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NCT05085366 (mRNA-1647 in Cytomegalovirus Infection): BVCT ex-ante prediction vs. reported outcome

On 14 May 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 22 Oct 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05085366
Acronym
CMVictory
Drug Name
mRNA-1647
Drug MoA
mRNA vaccine for Cytomegalovirus
Drug Modality
Vaccine
Drug Class
First-In-Class
Therapeutic Area
Infections
Indication
Cytomegalovirus Infection
Human Patients
7454
Sponsor
ModernaTX
Phase
Phase 3

Prediction of , index 843

Prospective Prediction
Prediction Index
843
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
partial SUCCESS (statistically maybe significant yet very weak clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
526 days in advance
Readout Data Interpretation
mRNA-1647 failed to meet the primary efficacy endpoint of preventing CMV infection compared with placebo and further development has been discontinued
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

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
Phase
Phase 3
Status
Terminated
Enrollment
7454
Lead sponsor
ModernaTX, Inc.
Conditions
Cytomegalovirus Infection
Interventions
BIOLOGICAL: mRNA-1647; BIOLOGICAL: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Prevention
Start
2021-10-26
Primary completion
2025-11-04
Completion
2025-11-04
Primary outcomes
  • Seroconversion From a Negative to a Positive Result for Serum Immunoglobulin G (IgG) Against Antigens not Encoded by mRNA-1647 (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) (Up to 176 days (7 days after each injection))
  • Number of Participants With Unsolicited Adverse Events (AEs) (Up to 197 days (28 days after each injection))
  • Number of Participants With Medically-Attended Adverse Events (MAAEs) (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) (Day 1 through Month 30)

NCT05085366 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials