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

Cytomegalovirus Infection Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05085366
• Other study ID #: mRNA-1647-P301
• Secondary ID: 2020-006051-1720
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 26, 2021
• Est. completion date: April 6, 2026

Study information

• Verified date: April 2024
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The purpose of the Phase 3 extension sub study is to extend the observation period of the main study and to evaluate the longer-term immune persistence of mRNA-1647 vaccine administered to CMV-seronegative females who complete mRNA-1647-P301 main study and to assess for CMV seroconversion in CMV-seronegative participants who did not seroconvert during mRNA-1647-P301 main study. No interventional vaccine will be administered in the extension study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7454
• Est. completion date: April 6, 2026
• Est. primary completion date: April 6, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 40 Years

Eligibility

Key Inclusion Criteria:

• 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 in mRNA-1647-P301 main study who were CMV-seronegative at baseline and did not seroconvert during the main study, received at least one study injection, and completed the final study visit in the main study.
• Consenting participants in mRNA-1647-P301 main study who were CMV-seronegative at baseline, received all 3 study injections, and completed the final study visit in the main study.

Key Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cytomegalovirus Infection
• Cytomegalovirus Infections
• Infections

Intervention

Biological:
• mRNA-1647
Lyophilized product that is reconstituted with 0.9% sodium chloride (normal saline)
• Placebo
0.9% sodium chloride (normal saline) injection

Locations

Country	Name	City	State
Australia	Paratus Clinical Research - Western Sydney	Blacktown	New South Wales
Australia	Emeritus Research	Botany	North South Wales
Australia	Northern Beaches Clinical Research	Brookvale	New South Wales
Australia	Paratus Clinical Research	Bruce	Australian Capital Territory
Australia	Emeritus Research	Camberwell	Victoria
Australia	Northside Health	Coffs Harbour	New South Wales
Australia	Barwon Health	Geelong	Victoria
Australia	Kanwal Medical Complex	Kanwal	New South Wales
Australia	The University of Melbourne	Melbourne	Victoria
Australia	Hunter Diabetes Centre	Merewether	New South Wales
Australia	University of the Sunshine Coast, Health Hub Morayfield	Morayfield	Queensland
Australia	Telethon Kids Institute	Nedlands	Western Australia
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	University of the Sunshine Coast	Sippy Downs	Queensland
Australia	USC Southbank	Southbank	Queensland
Belgium	AZ Sint-Lucas Brugge	Brugge	West-Vlaanderen
Belgium	Center for Vaccinology (CEVAC)	Gent	Oost-Vlaanderen
Belgium	CHU de Liège	Liège
Canada	LMC Manna Research - Burlington - HyperCore - PPDS	Burlington	Ontario
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Canadian Center for Vaccinology	Halifax	Nova Scotia
Canada	Centricity Research - Quebec - HyperCore - PPDS	Levis	Quebec
Canada	Centricity Research - Mirabel - HyperCore - PPDS	Mirabel	Quebec
Canada	McGill University Health Center	Montreal	Quebec
Canada	Ottawa Hospital	Ottawa	Ontario
Canada	McGill University Health Centre-Vaccine Study Centre	Pierrefonds	Quebec
Canada	Centricity Research - Montreal - HyperCore - PPDS	Pointe-Claire	Quebec
Canada	Diex Recherche - Québec - HyperCore	Québec City	Quebec
Canada	Diex Recherche - Joilette - HyperCore - PPDS	Saint-Charles-Borromée	Quebec
Canada	Bluewater Clinical Research Group	Sarnia	Ontario
Canada	Diex Recherche - Sherbrooke - HyperCore	Sherbrooke	Quebec
Canada	Centricity Research - Toronto	Toronto	Ontario
Canada	Dr. Anil K. Gupta Medicine Professional Corporation	Toronto	Ontario
Canada	Diex Recherche - Victoriaville - HyperCore	Victoriaville	Quebec
Estonia	Vee Family Doctors Center Ltd	Paide	Järvamaa
Estonia	Al Mare Family Doctors Centre	Tallinn	Harjumaa
Estonia	CCBR Clinical Research	Tallinn	Harjumaa
Estonia	Merelahe Family Doctors Centre	Tallinn	Harjumaa
Estonia	Clinical Research Centre Ltd.	Tartu	Tartumaa
Finland	Espoon rokotetutkimusklinikka	Espoo	Uusimaa
Finland	Etelä Helsingin Rokotetutkimusklinikka	Helsinki	Etelä-Suomen Lään
Finland	Itä Helsingin Rokotetutkimusklinikka	Helsinki	Uusimaa
Finland	Järvenpään Rokotetutkimusklinikka	Järvenpää	Uusimaa
Finland	Kokkolan Rokotetutkimusklinikka	Kokkola	Keski-Pohjanmaa
Finland	Oulun Rokotetutkimusklinikka	Oulu	Oulun Lääni
Finland	Porin Rokotetutkimusklinikka	Pori	Satakunta
Finland	Tampereen Yliopisto Seinajoen Rokotusklinikka	Seinäjoki	Etelä-Pohjanmaa
Finland	Tampereen Rokotetutkimusklinikka	Tampere	Pirkanmaa
Finland	Turun Rokotetutkimusklinikka	Turku	Västra Finlands Län
France	Centre Hospitalier Departemental de Vendee	La Roche-sur-Yon
France	Centre Hospitalier et Universitaire de Limoges	Limoges
France	CHU Montpellier - Hôpital St Eloi	Montpellier
France	CHRU Nantes	Nantes	Pays De La Loire
France	Groupe Hospitalier Cochin Saint Vincent de Paul	Paris
France	Hopital Necker	Paris
France	Centre Hospitalier Lyon Sud	Pierre Bénite
France	Centre Hospitalier Universitaire de Saint Etienne	Saint-Priest-en-Jarez
France	CHRU de Tours	Tours
Germany	Berliner Centrum für Reise- und Tropenmedizin BCRT GmbH	Berlin
Germany	Universitätsklinikum Bonn	Bonn	Nordrhein-Westfalen
Germany	Klifeck GmbH	Delitzsch	Sachsen
Germany	Frauenarztpraxis Erwin Göckeler-Leopold	Geseke	North Rhine-Westphalia
Germany	Bernhard Nocht Centre for Clinical Trials (BNCCT)am Bernhard-Nocht-Institut für Tropenmedizin	Hamburg
Germany	Office of Klaus H. Peters, Dr.med	Hamburg
Germany	Velocity Clinical Research - Hamburg - PPDS	Hamburg
Germany	AmBeNet GmbH	Leipzig
Germany	Velocity Clniical Research Leipzip Gmbh	Leipzig
Germany	Dermatologie Quist	Mainz	Rhineland-Palatinate
Germany	Centrum Für Diagnostik und Gesundheit	München
Germany	RED-Institut GmbH	Oldenburg in Holstein	Schleswig-Holstein
Germany	Praxis Reinfeld-Mitte	Reinfeld	Schleswig-Holstein
Germany	TriDerm	Stuttgart	Baden-Württemberg
Germany	Medislim GmbH - Zentrum fuer Ambulante Klinische Forschung	Weinheim
Israel	Soroka University Medical Centre	Beer Sheva	Tel Aviv District
Israel	Shamir Medical Center Assaf Harofeh	Beer Yaakov	Rishon Lezion
Israel	Rambam Medical Center - PPDS	Haifa	Haifa Hefa
Israel	Hadassah Medical Center - PPDS	Jerusalem	Yerushalayim Al Quds
Israel	Shaare Zedek Medical Center	Jerusalem	Yerushalayim Al Quds
Israel	Meir Medical Center	Kfar Saba
Israel	Sheba Medical Center - PPDS	Petah Tiqva	Central District Of Israel
Israel	Rabin Medical Center	Petah-Tikva
Israel	Maccabi Hashalom	Tel Aviv	Tel Aviv District
Israel	Tel Aviv Sourasky Medical Center PPDS	Tel-Aviv
Italy	Ospedale Policlinico San Martino	Genova
Italy	Fondazione IRCCS San Gerardo dei Tintori - MBBM - c/o Centro Maria Letizia Verga	Monza
Japan	Clinical Trial Site	Chuo-ku	Tokyo
Japan	Clinical Trial Site	Chuo-ku	Tokyo
Japan	Clinical trial site	Fukuoka-shi	Fukuoka
Japan	Clinical Trial Site	Funabashi-shi	Chiba
Japan	Clinical Trial Site	Habikino-shi	Osaka
Japan	Clinical Trial Site	Kawagoe-shi	Saitama
Japan	Kobe University Hospital	Kobe-Shi	Hyôgo
Japan	Clinical Trial Site	Osaka-shi	Osaka
Japan	Clinical trial site	Osaka-shi Osaka	Kansai
Japan	Clinical Trial Site	Sakai-shi	Osaka
Japan	Clinical Trial Site	Sapporo-shi	Hokkaido
Japan	Clinical Trial Site	Sapporo-shi	Hokkaido
Japan	Clinical Trial Site	Shibuya-ku	Tokyo
Japan	Clinical Trial Site	Shinjuku	Tokyo
Japan	Clinical Trial Site	Taito-ku	Tokyo
Spain	Hospital Clinic de Barcelona	Barcelona	Catalonia
Spain	ABS Centelles	Centelles	Catalonia
Spain	C.H. Regional Reina Sofia	Cordoba	Andalusia
Spain	Hospital Universitario La Paz.	Madrid
Spain	Hospital Quironsalud Malaga	Malaga	Andalusia
Spain	Hospital HM Puerta del Sur	Mostoles	Madrird
Spain	CHUS - H. Clinico U. de Santiago	Santiago de Compostela	Galicia
Spain	Instituto Hispalense de Pediatria	Sevilla	Andalusia
United Kingdom	St Michaels Hospital	Bristol	South West England
United Kingdom	Lakeside Surgery	Corby	Northamptonshire
United Kingdom	St George s Vaccine Institute	London	England
United Kingdom	William Harvey Clinical Research Centre	London	England
United Kingdom	The James Cook University Hospital	Middlesbrough	Cleveland
United Kingdom	NIHR Patient Recruitment Centre: Newcastle	Newcastle upon Tyne	Northumberland
United Kingdom	NIHR Clinical Research Facility, University Hospital Southampton NHS Foundation Trust	Southampton
United States	Albuquerque Clinical Trials Inc.	Albuquerque	New Mexico
United States	MedPharmics, LLC. - Albuquerque	Albuquerque	New Mexico
United States	CVS HealthHub - Atlanta	Atlanta	Georgia
United States	CVS HealthHub - Atlanta S	Atlanta	Georgia
United States	Care Access Research - Aurora	Aurora	Colorado
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	ARC Clinical Research at William Cannon	Austin	Texas
United States	ARC Clinical Research at Wilson Parke	Austin	Texas
United States	Premier Family Physicians - Austin - Hunt	Austin	Texas
United States	Tekton Research, Inc.	Austin	Texas
United States	Velocity Clinical Research - Banning	Banning	California
United States	Gadolin Research LLC	Beaumont	Texas
United States	REX Clinical Trials	Beaumont	Texas
United States	Tekton Research - Beaumont	Beaumont	Texas
United States	Meridian Clinical Research (Endwell-New York) - Platinum - PPDS	Binghamton	New York
United States	Accel Research Site - Achieve - Birmingham - ERN - PPDS	Birmingham	Alabama
United States	Central Research Associates Inc	Birmingham	Alabama
United States	New England Research Associates LLC - ERN - PPDS	Bridgeport	Connecticut
United States	DM Clinical Research - The Brook House	Brookline	Massachusetts
United States	Skylight Health Research - Burlington	Burlington	Massachusetts
United States	Voyage Medical - Michigan	Canton	Michigan
United States	Velocity Clinical Research - Austin	Cedar Park	Texas
United States	Tekton Research - Georgia - Platinum	Chamblee	Georgia
United States	Chandler Clinical Trials, LLC	Chandler	Arizona
United States	OnSite Clinical Solutions, LLC	Charlotte	North Carolina
United States	Epic Medical Research Oklahoma	Chickasha	Oklahoma
United States	Velocity Clinical Research - Chula Vista	Chula Vista	California
United States	CTI Clinical Research Center - ClinEdge - PPDS	Cincinnati	Ohio
United States	Meridian Cincinnati	Cincinnati	Ohio
United States	University of Cincinnati Medical Center-Goodman St	Cincinnati	Ohio
United States	Invictus Clinical Research Group, LLC	Coconut Creek	Florida
United States	SPICA Clinical Research	Columbia	South Carolina
United States	Aventiv Research Inc.	Columbus	Ohio
United States	Centricity Research - Roswel	Columbus	Georgia
United States	ClinOhio Research Services	Columbus	Ohio
United States	WellNow Urgent Care & Research - Huber Heights	Columbus	Ohio
United States	Herco Medical and Research Center, Inc.	Coral Gables	Florida
United States	Luna Research LLC	Coral Gables	Florida
United States	Precision Clinical Research, LLC	Coral Springs	Florida
United States	CVS HealthHub - Dacula	Dacula	Georgia
United States	Global Medical Research	Dallas	Texas
United States	Zenos Clinical Research	Dallas	Texas
United States	PriMed Clinical Research - ClinEdge	Dayton	Ohio
United States	IResearch Atlanta LLC	Decatur	Georgia
United States	Iowa Clinic	Des Moines	Iowa
United States	Wayne State University	Detroit	Michigan
United States	Unique Clinical Trials, LLC	Doral	Florida
United States	Universal Axon Clinical Research	Doral	Florida
United States	SEC Clinical Research LLC - Dothan - ClinEdge - PPDS	Dothan	Alabama
United States	WellNow Urgent Care Clinical Research	E. Amherst	New York
United States	Velocity Clinical Research, New Smyrna Beach	Edgewater	Florida
United States	ANRC Research	El Paso	Texas
United States	Centennial Medical Group - Elkridge - Rx Trials	Elkridge	Maryland
United States	Apex Research Group	Fair Oaks	California
United States	Lillestol Research	Fargo	North Dakota
United States	Carolina Institute for Clinical Research - M3 WR - ERN - PPDS	Fayetteville	North Carolina
United States	Village Health Partners Frisco Medical Village	Frisco	Texas
United States	Ascada Research LLC	Fullerton	California
United States	Meridian Clinical Research (Grand Island, Nebraska)	Grand Island	Nebraska
United States	Boeson Research GTF - Great Falls	Great Falls	Montana
United States	MedPharmics, LLC	Gulfport	Mississippi
United States	Lakeview Clinical Research	Guntersville	Alabama
United States	ASHA Clinical Research - ClinEdge	Hammond	Indiana
United States	Meridian Clinical Research (Hastings, Nebraska)	Hastings	Nebraska
United States	Best Quality Research, Inc	Hialeah	Florida
United States	Indago Research and Health Center	Hialeah	Florida
United States	New Horizon Medical Group, LLC	Houston	Texas
United States	Trio Clinical Trials LLC	Houston	Texas
United States	Vilo Research Group, L.L.C.	Houston	Texas
United States	Clinical Research Prime - Clinedge	Idaho Falls	Idaho
United States	Cedar Health Research - Fort Worth - PPDS	Irving	Texas
United States	Med Clinic Research Partners, LLC	Irvington	New Jersey
United States	Boeson Research KAL - Kalispell - ERN - PPDS	Kalispell	Montana
United States	Helios CCR, Inc.-keller-PPDS	Keller	Texas
United States	CVS HealthHub - Kennesaw	Kennesaw	Georgia
United States	Paradigm Clinical Research Center	La Mesa	California
United States	Velocity Clinical Research - San Diego	La Mesa	California
United States	Clinical Research Center Of Nevada	Las Vegas	Nevada
United States	Tanner Clinic	Layton	Utah
United States	University of Texas Medical Branch - Bay Colony, SIVS Clinical Trials Program	League City	Texas
United States	Johnson Country Clin-Trials	Lenexa	Kansas
United States	Alliance for Multispecialty Research, LLC	Lexington	Kentucky
United States	Be Well Clinical Studies, LLC - Lincoln - ERN - PPDS	Lincoln	Nebraska
United States	Applied Research Center of Arkansas - Clinedge - PPDS	Little Rock	Arkansas
United States	Baptist Health Center for Clinical Research	Little Rock	Arkansas
United States	Preferred Research Partners	Little Rock	Arkansas
United States	Long Beach Clinical Trials Services Inc.	Long Beach	California
United States	Long Beach Research Institute, LLC	Long Beach	California
United States	University Of Wisconsin - Madison	Madison	Wisconsin
United States	Drug Studies America - ClinEdge - PPDS	Marietta	Georgia
United States	BRCR Medical Center Inc - McAllen	McAllen	Texas
United States	CVS HealthHub - Mcdonough	McDonough	Georgia
United States	Velocity Clinical Research - Medford	Medford	Oregon
United States	Velocity Clinical Research	Meridian	Idaho
United States	Arizona Clinical Trials	Mesa	Arizona
United States	Velocity Clinical Research - Covington	Metairie	Louisiana
United States	ActivMed Practices & Research Inc	Methuen	Massachusetts
United States	Florida International Medical Research	Miami	Florida
United States	Miami Clinical Research	Miami	Florida
United States	Spotlight Research Center, LLC	Miami	Florida
United States	Floridian Clinical Research - ClinEdge - PPDS	Miami Lakes	Florida
United States	Clinical Research Consultants LLC	Milford	Connecticut
United States	Clinical Research Institute, Inc - CRN - PPDS	Minneapolis	Minnesota
United States	University of Minnesota Clinical Research Unit	Minneapolis	Minnesota
United States	Del Pilar Medical and Urgent Care	Mishawaka	Indiana
United States	Boeson Research MSO - Missoula	Missoula	Montana
United States	Synergy Group US, LLC	Missouri City	Texas
United States	Monroe Biomedical Research (Venus St)	Monroe	North Carolina
United States	Catalina Research Institute LLC	Montclair	California
United States	Lucas Research	Morehead City	North Carolina
United States	PMG Research of Charleston LLC	Mount Pleasant	South Carolina
United States	CVS HealthHub - Newman	Newnan	Georgia
United States	Health Research of Hampton Roads Inc. - ClinEdge	Newport News	Virginia
United States	Alliance for Multispecialty Research, LLC	Newton	Kansas
United States	One Health Research Clinic, Inc.	Norcross	Georgia
United States	Meridian Clinical Research (Norfolk-Nebraska)	Norfolk	Nebraska
United States	York Clinical Research	Norfolk	Virginia
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	Carbon Health- NoHo West Urgent Care and Primary Care	North Hollywood	California
United States	Affinity Health	Oak Brook	Illinois
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Meridian Clinical Research-(Omaha Nebraska)	Omaha	Nebraska
United States	Quality Clinical Research	Omaha	Nebraska
United States	Ormond Beach Clinical Research	Ormond Beach	Florida
United States	Emerald Coast OBGYN Clinical Research	Panama City	Florida
United States	Ideal Clinical Research, Inc. - ClinEdge - PPDS	Pembroke Pines	Florida
United States	Optimal Research	Peoria	Illinois
United States	MediSync Clinical Research Hattiesburg Clinic	Petal	Mississippi
United States	Austin Regional Clinic ARC Clinical Research at Kelly Lane	Pflugerville	Texas
United States	GLRI McAllen Research	Pharr	Texas
United States	Hope Research Institute LLC	Phoenix	Arizona
United States	Hope Research Institute LLC	Phoenix	Arizona
United States	MedPharmics, LLC	Phoenix	Arizona
United States	Phoenix Clinical LLC	Phoenix	Arizona
United States	ACRC Trials - Independence Parkway - Plano - Hunt - PPDS	Plano	Texas
United States	Precision Clinical Research - Plantation	Plantation	Florida
United States	Empire Clinical Research	Pomona	California
United States	M3 Wake Research, Inc - M3 WR - ERN - PPDS	Raleigh	North Carolina
United States	Epic Medical Research LLC	Red Oak	Texas
United States	Paradigm Clinical Research Institute, Inc. - ClinEdge	Redding	California
United States	Rainier Clinical Research Center	Renton	Washington
United States	Granger Medical Clinic - Riverton	Riverton	Utah
United States	Rochester Clinical Research, Inc	Rochester	New York
United States	Meridian Clinical Research-(Rockville Maryland)	Rockville	Maryland
United States	Smart Cures Clinical Research	Rolling Hills Estates	California
United States	Northern California Research Corp	Sacramento	California
United States	GCP Global Clinical Professionals	Saint Petersburg	Florida
United States	Foothill Family Clinic	Salt Lake City	Utah
United States	Foothill Family Clinic - South Clinic	Salt Lake City	Utah
United States	Clinical Trials of Texas, Inc. - HyperCor	San Antonio	Texas
United States	Diagnostics Research Group	San Antonio	Texas
United States	Womens Healthcare Research Corporation ERN PPDS	San Diego	California
United States	Mount Vernon Clinical Research, LLC - M3 WR - ERN - PPDS	Sandy Springs	Georgia
United States	Care Access Research - Santa Clarita	Santa Clarita	California
United States	CVS HealthHub - Savannah	Savannah	Georgia
United States	Seattle Clinical Research Center	Seattle	Washington
United States	Senders Pediatrics	South Euclid	Ohio
United States	DM Clinical Research - Southfield	Southfield	Michigan
United States	Great Lakes Research Institute	Southfield	Michigan
United States	Velocity Clinical Research - Spokane - PPDS	Spokane	Washington
United States	Stanford University School of Medicine	Stanford	California
United States	David Ramstad Associates Research - IACT - HyperCore - PPDS	Suffolk	Virginia
United States	Epic Medical Research Arizona	Surprise	Arizona
United States	SUNY Upstate Medical Center	Syracuse	New York
United States	Tampa Bay Health Care	Tampa	Florida
United States	Hope Research Institute LLC	Tempe	Arizona
United States	Voyage Medical	Tempe	Arizona
United States	Clinical Trials Management Services, LLC	Thousand Oaks	California
United States	DM Clinical Research	Tomball	Texas
United States	Del Sol Research Management - ClinEdge - PPDS	Tucson	Arizona
United States	Noble Clinical Research	Tucson	Arizona
United States	The Institute for Liver Health-Tucson	Tucson	Arizona
United States	Tucson Neuroscience Research - M3 WR - ERN - PPDS	Tucson	Arizona
United States	Bayview Research Group	Valley Village	California
United States	Crossroads Clinical Research (Victoria)	Victoria	Texas
United States	Emerson Clinical Research Institute LLC - Kennedy St	Washington	District of Columbia
United States	ClinPoint Trials LLC	Waxahachie	Texas
United States	Next Level Clinical Trials	West Covina	California
United States	Velocity Clinical Research	West Jordan	Utah
United States	Paradigm Clinical Research Institute Inc - ClinEdge	Wheat Ridge	Colorado
United States	Tekton Research - Oklahoma - Platinum	Yukon	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Estonia,  Finland,  France,  Germany,  Israel,  Italy,  Japan,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Number of Participants With Solicited Adverse Reactions (ARs)		Up to 176 days (7 days after each injection)
Primary	Number of Participants With Unsolicited Adverse Events (AEs)		Up to 197 days (28 days after each injection)
Primary	Number of Participants With Medically-Attended Adverse Events (MAAEs)		Day 1 through 6 months after the last injection (up to 347 days)
Primary	Number of Participants With Adverse Event of Special Interests (AESIs) and Serious Adverse Events (SAEs)		Day 1 through Day 887
Primary	Geometric Mean Titers (GMTs) of Antigen-Specific Neutralizing Antibody (nAb)		Month 30 up to Month 54
Primary	Geometric Mean Concentration (GMC) of Binding Antibody		Month 30 up to Month 54
Primary	Seroconversion From a Negative to a Positive Result for Serum IgG Against Antigens not Encoded by mRNA-1647		Day 887 up to Day 1607
Secondary	GMTs of Antigen-Specific nAb		Day 1, Months 3, 7, 12, 18, 24, and 30
Secondary	GMC of Antigen-Specific Binding Antibody		Day 1, Months 3, 7, 12, 18, 24, and 30
Secondary	Number of Participants with AEs leading to Study Discontinuation, SAEs and Deaths		Day 887 through end of study (up to Day 1607)