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NCT05085366 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age
A Phase 3 study, sponsored by ModernaTX.
- Terminated
- Registry status
- Phase 3
- Development phase
- 7,454
- Enrollment target
NCT05085366 is a Phase 3 study that was terminated before completion, run by ModernaTX. The registered enrollment target is 7,454 participants.
The verdict
NCT05085366, a Phase 3 study, was terminated before completion, sponsored by ModernaTX.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 7,454 participants
- Enrollment target
Study Summary
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.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL mRNA-1647
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7,454 participants |
| Start Date | 2021-10-26 |
| Est. Completion | 2025-11-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05085366
The ClinicalTrials.gov registry entry for NCT05085366 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 7,454 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ModernaTX, which has 90 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05085366 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05085366 about?
NCT05085366 is a clinical study titled "A 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 mai...
What is the current status of trial NCT05085366?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 7,454 participants. The study started on 2021-10-26. Estimated completion is 2025-11-04.
What interventions are being tested in trial NCT05085366?
The interventions under investigation include: Placebo (BIOLOGICAL), mRNA-1647 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05085366?
This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.
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