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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Cytomegalovirus Infection

In brief

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.

Key facts

Study ID
NCT05085366
Run by
ModernaTX, Inc.
People needed
7454
Starts
2021-10-26
Expected to finish
2025-11-04
Last updated by the study team
2025-12-15

Who can join

Age: 16 and older, up to 40. Sex: female. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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