History of Changes for Study: NCT05085366

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

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Study Record Versions

Version	Submitted Date	Changes
1	October 7, 2021	None (earliest Version on record)
2	October 27, 2021	Recruitment Status, Contacts/Locations and Study Status
3	October 29, 2021	Eligibility and Study Status
4	November 12, 2021	Study Status and Contacts/Locations
5	December 1, 2021	Contacts/Locations and Study Status
6	December 15, 2021	Contacts/Locations and Study Status
7	February 10, 2022	Contacts/Locations and Study Status
8	March 15, 2022	Contacts/Locations and Study Status
9	April 10, 2022	Contacts/Locations and Study Status
10	May 26, 2022	Study Status and Contacts/Locations
11	June 28, 2022	Contacts/Locations and Study Status
12	August 31, 2022	Study Status and Eligibility
13	October 5, 2022	Contacts/Locations and Study Status
14	November 10, 2022	Contacts/Locations and Study Status
15	January 13, 2023	Study Status, Contacts/Locations, Eligibility and Study Design
16	February 6, 2023	Contacts/Locations and Study Status
17	April 13, 2023	Contacts/Locations and Study Status
18	May 17, 2023	Contacts/Locations and Study Status
19	July 10, 2023	Contacts/Locations and Study Status
20	October 6, 2023	Contacts/Locations, Study Status, Eligibility, Outcome Measures and Study Design
21	November 17, 2023	Recruitment Status, Study Status and Contacts/Locations
22	April 19, 2024	Outcome Measures, Study Design, Study Status, Contacts/Locations, Eligibility, Study Description and Study Identification

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	mRNA-1647-P301
Brief Title:	A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age
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
Secondary IDs:	2020-006051-17 [EudraCT Number]

Study Status


Record Verification:	October 2021
Overall Status:	Not yet recruiting
Study Start:	October 25, 2021
Primary Completion:	January 29, 2023 [Anticipated]
Study Completion:	July 29, 2025 [Anticipated]

First Submitted:	October 7, 2021
First Submitted that Met QC Criteria:	October 7, 2021
First Posted:	October 20, 2021 [Actual]

Last Update Submitted that Met QC Criteria:	October 7, 2021
Last Update Posted:	October 20, 2021 [Actual]

Sponsor/Collaborators


Sponsor:	ModernaTX, Inc.
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description


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.
Detailed Description:

Conditions


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

Study Design


Study Type:	Interventional
Primary Purpose:	Prevention
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	6900 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: mRNA-1647 Participants will receive mRNA-1647 vaccine by intramuscular (IM) injection on Day 1, Day 57, and Day 169.	Biological: mRNA-1647 Lyophilized product that is reconstituted with 0.9% sodium chloride (normal saline)
Placebo Comparator: Placebo Participants will receive mRNA-1647 vaccine matching placebo by IM injection on Day 1, Day 57, and Day 169.	Biological: Placebo 0.9% sodium chloride (normal saline) injection

Outcome Measures


Primary Outcome Measures:
1.	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) ]
2.	Number of Participants With Solicited Adverse Reactions (ARs) [ Time Frame: Up to 176 days (7 days after each injection) ]
3.	Number of Participants With Unsolicited Adverse Events (AEs) [ Time Frame: Up to 197 days (28 days after each injection) ]
4.	Number of Participants With Medically-Attended Adverse Events (MAAEs) [ Time Frame: 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) [ Time Frame: Day 1 through end of study (up to Day 887) ]
Secondary Outcome Measures:
1.	Geometric Mean Titers (GMTs) of Antigen-Specific Neutralizing Antibody (nAb) and Binding Antibody [ Time Frame: Day 1, Months 3, 7, 12, 18, 24, and 30 ]

Eligibility


Minimum Age:	16 Years
Maximum Age:	40 Years
Sex:	Female
Gender Based:
Accepts Healthy Volunteers:	Yes
Criteria:	Key Inclusion Criteria: Participants aged ≥20 years, has or anticipates having direct exposure (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. Has a body mass index of 15-35 kilograms (kg)/square meter (m^2), inclusive. Female participants: Urine pregnancy test is negative at Screening and negative on the day of the first injection (Day 1). If the participant is sexually active, has practiced adequate contraception 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). Key Exclusion Criteria: Female participant is of non-childbearing potential. 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 any study injection. Exceptions include any COVID-19 vaccines (regardless of manufacturer) may be administered >7 days but preferably >28 days after any study injection, with the intention of prioritizing COVID-19 vaccination over all other considerations; and 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. 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.

Contacts/Locations


Central Contact Person:	Moderna Clinical Trials Telephone: 877-913-3286 Email: clinicaltrials@modernatx.com
Locations:	United States, Arizona
	MedPharmics - Platinum - PPDS Phoenix, Arizona, United States, 85015-1105
	Hope Clinical Research Phoenix, Arizona, United States, 85018
	United States, California
	Velocity Clinical Research - Banning Banning, California, United States, 92220
	Velocity Clinical Research - Chula Vista - ERN - PPDS Chula Vista, California, United States, 91911-6617
	Velocity Clinical Research - San Diego La Mesa, California, United States, 91942
	United States, Colorado
	Lynn Institute of The Rockies - ERN - PPDS Colorado Springs, Colorado, United States, 32132-2720
	United States, Connecticut
	Clinical Research Consultants Incorporated Milford, Connecticut, United States, 06460-4647
	United States, Florida
	Riverside Clinical Research Edgewater, Florida, United States, 32132-2720
	United States, Georgia
	Clinical Research Atlanta - ERN-PPDS Stockbridge, Georgia, United States, 30281-9054
	United States, Louisiana
	MedPharmics - Platinum - PPDS Metairie, Louisiana, United States, 70006-4151
	United States, Maryland
	Meridian Clinical Research-(Rockville Maryland) - Platinum - PPDS Rockville, Maryland, United States, 20854-2957
	United States, Mississippi
	MedPharmics Gulfport, Mississippi, United States, 39502
	MediSync Clinical Research Hattiesburg Clinic Petal, Mississippi, United States, 39465-2932
	United States, Nebraska
	Meridian Clinical Research (Grand Island) - Platinum - PPDS Grand Island, Nebraska, United States, 68803-4327
	Meridian Clinical Research (Hastings, Nebraska) - Platinum - PPDS Hastings, Nebraska, United States, 68901-2615
	Meridian Clinical Research (Norfolk-Nebraska) - Platinum - PPDS Norfolk, Nebraska, United States, 68701-2669
	Meridian Clinical Research-(Omaha Nebraska) - Platinum - PPDS Omaha, Nebraska, United States, 68134
	United States, New Mexico
	MedPharmics, LLC. - Albuquerque Albuquerque, New Mexico, United States, 87102-3644
	United States, New York
	Meridian Clinical Research (Endwell-New York) Binghamton, New York, United States, 13901-1046
	United States, Ohio
	Sterling Research Group, Ltd. Cincinnati, Ohio, United States, 45219-2975
	ClinOhio Research Services Columbus, Ohio, United States, 43213-4440
	United States, Oklahoma
	Lynn Health Science Institute Oklahoma City, Oklahoma, United States, 73112
	United States, South Carolina
	Coastal Carolina Research Center North Charleston, South Carolina, United States, 29405
	United States, Texas
	Velocity Clinical Research - Austin Cedar Park, Texas, United States, 78613-3936
	United States, Virginia
	Health Research of Hampton Roads Inc. Newport News, Virginia, United States, 23606
	York Clinical Research Norfolk, Virginia, United States, 23510-2014

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