota Clinical Research Unit

    Minneapolis, Minnesota, 55454

  • Del Pilar Medical and Urgent Care

    Mishawaka, Indiana, 46545-3452

  • Boeson Research MSO - Missoula

    Missoula, Montana, 59804

  • Synergy Group US, LLC

    Missouri City, Texas, 77459-4756

  • Monroe Biomedical Research (Venus St)

    Monroe, North Carolina, 28112

  • Catalina Research Institute LLC

    Montclair, California, 91763

  • Lucas Research

    Morehead City, North Carolina, 28557

  • PMG Research of Charleston LLC

    Mt. Pleasant, South Carolina, 29464-1811

  • CVS HealthHub - Newman

    Newnan, Georgia, 30265

  • Health Research of Hampton Roads Inc. - ClinEdge

    Newport News, Virginia, 23606

  • Alliance for Multispecialty Research, LLC

    Newton, Kansas, 67114

  • One Health Research Clinic, Inc.

    Norcross, Georgia, 30093

  • Meridian Clinical Research (Norfolk-Nebraska)

    Norfolk, Nebraska, 68701-2669

  • York Clinical Research

    Norfolk, Virginia, 23510-2014

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

  • Carbon Health- NoHo West Urgent Care and Primary Care

    North Hollywood, California, 91606

  • Affinity Health

    Oak Brook, Illinois, 60523

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Quality Clinical Research

    Omaha, Nebraska, 68114-3755

  • Meridian Clinical Research-(Omaha Nebraska)

    Omaha, Nebraska, 68134

  • 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

  • Optimal Research

    Peoria, Illinois, 61614

  • MediSync Clinical Research Hattiesburg Clinic

    Petal, Mississippi, 39465-2932

  • Austin Regional Clinic ARC Clinical Research at Kelly Lane

    Pflugerville, Texas, 78660

  • GLRI McAllen Research

    Pharr, Texas, 78577

  • 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

  • ACRC Trials - Independence Parkway - Plano - Hunt - PPDS

    Plano, Texas, 75025-4002

  • Precision Clinical Research - Plantation

    Plantation, Florida, 33317

  • Empire Clinical Research

    Pomona, California, 91767

  • M3 Wake Research, Inc - M3 WR - ERN - PPDS

    Raleigh, North Carolina, 27612

  • Epic Medical Research LLC

    Red Oak, Texas, 75154

  • Paradigm Clinical Research Institute, Inc. - ClinEdge

    Redding, California, 96001-0172

  • Rainier Clinical Research Center

    Renton, Washington, 98057

  • Granger Medical Clinic - Riverton

    Riverton, Utah, 84096-7012

  • Rochester Clinical Research, Inc

    Rochester, New York, 14609-3173

  • Meridian Clinical Research-(Rockville Maryland)

    Rockville, Maryland, 20854-2957

  • Smart Cures Clinical Research

    Rolling Hills Estates, California, 90274-7604

  • Northern California Research Corp

    Sacramento, California, 95821

  • Foothill Family Clinic

    Salt Lake City, Utah, 84109

  • Foothill Family Clinic - South Clinic

    Salt Lake City, Utah, 84121

  • Clinical Trials of Texas, Inc. - HyperCor

    San Antonio, Texas, 78229-3539

  • Diagnostics Research Group

    San Antonio, Texas, 78229

  • Womens Healthcare Research Corporation ERN PPDS

    San Diego, California, 92111

  • Mount Vernon Clinical Research, LLC - M3 WR - ERN - PPDS

    Sandy Springs, Georgia, 30328

  • Care Access Research - Santa Clarita

    Santa Clarita, California, 91321

  • CVS HealthHub - Savannah

    Savannah, Georgia, 31405

  • Seattle Clinical Research Center

    Seattle, Washington, 98105

  • Senders Pediatrics

    South Euclid, Ohio, 44121

  • Great Lakes Research Institute

    Southfield, Michigan, 48075

  • DM Clinical Research - Southfield

    Southfield, Michigan, 48076

  • Velocity Clinical Research - Spokane - PPDS

    Spokane, Washington, 99223

  • GCP Global Clinical Professionals

    St. Petersburg, Florida, 33705

  • Stanford University School of Medicine

    Stanford, California, 94305

  • David Ramstad Associates Research - IACT - HyperCore - PPDS

    Suffolk, Virginia, 23435

  • Epic Medical Research Arizona

    Surprise, Arizona, 85378-9021

  • SUNY Upstate Medical Center

    Syracuse, New York, 13210

  • Tampa Bay Health Care

    Tampa, Florida, 33615-4564

  • Voyage Medical

    Tempe, Arizona, 85282

  • Hope Research Institute LLC

    Tempe, Arizona, 85284

  • Clinical Trials Management Services, LLC

    Thousand Oaks, California, 91360

  • DM Clinical Research

    Tomball, Texas, 77375

  • 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

  • Bayview Research Group

    Valley Village, California, 91607

  • Crossroads Clinical Research (Victoria)

    Victoria, Texas, 77901

  • Emerson Clinical Research Institute LLC - Kennedy St

    Washington D.C., District of Columbia, 20011

  • ClinPoint Trials LLC

    Waxahachie, Texas, 75165-1430

  • Next Level Clinical Trials

    West Covina, California, 91730

  • Velocity Clinical Research

    West Jordan, Utah, 84088

  • Paradigm Clinical Research Institute Inc - ClinEdge

    Wheat Ridge, Colorado, 80033

  • Tekton Research - Oklahoma - Platinum

    Yukon, Oklahoma, 73099

Other trials in United States

Canada16 sites

  • LMC Manna Research - Burlington - HyperCore - PPDS

    Burlington, Ontario, L7M 4Y1

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 1Z1

  • Canadian Center for Vaccinology

    Halifax, Nova Scotia, B3K 6R8

  • Centricity Research - Quebec - HyperCore - PPDS

    Lévis, Quebec, G6W OM5

  • Centricity Research - Mirabel - HyperCore - PPDS

    Mirabel, Quebec, J7J 2K8

  • McGill University Health Center

    Montreal, Quebec, H4A 3J1

  • Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • McGill University Health Centre-Vaccine Study Centre

    Pierrefonds, Quebec, H9H 4Y6

  • Centricity Research - Montreal - HyperCore - PPDS

    Pointe-Claire, Quebec, H9R 4S3

  • Diex Recherche - Québec - HyperCore

    Québec, Quebec, G1N 4V3

  • Diex Recherche - Joilette - HyperCore - PPDS

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • Bluewater Clinical Research Group

    Sarnia, Ontario, N7T 4X3

  • Diex Recherche - Sherbrooke - HyperCore

    Sherbrooke, Quebec, J1L 0H8

  • Dr. Anil K. Gupta Medicine Professional Corporation

    Toronto, Ontario, M9V 4B4

  • Centricity Research - Toronto

    Toronto, Ontario, M9W 4L6

  • Diex Recherche - Victoriaville - HyperCore

    Victoriaville, Quebec, G6P 6P6

Other trials in Canada

Australia15 sites

  • Paratus Clinical Research - Western Sydney

    Blacktown, New South Wales, 2148

  • Emeritus Research

    Botany, North South Wales, 02019

  • Northern Beaches Clinical Research

    Brookvale, New South Wales, 2100

  • Paratus Clinical Research

    Bruce, Australian Capital Territory, 2617

  • Emeritus Research

    Camberwell, Victoria, 03124

  • Northside Health

    Coffs Harbour, New South Wales, 2450

  • Barwon Health

    Geelong, Victoria, 3220

  • Kanwal Medical Complex

    Kanwal, New South Wales, 2259

  • The University of Melbourne

    Melbourne, Victoria, 3000

  • Hunter Diabetes Centre

    Merewether, New South Wales, 2291

  • University of the Sunshine Coast, Health Hub Morayfield

    Morayfield, Queensland, 4506

  • Telethon Kids Institute

    Nedlands, Western Australia, 6009

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • University of the Sunshine Coast

    Sippy Downs, Queensland, 4556

  • USC Southbank

    Southbank, Queensland, 4101

Other trials in Australia

Germany15 sites

  • Berliner Centrum für Reise- und Tropenmedizin BCRT GmbH

    Berlin, 10117

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia, 53127

  • Klifeck GmbH

    Delitzsch, Saxony, 04509

  • Frauenarztpraxis Erwin Göckeler-Leopold

    Geseke, North Rhine-Westphalia, 59590

  • Bernhard Nocht Centre for Clinical Trials (BNCCT)am Bernhard-Nocht-Institut für Tropenmedizin

    Hamburg, 20359

  • Velocity Clinical Research - Hamburg - PPDS

    Hamburg, 22143

  • Office of Klaus H. Peters, Dr.med

    Hamburg, 22159

  • Velocity Clniical Research Leipzip Gmbh

    Leipzig, 04103

  • AmBeNet GmbH

    Leipzig, 04107

  • Dermatologie Quist

    Mainz, Rhineland-Palatinate, 55128

  • Centrum Für Diagnostik und Gesundheit

    München, 80809

  • RED-Institut GmbH

    Oldenburg in Holstein, Schleswig-Holstein, 23758

  • Praxis Reinfeld-Mitte

    Reinfeld, Schleswig-Holstein, 23858

  • TriDerm

    Stuttgart, Baden-Wurttemberg, 70178

  • Medislim GmbH - Zentrum fuer Ambulante Klinische Forschung

    Weinheim, 69469

Other trials in Germany

Japan15 sites

  • Clinical Trial Site

    Chuo-ku, Tokyo, 103-0027

  • Clinical Trial Site

    Chuo-ku, Tokyo, 104-0031

  • Clinical trial site

    Fukuoka, Fukuoka, 812-0053

  • Clinical Trial Site

    Funabashi-shi, Chiba, 274-0071

  • Clinical Trial Site

    Habikino-shi, Osaka, 583-8588

  • Clinical Trial Site

    Kawagoe-shi, Saitama, 350-1122

  • Kobe University Hospital

    Kobe, Hyôgo, 650-0017

  • Clinical Trial Site

    Osaka, Osaka, 556-0005

  • Clinical trial site

    Osaka-shi Osaka, Kansai, 530-0002

  • Clinical Trial Site

    Sakai-shi, Osaka, 593-8322

  • Clinical Trial Site

    Sapporo, Hokkaido, 004-0052

  • Clinical Trial Site

    Sapporo, Hokkaido, 063-0841

  • Clinical Trial Site

    Shibuya-ku, Tokyo, 151-0051

  • Clinical Trial Site

    Shinjuku, Tokyo, 162-0052

  • Clinical Trial Site

    Taito-ku, Tokyo, 111-0036

Other trials in Japan

Finland10 sites

  • Espoon rokotetutkimusklinikka

    Espoo, Uusimaa, 02230

  • Etelä Helsingin Rokotetutkimusklinikka

    Helsinki, Etelä-Suomen Lään, 00100

  • Itä Helsingin Rokotetutkimusklinikka

    Helsinki, Uusimaa, 00930

  • Järvenpään Rokotetutkimusklinikka

    Jarvenpaa, Uusimaa, 04400

  • Kokkolan Rokotetutkimusklinikka

    Kokkola, Keski-Pohjanmaa, 67100

  • Oulun Rokotetutkimusklinikka

    Oulu, Oulun Lääni, 90220

  • Porin Rokotetutkimusklinikka

    Pori, Satakunta, 28100

  • Tampereen Yliopisto Seinajoen Rokotusklinikka

    Seinäjoki, South Ostrobothnia, 60100

  • Tampereen Rokotetutkimusklinikka

    Tampere, Pirkanmaa, 33100

  • Turun Rokotetutkimusklinikka

    Turku, Västra Finlands Län, 20520

Other trials in Finland

Israel10 sites

  • Soroka University Medical Centre

    Beer Sheva, Tel Aviv, 8457108

  • Shamir Medical Center Assaf Harofeh

    Beer Yaakov, Rishon Lezion, 70300

  • Rambam Medical Center - PPDS

    Haifa, Haifa Hefa, 3109601

  • Hadassah Medical Center - PPDS

    Jerusalem, Yerushalayim Al Quds, 91120

  • Shaare Zedek Medical Center

    Jerusalem, Yerushalayim Al Quds, 9372212

  • Meir Medical Center

    Kfar Saba, 4428164

  • Sheba Medical Center - PPDS

    Petah Tikva, Central District of Israel, 49100

  • Rabin Medical Center

    Petah Tikva, 49100

  • Maccabi Hashalom

    Tel Aviv, Tel Aviv, 6789140

  • Tel Aviv Sourasky Medical Center PPDS

    Tel Aviv, 6423906

Other trials in Israel

France9 sites

  • Centre Hospitalier Departemental de Vendee

    La Roche-sur-Yon, 85925

  • Centre Hospitalier et Universitaire de Limoges

    Limoges, 87042

  • CHU Montpellier - Hôpital St Eloi

    Montpellier, 34295

  • CHRU Nantes

    Nantes, Pays de la Loire Region, 44093

  • Hopital Necker

    Paris, 75015

  • Groupe Hospitalier Cochin Saint Vincent de Paul

    Paris, 75679

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre Hospitalier Universitaire de Saint Etienne

    Saint-Priest-en-Jarez, 42270

  • CHRU de Tours

    Tours, 37044

Other trials in France

Spain8 sites

  • Hospital Clinic de Barcelona

    Barcelona, Catalonia, 08036

  • ABS Centelles

    Centelles, Catalonia, 08540

  • C.H. Regional Reina Sofia

    Córdoba, Andalusia, 14004

  • Hospital Universitario La Paz.

    Madrid, 28046

  • Hospital Quironsalud Malaga

    Málaga, Andalusia, 29004

  • Hospital HM Puerta del Sur

    Móstoles, Madrird, 28938

  • CHUS - H. Clinico U. de Santiago

    Santiago de Compostela, Galicia, 15706

  • Instituto Hispalense de Pediatria

    Seville, Andalusia, 41014

Other trials in Spain

United Kingdom7 sites

  • St Michaels Hospital

    Bristol, South West England, BS2 8DX

  • Lakeside Surgery

    Corby, Northamptonshire, NN17 2UR

  • William Harvey Clinical Research Centre

    London, England, EC1M 6BQ

  • St George s Vaccine Institute

    London, England, SW17 0QT

  • The James Cook University Hospital

    Middlesbrough, Cleveland, TS4 3BW

  • NIHR Patient Recruitment Centre: Newcastle

    Newcastle upon Tyne, Northumberland, NE1 4LP

  • NIHR Clinical Research Facility, University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD

Other trials in United Kingdom

Estonia5 sites

  • Vee Family Doctors Center Ltd

    Paide, Järvamaa, 72713

  • CCBR Clinical Research

    Tallinn, Harju, 10128

  • Al Mare Family Doctors Centre

    Tallinn, Harju, 10617

  • Merelahe Family Doctors Centre

    Tallinn, Harju, 10617

  • Clinical Research Centre Ltd.

    Tartu, Tartu, 50106

Other trials in Estonia

Belgium3 sites

  • AZ Sint-Lucas Brugge

    Bruges, West-Vlaanderen, 08310

  • Center for Vaccinology (CEVAC)

    Ghent, Oost-Vlaanderen, 9000

  • CHU de Liège

    Liège, B-4000

Other trials in Belgium

Italy2 sites

  • Ospedale Policlinico San Martino

    Genova, 16132

  • Fondazione IRCCS San Gerardo dei Tintori - MBBM - c/o Centro Maria Letizia Verga

    Monza, 20900

Other trials in Italy

About this study

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

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.

Being tested
mRNA-1647, Placebo
Keywords
mRNA-1647, Moderna, Cytomegalovirus, CMV, Cytomegalovirus Vaccine, Cytomegalovirus Infections, Cytomegalovirus Congenital, Virus Diseases, Infection Viral, DNA Virus Infections, Messenger RNA
Medical subject headings
Cytomegalovirus Infections, Virus Diseases, DNA Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mRNA-1647Biological

    Lyophilized product that is reconstituted with 0.9% sodium chloride (normal saline)

  • PlaceboBiological

    0.9% sodium chloride (normal saline) injection

Study groups in NCT05085366
Study groupRoleWhat they receive
mRNA-1647ExperimentalParticipants will receive mRNA-1647 vaccine by intramuscular (IM) injection on Day 1, Day 57, and Day 169.
Receives: Biological: mRNA-1647
PlaceboPlacebo comparatorParticipants will receive mRNA-1647 vaccine matching placebo by IM injection on Day 1, Day 57, and Day 169.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Seroconversion From a Negative to a Positive Result for Serum Immunoglobulin G (IgG) Against Antigens not Encoded by mRNA-1647

    Measured: Day 197 (28 days after the third injection) up to Day 887 (24 months after the third injection)

  2. Number of Participants With Solicited Adverse Reactions (ARs)

    Measured: Up to 176 days (7 days after each injection)

  3. Number of Participants With Unsolicited Adverse Events (AEs)

    Measured: Up to 197 days (28 days after each injection)

  4. Number of Participants With Medically-Attended Adverse Events (MAAEs)

    Measured: Day 1 through 6 months after the last injection (up to 347 days)

  5. Number of Participants With Adverse Event of Special Interests (AESIs) and Serious Adverse Events (SAEs)

    Measured: Day 1 through Month 30

  6. Geometric Mean Titers (GMTs) of Antigen-Specific Neutralizing Antibody (nAb)

    Measured: Month 30 up to Month 54

  7. Geometric Mean Concentration (GMC) of Binding Antibody

    Measured: Month 30 up to Month 54

  8. Seroconversion From a Negative to a Positive Result for Serum IgG Against Antigens not Encoded by mRNA-1647

    Measured: Month 30 up to Month 54

  9. Number of Participants With Systemic Viral Dissemination

    Measured: Month 30 up to Month 54

Secondary outcomes (6)

  1. GMTs of Antigen-Specific nAb

    Measured: Day 1, Months 3, 7, 12, 18, 24, and 30

  2. GMC of Antigen-Specific Binding Antibody

    Measured: Day 1, Months 3, 7, 12, 18, 24, and 30

  3. Number of Participants with AEs leading to Study Discontinuation, SAEs and Deaths

    Measured: Month 30 up to Month 54

  4. Number of Participants With Systemic Viral Dissemination

    Measured: Day 1 through Month 30

  5. Number of Participants With Positive Urine CMV Polymerase Chain Reaction (PCR) Results Post Seroconversion

    Measured: Day 1 through Month 30

  6. Number of Participants With Positive Urine CMV PCR Results Post Seroconversion

    Measured: Month 30 up to Month 54

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2021
  2. Study start26 Oct 2021
  3. Primary completion4 Nov 2025
  4. Study completion4 Nov 2025

Why it stopped: The Sponsor decided to terminate the study after it did not meet the primary efficacy endpoint at final analysis. The safety profile was consistent with prior studies, and no safety concerns were raised by the Data and Safety Monitoring Board.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
7,454 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05085366
Sponsor's protocol ID
mRNA-1647-P301
Other IDs
2020-006051-17, 2023-508820-37-00, 2023
Status last verified
Dec 2025
First submitted
7 Oct 2021
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Galiza EP, Khalil A, Heath PT. Update on Vaccines in Antenatal Care. Pediatr Infect Dis J. 2024 Feb 1;43(2):e60-e62. doi: 10.1097/INF.0000000000004183. Epub 2023 Dec 27. No abstract available.

    PubMed 38190492

  • Stewart AG, Kotton CN. What's New: Updates on Cytomegalovirus in Solid Organ Transplantation. Transplantation. 2024 Apr 1;108(4):884-897. doi: 10.1097/TP.0000000000004855. Epub 2023 Oct 30.

    PubMed 37899366

  • Kadambari S, Evans C, Lyall H. Congenital Infections: Priorities and Possibilities for Resource-limited Settings. Pediatr Infect Dis J. 2023 Feb 1;42(2):e45-e47. doi: 10.1097/INF.0000000000003710. Epub 2022 Sep 12. No abstract available.

    PubMed 36102707

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing mRNA-1647 in people with Cytomegalovirus Infection, run by ModernaTX, Inc. at 296 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 296 sites in United States, Canada, Australia, Germany, Japan and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The Sponsor decided to terminate the study after it did not meet the primary efficacy endpoint at final analysis. The safety profile was consistent with prior studies, and no safety concerns were raised by the Data and Safety Monitoring Board.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroconversion From a Negative to a Positive Result for Serum Immunoglobulin G (IgG) Against Antigens not Encoded by mRNA-1647 (time frame: Day 197 (28 days after the third injection) up to Day 887 (24 months after the third injection)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05085366, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.

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