Stopped: The Sponsor decided to terminate the study after it did not meet the primary efficacy endpoint at final analysis. The safety profile was consistent with prior studies, and no safety concerns were raised by the Data and Safety Monitoring Board.
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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Seroconversion From a Negative to a Positive Result for Serum Immunoglobulin G (IgG) Against Antigens not Encoded by mRNA-1647
Timeframe: Day 197 (28 days after the third injection) up to Day 887 (24 months after the third injection)
Number of Participants With Solicited Adverse Reactions (ARs)
Timeframe: Up to 176 days (7 days after each injection)
Number of Participants With Unsolicited Adverse Events (AEs)
Timeframe: Up to 197 days (28 days after each injection)
Number of Participants With Medically-Attended Adverse Events (MAAEs)
Timeframe: Day 1 through 6 months after the last injection (up to 347 days)
Number of Participants With Adverse Event of Special Interests (AESIs) and Serious Adverse Events (SAEs)
Timeframe: Day 1 through Month 30
Geometric Mean Titers (GMTs) of Antigen-Specific Neutralizing Antibody (nAb)
Timeframe: Month 30 up to Month 54
Geometric Mean Concentration (GMC) of Binding Antibody
Timeframe: Month 30 up to Month 54
Seroconversion From a Negative to a Positive Result for Serum IgG Against Antigens not Encoded by mRNA-1647
Timeframe: Month 30 up to Month 54
Number of Participants With Systemic Viral Dissemination
Timeframe: Month 30 up to Month 54