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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.
Age
16 - 40 years
Sex
FEMALE
Healthy Volunteers
Yes
Central Research Associates Inc
Birmingham, Alabama, United States
Accel Research Site - Achieve - Birmingham - ERN - PPDS
Birmingham, Alabama, United States
SEC Clinical Research LLC - Dothan - ClinEdge - PPDS
Dothan, Alabama, United States
Lakeview Clinical Research
Guntersville, Alabama, United States
Chandler Clinical Trials, LLC
Chandler, Arizona, United States
Arizona Clinical Trials
Mesa, Arizona, United States
Phoenix Clinical LLC
Phoenix, Arizona, United States
MedPharmics, LLC
Phoenix, Arizona, United States
Hope Research Institute LLC
Phoenix, Arizona, United States
Hope Research Institute LLC
Phoenix, Arizona, United States
Start Date
October 26, 2021
Primary Completion Date
November 4, 2025
Completion Date
November 4, 2025
Last Updated
December 15, 2025
7,454
ACTUAL participants
mRNA-1647
BIOLOGICAL
Placebo
BIOLOGICAL
Lead Sponsor
ModernaTX, Inc.
NCT07294547
NCT06926894
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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