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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 belowTimeline
Screening ~ 7 days1 visit
Treatment ~ 6 months3 visits
Follow Up ~ 24 months11 visits
Screening ~ 7 days
Treatment ~ 6 months
Follow Up ~24 months
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 moreSecondary 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
113 Previous Clinical Trials
61,454,664 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Are you female?Has the potential participant not participated in another clinical research trial within the past month?Is the potential participant currently not pregnant or not planning to become pregnant within the next 9 months?What is the potential participant’s age?
Research Study Groups:
This trial has the following groups:- Group 1: mRNA-1647
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 7 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 6 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 24 Months after you stop receiving the treatment.
Cytomegalovirus Patient Testimony for trial: Trial Name: NCT05085366 — Phase 3
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