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

NCT05085366 | Terminated Phase 3 DMC FDA Drug

• 3 other identifiers: mRNA-1647-P3012020-006051-172023-508820-37-00
• Study Type: interventional
• Target: 7,454
• Locations: 12 countries
• Sites: 291

Brief 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. 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.

Conditions

Cytomegalovirus Infection

Keywords

mRNA-1647; Moderna; Cytomegalovirus; CMV; Cytomegalovirus Vaccine; Cytomegalovirus Infections; Cytomegalovirus Congenital; Virus Diseases; Infection Viral; DNA Virus Infections; Messenger RNA

Outcome Measures

Primary Outcomes (9)

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

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

• Number of Participants With Solicited Adverse Reactions (ARs)

  Up to 176 days (7 days after each injection)

• Number of Participants With Unsolicited Adverse Events (AEs)

  Up to 197 days (28 days after each injection)

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

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

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

  Day 1 through Month 30

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

  Month 30 up to Month 54

• Geometric Mean Concentration (GMC) of Binding Antibody

  Month 30 up to Month 54

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

  Month 30 up to Month 54

• Number of Participants With Systemic Viral Dissemination

  Month 30 up to Month 54

Secondary Outcomes (6)

• GMTs of Antigen-Specific nAb

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

• GMC of Antigen-Specific Binding Antibody

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

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

  Month 30 up to Month 54

• Number of Participants With Systemic Viral Dissemination

  Day 1 through Month 30

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

  Day 1 through Month 30

Study Arms (2)

mRNA-1647

EXPERIMENTAL

Participants will receive mRNA-1647 vaccine by intramuscular (IM) injection on Day 1, Day 57, and Day 169.

Biological: mRNA-1647

Placebo

PLACEBO COMPARATOR

Participants will receive mRNA-1647 vaccine matching placebo by IM injection on Day 1, Day 57, and Day 169.

Biological: Placebo

Interventions

mRNA-1647 BIOLOGICAL

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

mRNA-1647

Placebo BIOLOGICAL

0.9% sodium chloride (normal saline) injection

Placebo

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (296)

Central Research Associates Inc

Birmingham, Alabama, 35205, United States

Location

Accel Research Site - Achieve - Birmingham - ERN - PPDS

Birmingham, Alabama, 35216, United States

Location

SEC Clinical Research LLC - Dothan - ClinEdge - PPDS

Dothan, Alabama, 36305, United States

Location

Lakeview Clinical Research

Guntersville, Alabama, 35976, United States

Location

Chandler Clinical Trials, LLC

Chandler, Arizona, 85224, United States

Location

Arizona Clinical Trials

Mesa, Arizona, 85210, United States

Location

Phoenix Clinical LLC

Phoenix, Arizona, 85014, United States

Location

MedPharmics, LLC

Phoenix, Arizona, 85015-1105, United States

Location

Hope Research Institute LLC

Phoenix, Arizona, 85018, United States

Location

Hope Research Institute LLC

Phoenix, Arizona, 85023, United States

Location

Epic Medical Research Arizona

Surprise, Arizona, 85378-9021, United States

Location

Voyage Medical

Tempe, Arizona, 85282, United States

Location

Hope Research Institute LLC

Tempe, Arizona, 85284, United States

Location

Tucson Neuroscience Research - M3 WR - ERN - PPDS

Tucson, Arizona, 85710-6155, United States

Location

The Institute for Liver Health-Tucson

Tucson, Arizona, 85712-4046, United States

Location

Del Sol Research Management - ClinEdge - PPDS

Tucson, Arizona, 85715, United States

Location

Noble Clinical Research

Tucson, Arizona, 86704, United States

Location

Baptist Health Center for Clinical Research

Little Rock, Arkansas, 72205-6355, United States

Location

Preferred Research Partners

Little Rock, Arkansas, 72211, United States

Location

Applied Research Center of Arkansas - Clinedge - PPDS

Little Rock, Arkansas, 72212, United States

Location

Velocity Clinical Research - Banning

Banning, California, 92220, United States

Location

Velocity Clinical Research - Chula Vista

Chula Vista, California, 91911-6617, United States

Location

Apex Research Group

Fair Oaks, California, 95628-2500, United States

Location

Ascada Research LLC

Fullerton, California, 92835, United States

Location

Paradigm Clinical Research Center

La Mesa, California, 91942, United States

Location

Velocity Clinical Research - San Diego

La Mesa, California, 91942, United States

Location

Long Beach Research Institute, LLC

Long Beach, California, 90805, United States

Location

Long Beach Clinical Trials Services Inc.

Long Beach, California, 90806, United States

Location

Catalina Research Institute LLC

Montclair, California, 91763, United States

Location

Carbon Health- NoHo West Urgent Care and Primary Care

North Hollywood, California, 91606, United States

Location

Empire Clinical Research

Pomona, California, 91767, United States

Location

Paradigm Clinical Research Institute, Inc. - ClinEdge

Redding, California, 96001-0172, United States

Location

Smart Cures Clinical Research

Rolling Hills Estates, California, 90274-7604, United States

Location

Northern California Research Corp

Sacramento, California, 95821, United States

Location

Womens Healthcare Research Corporation ERN PPDS

San Diego, California, 92111, United States

Location

Care Access Research - Santa Clarita

Santa Clarita, California, 91321, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Clinical Trials Management Services, LLC

Thousand Oaks, California, 91360, United States

Location

Bayview Research Group

Valley Village, California, 91607, United States

Location

Next Level Clinical Trials

West Covina, California, 91730, United States

Location

Care Access Research - Aurora

Aurora, Colorado, 80012, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045-7144, United States

Location

Paradigm Clinical Research Institute Inc - ClinEdge

Wheat Ridge, Colorado, 80033, United States

Location

New England Research Associates LLC - ERN - PPDS

Bridgeport, Connecticut, 06606, United States

Location

Clinical Research Consultants LLC

Milford, Connecticut, 06460-4647, United States

Location

Emerson Clinical Research Institute LLC - Kennedy St

Washington D.C., District of Columbia, 20011, United States

Location

Invictus Clinical Research Group, LLC

Coconut Creek, Florida, 33073, United States

Location

Luna Research LLC

Coral Gables, Florida, 33134-2220, United States

Location

Herco Medical and Research Center, Inc.

Coral Gables, Florida, 33134-2537, United States

Location

Precision Clinical Research, LLC

Coral Springs, Florida, 33065, United States

Location

Universal Axon Clinical Research

Doral, Florida, 33166, United States

Location

Unique Clinical Trials, LLC

Doral, Florida, 33172-1507, United States

Location

Velocity Clinical Research, New Smyrna Beach

Edgewater, Florida, 32132-2720, United States

Location

Indago Research and Health Center

Hialeah, Florida, 33012-4174, United States

Location

Best Quality Research, Inc

Hialeah, Florida, 33016, United States

Location

Florida International Medical Research

Miami, Florida, 33155-2164, United States

Location

Miami Clinical Research

Miami, Florida, 33155, United States

Location

Spotlight Research Center, LLC

Miami, Florida, 33176, United States

Location

Floridian Clinical Research - ClinEdge - PPDS

Miami Lakes, Florida, 33016, United States

Location

Ormond Beach Clinical Research

Ormond Beach, Florida, 32174-8196, United States

Location

Emerald Coast OBGYN Clinical Research

Panama City, Florida, 32405, United States

Location

Ideal Clinical Research, Inc. - ClinEdge - PPDS

Pembroke Pines, Florida, 33026-5207, United States

Location

Precision Clinical Research - Plantation

Plantation, Florida, 33317, United States

Location

GCP Global Clinical Professionals

St. Petersburg, Florida, 33705, United States

Location

Tampa Bay Health Care

Tampa, Florida, 33615-4564, United States

Location

CVS HealthHub - Atlanta S

Atlanta, Georgia, 30311, United States

Location

CVS HealthHub - Atlanta

Atlanta, Georgia, 30329, United States

Location

Tekton Research - Georgia - Platinum

Chamblee, Georgia, 30341, United States

Location

Centricity Research - Roswel

Columbus, Georgia, 31904, United States

Location

CVS HealthHub - Dacula

Dacula, Georgia, 30019, United States

Location

IResearch Atlanta LLC

Decatur, Georgia, 30030, United States

Location

CVS HealthHub - Kennesaw

Kennesaw, Georgia, 30152, United States

Location

Drug Studies America - ClinEdge - PPDS

Marietta, Georgia, 30060, United States

Location

CVS HealthHub - Mcdonough

McDonough, Georgia, 30253, United States

Location

CVS HealthHub - Newman

Newnan, Georgia, 30265, United States

Location

One Health Research Clinic, Inc.

Norcross, Georgia, 30093, United States

Location

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

Sandy Springs, Georgia, 30328, United States

Location

CVS HealthHub - Savannah

Savannah, Georgia, 31405, United States

Location

Clinical Research Prime - Clinedge

Idaho Falls, Idaho, 83404, United States

Location

Velocity Clinical Research

Meridian, Idaho, 83642, United States

Location

Affinity Health

Oak Brook, Illinois, 60523, United States

Location

Optimal Research

Peoria, Illinois, 61614, United States

Location

ASHA Clinical Research - ClinEdge

Hammond, Indiana, 46324, United States

Location

Del Pilar Medical and Urgent Care

Mishawaka, Indiana, 46545-3452, United States

Location

Iowa Clinic

Des Moines, Iowa, 50266, United States

Location

Johnson Country Clin-Trials

Lenexa, Kansas, 66219, United States

Location

Alliance for Multispecialty Research, LLC

Newton, Kansas, 67114, United States

Location

Alliance for Multispecialty Research, LLC

Lexington, Kentucky, 40509, United States

Location

Velocity Clinical Research - Covington

Metairie, Louisiana, 70006-4151, United States

Location

Centennial Medical Group - Elkridge - Rx Trials

Elkridge, Maryland, 21075-6434, United States

Location

Meridian Clinical Research-(Rockville Maryland)

Rockville, Maryland, 20854-2957, United States

Location

DM Clinical Research - The Brook House

Brookline, Massachusetts, 02445, United States

Location

Skylight Health Research - Burlington

Burlington, Massachusetts, 01803, United States

Location

ActivMed Practices & Research Inc

Methuen, Massachusetts, 01844, United States

Location

Voyage Medical - Michigan

Canton, Michigan, 48188-2866, United States

Location

Wayne State University

Detroit, Michigan, 48202-2608, United States

Location

Great Lakes Research Institute

Southfield, Michigan, 48075, United States

Location

DM Clinical Research - Southfield

Southfield, Michigan, 48076, United States

Location

Clinical Research Institute, Inc - CRN - PPDS

Minneapolis, Minnesota, 55402-2750, United States

Location

University of Minnesota Clinical Research Unit

Minneapolis, Minnesota, 55454, United States

Location

MedPharmics, LLC

Gulfport, Mississippi, 39503, United States

Location

MediSync Clinical Research Hattiesburg Clinic

Petal, Mississippi, 39465-2932, United States

Location

Boeson Research GTF - Great Falls

Great Falls, Montana, 59405, United States

Location

Boeson Research KAL - Kalispell - ERN - PPDS

Kalispell, Montana, 59901, United States

Location

Boeson Research MSO - Missoula

Missoula, Montana, 59804, United States

Location

Meridian Clinical Research (Grand Island, Nebraska)

Grand Island, Nebraska, 68803-4327, United States

Location

Meridian Clinical Research (Hastings, Nebraska)

Hastings, Nebraska, 68901-2615, United States

Location

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

Lincoln, Nebraska, 68516, United States

Location

Meridian Clinical Research (Norfolk-Nebraska)

Norfolk, Nebraska, 68701-2669, United States

Location

Quality Clinical Research

Omaha, Nebraska, 68114-3755, United States

Location

Meridian Clinical Research-(Omaha Nebraska)

Omaha, Nebraska, 68134, United States

Location

Clinical Research Center Of Nevada

Las Vegas, Nevada, 89106, United States

Location

Med Clinic Research Partners, LLC

Irvington, New Jersey, 07111, United States

Location

Albuquerque Clinical Trials Inc.

Albuquerque, New Mexico, 87102-3644, United States

Location

MedPharmics, LLC. - Albuquerque

Albuquerque, New Mexico, 87102, United States

Location

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

Binghamton, New York, 13901-1046, United States

Location

WellNow Urgent Care Clinical Research

East Amherst, New York, 14051-2368, United States

Location

Rochester Clinical Research, Inc

Rochester, New York, 14609-3173, United States

Location

SUNY Upstate Medical Center

Syracuse, New York, 13210, United States

Location

OnSite Clinical Solutions, LLC

Charlotte, North Carolina, 28277, United States

Location

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

Fayetteville, North Carolina, 28303, United States

Location

Monroe Biomedical Research (Venus St)

Monroe, North Carolina, 28112, United States

Location

Lucas Research

Morehead City, North Carolina, 28557, United States

Location

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

Raleigh, North Carolina, 27612, United States

Location

Lillestol Research

Fargo, North Dakota, 58104, United States

Location

CTI Clinical Research Center - ClinEdge - PPDS

Cincinnati, Ohio, 45212, United States

Location

Meridian Cincinnati

Cincinnati, Ohio, 45219-2975, United States

Location

University of Cincinnati Medical Center-Goodman St

Cincinnati, Ohio, 45267-2827, United States

Location

ClinOhio Research Services

Columbus, Ohio, 43213-4440, United States

Location

Aventiv Research Inc.

Columbus, Ohio, 43213, United States

Location

WellNow Urgent Care & Research - Huber Heights

Columbus, Ohio, 43214-2635, United States

Location

PriMed Clinical Research - ClinEdge

Dayton, Ohio, 45429, United States

Location

Senders Pediatrics

South Euclid, Ohio, 44121, United States

Location

Epic Medical Research Oklahoma

Chickasha, Oklahoma, 73018-2738, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Tekton Research - Oklahoma - Platinum

Yukon, Oklahoma, 73099, United States

Location

Velocity Clinical Research - Medford

Medford, Oregon, 97504, United States

Location

SPICA Clinical Research

Columbia, South Carolina, 29223-6301, United States

Location

PMG Research of Charleston LLC

Mt. Pleasant, South Carolina, 29464-1811, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

ARC Clinical Research at Wilson Parke

Austin, Texas, 78726-4061, United States

Location

Premier Family Physicians - Austin - Hunt

Austin, Texas, 78735, United States

Location

ARC Clinical Research at William Cannon

Austin, Texas, 78745, United States

Location

Tekton Research, Inc.

Austin, Texas, 78745, United States

Location

Gadolin Research LLC

Beaumont, Texas, 77701-4627, United States

Location

REX Clinical Trials

Beaumont, Texas, 77701, United States

Location

Tekton Research - Beaumont

Beaumont, Texas, 77706-3061, United States

Location

Velocity Clinical Research - Austin

Cedar Park, Texas, 78613-3936, United States

Location

Global Medical Research

Dallas, Texas, 75224, United States

Location

Zenos Clinical Research

Dallas, Texas, 75230, United States

Location

ANRC Research

El Paso, Texas, 79936, United States

Location

Village Health Partners Frisco Medical Village

Frisco, Texas, 75033, United States

Location

Trio Clinical Trials LLC

Houston, Texas, 77008, United States

Location

Vilo Research Group, L.L.C.

Houston, Texas, 77017-2338, United States

Location

New Horizon Medical Group, LLC

Houston, Texas, 77063-5150, United States

Location

Cedar Health Research - Fort Worth - PPDS

Irving, Texas, 75062-3621, United States

Location

Helios CCR, Inc.-keller-PPDS

Keller, Texas, 76248, United States

Location

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

League City, Texas, 77573-1427, United States

Location

BRCR Medical Center Inc - McAllen

McAllen, Texas, 78503, United States

Location

Synergy Group US, LLC

Missouri City, Texas, 77459-4756, United States

Location

Austin Regional Clinic ARC Clinical Research at Kelly Lane

Pflugerville, Texas, 78660, United States

Location

GLRI McAllen Research

Pharr, Texas, 78577, United States

Location

ACRC Trials - Independence Parkway - Plano - Hunt - PPDS

Plano, Texas, 75025-4002, United States

Location

Epic Medical Research LLC

Red Oak, Texas, 75154, United States

Location

Clinical Trials of Texas, Inc. - HyperCor

San Antonio, Texas, 78229-3539, United States

Location

Diagnostics Research Group

San Antonio, Texas, 78229, United States

Location

DM Clinical Research

Tomball, Texas, 77375, United States

Location

Crossroads Clinical Research (Victoria)

Victoria, Texas, 77901, United States

Location

ClinPoint Trials LLC

Waxahachie, Texas, 75165-1430, United States

Location

Tanner Clinic

Layton, Utah, 84041, United States

Location

Granger Medical Clinic - Riverton

Riverton, Utah, 84096-7012, United States

Location

Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

Foothill Family Clinic - South Clinic

Salt Lake City, Utah, 84121, United States

Location

Velocity Clinical Research

West Jordan, Utah, 84088, United States

Location

Health Research of Hampton Roads Inc. - ClinEdge

Newport News, Virginia, 23606, United States

Location

York Clinical Research

Norfolk, Virginia, 23510-2014, United States

Location

David Ramstad Associates Research - IACT - HyperCore - PPDS

Suffolk, Virginia, 23435, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

Seattle Clinical Research Center

Seattle, Washington, 98105, United States

Location

Velocity Clinical Research - Spokane - PPDS

Spokane, Washington, 99223, United States

Location

University Of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

Location

Paratus Clinical Research

Bruce, Australian Capital Territory, 2617, Australia

Location

Paratus Clinical Research - Western Sydney

Blacktown, New South Wales, 2148, Australia

Location

Northern Beaches Clinical Research

Brookvale, New South Wales, 2100, Australia

Location

Northside Health

Coffs Harbour, New South Wales, 2450, Australia

Location

Kanwal Medical Complex

Kanwal, New South Wales, 2259, Australia

Location

Hunter Diabetes Centre

Merewether, New South Wales, 2291, Australia

Location

Emeritus Research

Botany, North South Wales, 02019, Australia

Location

University of the Sunshine Coast, Health Hub Morayfield

Morayfield, Queensland, 4506, Australia

Location

University of the Sunshine Coast

Sippy Downs, Queensland, 4556, Australia

Location

USC Southbank

Southbank, Queensland, 4101, Australia

Location

Emeritus Research

Camberwell, Victoria, 03124, Australia

Location

Barwon Health

Geelong, Victoria, 3220, Australia

Location

The University of Melbourne

Melbourne, Victoria, 3000, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Telethon Kids Institute

Nedlands, Western Australia, 6009, Australia

Location

Center for Vaccinology (CEVAC)

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

AZ Sint-Lucas Brugge

Bruges, West-Vlaanderen, 08310, Belgium

Location

CHU de Liège

Liège, B-4000, Belgium

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 1Z1, Canada

Location

Canadian Center for Vaccinology

Halifax, Nova Scotia, B3K 6R8, Canada

Location

LMC Manna Research - Burlington - HyperCore - PPDS

Burlington, Ontario, L7M 4Y1, Canada

Location

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Bluewater Clinical Research Group

Sarnia, Ontario, N7T 4X3, Canada

Location

Dr. Anil K. Gupta Medicine Professional Corporation

Toronto, Ontario, M9V 4B4, Canada

Location

Centricity Research - Toronto

Toronto, Ontario, M9W 4L6, Canada

Location

Centricity Research - Quebec - HyperCore - PPDS

Lévis, Quebec, G6W OM5, Canada

Location

Centricity Research - Mirabel - HyperCore - PPDS

Mirabel, Quebec, J7J 2K8, Canada

Location

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

Location

McGill University Health Centre-Vaccine Study Centre

Pierrefonds, Quebec, H9H 4Y6, Canada

Location

Centricity Research - Montreal - HyperCore - PPDS

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

Diex Recherche - Québec - HyperCore

Québec, Quebec, G1N 4V3, Canada

Location

Diex Recherche - Joilette - HyperCore - PPDS

Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

Location

Diex Recherche - Sherbrooke - HyperCore

Sherbrooke, Quebec, J1L 0H8, Canada

Location

Diex Recherche - Victoriaville - HyperCore

Victoriaville, Quebec, G6P 6P6, Canada

Location

CCBR Clinical Research

Tallinn, Harju, 10128, Estonia

Location

Al Mare Family Doctors Centre

Tallinn, Harju, 10617, Estonia

Location

Merelahe Family Doctors Centre

Tallinn, Harju, 10617, Estonia

Location

Vee Family Doctors Center Ltd

Paide, Järvamaa, 72713, Estonia

Location

Clinical Research Centre Ltd.

Tartu, Tartu, 50106, Estonia

Location

Etelä Helsingin Rokotetutkimusklinikka

Helsinki, Etelä-Suomen Lään, 00100, Finland

Location

Kokkolan Rokotetutkimusklinikka

Kokkola, Keski-Pohjanmaa, 67100, Finland

Location

Oulun Rokotetutkimusklinikka

Oulu, Oulun Lääni, 90220, Finland

Location

Tampereen Rokotetutkimusklinikka

Tampere, Pirkanmaa, 33100, Finland

Location

Porin Rokotetutkimusklinikka

Pori, Satakunta, 28100, Finland

Location

Tampereen Yliopisto Seinajoen Rokotusklinikka

Seinäjoki, South Ostrobothnia, 60100, Finland

Location

Espoon rokotetutkimusklinikka

Espoo, Uusimaa, 02230, Finland

Location

Itä Helsingin Rokotetutkimusklinikka

Helsinki, Uusimaa, 00930, Finland

Location

Järvenpään Rokotetutkimusklinikka

Jarvenpaa, Uusimaa, 04400, Finland

Location

Turun Rokotetutkimusklinikka

Turku, Västra Finlands Län, 20520, Finland

Location

CHRU Nantes

Nantes, Pays de la Loire Region, 44093, France

Location

Centre Hospitalier Departemental de Vendee

La Roche-sur-Yon, 85925, France

Location

Centre Hospitalier et Universitaire de Limoges

Limoges, 87042, France

Location

CHU Montpellier - Hôpital St Eloi

Montpellier, 34295, France

Location

Hopital Necker

Paris, 75015, France

Location

Groupe Hospitalier Cochin Saint Vincent de Paul

Paris, 75679, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Centre Hospitalier Universitaire de Saint Etienne

Saint-Priest-en-Jarez, 42270, France

Location

CHRU de Tours

Tours, 37044, France

Location

TriDerm

Stuttgart, Baden-Wurttemberg, 70178, Germany

Location

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Frauenarztpraxis Erwin Göckeler-Leopold

Geseke, North Rhine-Westphalia, 59590, Germany

Location

Dermatologie Quist

Mainz, Rhineland-Palatinate, 55128, Germany

Location

Klifeck GmbH

Delitzsch, Saxony, 04509, Germany

Location

RED-Institut GmbH

Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany

Location

Praxis Reinfeld-Mitte

Reinfeld, Schleswig-Holstein, 23858, Germany

Location

Berliner Centrum für Reise- und Tropenmedizin BCRT GmbH

Berlin, 10117, Germany

Location

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

Hamburg, 20359, Germany

Location

Velocity Clinical Research - Hamburg - PPDS

Hamburg, 22143, Germany

Location

Office of Klaus H. Peters, Dr.med

Hamburg, 22159, Germany

Location

Velocity Clniical Research Leipzip Gmbh

Leipzig, 04103, Germany

Location

AmBeNet GmbH

Leipzig, 04107, Germany

Location

Centrum Für Diagnostik und Gesundheit

München, 80809, Germany

Location

Medislim GmbH - Zentrum fuer Ambulante Klinische Forschung

Weinheim, 69469, Germany

Location

Sheba Medical Center - PPDS

Petah Tikva, Central District of Israel, 49100, Israel

Location

Rambam Medical Center - PPDS

Haifa, Haifa Hefa, 3109601, Israel

Location

Shamir Medical Center Assaf Harofeh

Beer Yaakov, Rishon Lezion, 70300, Israel

Location

Soroka University Medical Centre

Beer Sheva, Tel Aviv, 8457108, Israel

Location

Maccabi Hashalom

Tel Aviv, Tel Aviv, 6789140, Israel

Location

Hadassah Medical Center - PPDS

Jerusalem, Yerushalayim Al Quds, 91120, Israel

Location

Shaare Zedek Medical Center

Jerusalem, Yerushalayim Al Quds, 9372212, Israel

Location

Meir Medical Center

Kfar Saba, 4428164, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Tel Aviv Sourasky Medical Center PPDS

Tel Aviv, 6423906, Israel

Location

Ospedale Policlinico San Martino

Genova, 16132, Italy

Location

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

Monza, 20900, Italy

Location

Clinical Trial Site

Funabashi-shi, Chiba, 274-0071, Japan

Location

Clinical trial site

Fukuoka, Fukuoka, 812-0053, Japan

Location

Clinical Trial Site

Sapporo, Hokkaido, 004-0052, Japan

Location

Clinical Trial Site

Sapporo, Hokkaido, 063-0841, Japan

Location

Kobe University Hospital

Kobe, Hyôgo, 650-0017, Japan

Location

Clinical trial site

Osaka-shi Osaka, Kansai, 530-0002, Japan

Location

Clinical Trial Site

Habikino-shi, Osaka, 583-8588, Japan

Location

Clinical Trial Site

Osaka, Osaka, 556-0005, Japan

Location

Clinical Trial Site

Sakai-shi, Osaka, 593-8322, Japan

Location

Clinical Trial Site

Kawagoe-shi, Saitama, 350-1122, Japan

Location

Clinical Trial Site

Chuo-ku, Tokyo, 103-0027, Japan

Location

Clinical Trial Site

Chuo-ku, Tokyo, 104-0031, Japan

Location

Clinical Trial Site

Shibuya-ku, Tokyo, 151-0051, Japan

Location

Clinical Trial Site

Shinjuku, Tokyo, 162-0052, Japan

Location

Clinical Trial Site

Taito-ku, Tokyo, 111-0036, Japan

Location

C.H. Regional Reina Sofia

Córdoba, Andalusia, 14004, Spain

Location

Hospital Quironsalud Malaga

Málaga, Andalusia, 29004, Spain

Location

Instituto Hispalense de Pediatria

Seville, Andalusia, 41014, Spain

Location

Hospital Clinic de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

ABS Centelles

Centelles, Catalonia, 08540, Spain

Location

CHUS - H. Clinico U. de Santiago

Santiago de Compostela, Galicia, 15706, Spain

Location

Hospital HM Puerta del Sur

Móstoles, Madrird, 28938, Spain

Location

Hospital Universitario La Paz.

Madrid, 28046, Spain

Location

The James Cook University Hospital

Middlesbrough, Cleveland, TS4 3BW, United Kingdom

Location

William Harvey Clinical Research Centre

London, England, EC1M 6BQ, United Kingdom

Location

St George s Vaccine Institute

London, England, SW17 0QT, United Kingdom

Location

Lakeside Surgery

Corby, Northamptonshire, NN17 2UR, United Kingdom

Location

NIHR Patient Recruitment Centre: Newcastle

Newcastle upon Tyne, Northumberland, NE1 4LP, United Kingdom

Location

St Michaels Hospital

Bristol, South West England, BS2 8DX, United Kingdom

Location

NIHR Clinical Research Facility, University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 38190492 DERIVED

• 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.

  PMID: 37899366 DERIVED

• 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.

  PMID: 36102707 DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections; Virus Diseases; DNA Virus Infections

Interventions

mRNA-1647 cytomegalovirus vaccine

Condition Hierarchy (Ancestors)

Herpesviridae Infections; Infections

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Observer-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 20, 2021
• Study Start: October 26, 2021
• Primary Completion: November 4, 2025
• Study Completion: November 4, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

JP (15); FI (10); CA (16); IT (2); US (181); ES (8); IL (10); FR (9); AU (15); DE (15); BE (3); GB (7)