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Virus Therapy

CMV Vaccine for Cytomegalovirus

Phase 3
Waitlist Available
Research Sponsored by ModernaTX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
What is the potential participant’s age?
Are you female?
Timeline
Screening 7 days
Treatment 6 months
Follow Up 24 months
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new vaccine called mRNA-1647, which aims to protect against CMV. It focuses on women who have never had CMV before. The vaccine works by teaching the body to recognize and fight the virus.

Eligible Conditions
  • Cytomegalovirus

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 7 days
Treatment ~ 6 months
Follow Up ~24 months
This trial's timeline: 7 days for screening, 6 months for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Adverse Event of Special Interests (AESIs) and Serious Adverse Events (SAEs)
Number of Participants With Medically-Attended Adverse Events (MAAEs)
Number of Participants With Solicited Adverse Reactions (ARs)
+2 more
Secondary study objectives
Geometric Mean Titers (GMTs) of Antigen-Specific Neutralizing Antibody (nAb) and Binding Antibody

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: mRNA-1647Experimental Treatment1 Intervention
Participants will receive mRNA-1647 vaccine by intramuscular (IM) injection on Day 1, Day 57, and Day 169.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive mRNA-1647 vaccine matching placebo by IM injection on Day 1, Day 57, and Day 169.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1647
2021
Completed Phase 2
~510

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
118 Previous Clinical Trials
61,577,939 Total Patients Enrolled

Media Library

mRNA-1647 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05085366 — Phase 3
Cytomegalovirus Research Study Groups: mRNA-1647, Placebo
Cytomegalovirus Clinical Trial 2023: mRNA-1647 Highlights & Side Effects. Trial Name: NCT05085366 — Phase 3
mRNA-1647 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05085366 — Phase 3
Cytomegalovirus Patient Testimony for trial: Trial Name: NCT05085366 — Phase 3
~2204 spots leftby Apr 2026
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