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Study identifier: NCT05085366 Synced from ClinicalTrials.gov · August 06, 2026
● Study status: Terminated

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

Condition: Cytomegalovirus Infection  ·  Sponsor: ModernaTX, Inc.

PhasePhase 3
Planned participants7454
Who can joinFemale, 16 Years to 40 Years
Healthy volunteersYes

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

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Locations (296)

Central Research Associates IncBirmingham, Alabama, United States
Accel Research Site - Achieve - Birmingham - ERN - PPDSBirmingham, Alabama, United States
SEC Clinical Research LLC - Dothan - ClinEdge - PPDSDothan, Alabama, United States
Lakeview Clinical ResearchGuntersville, Alabama, United States
Chandler Clinical Trials, LLCChandler, Arizona, United States
Arizona Clinical TrialsMesa, Arizona, United States
Phoenix Clinical LLCPhoenix, Arizona, United States
MedPharmics, LLCPhoenix, Arizona, United States
Hope Research Institute LLCPhoenix, Arizona, United States
Hope Research Institute LLCPhoenix, Arizona, United States
Epic Medical Research ArizonaSurprise, Arizona, United States
Voyage MedicalTempe, Arizona, United States

+ 284 more locations — full list on the registry record.

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