A Study of mRNA-1647 Cytomegalovirus Vaccine in Healthy Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age
NCT05575492 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 873
Last updated 2025-12-15
Summary
The main purpose of study is to evaluate the safety and immunogenicity of different dose levels of mRNA-1647 versus control in healthy cytomegalovirus (CMV)-seronegative and CMV-seropositive female and male participants 9 to 15 years of age. In addition, mRNA-1647 will be evaluated in female participants 16 to 25 years as a comparator cohort.
Conditions
- Cytomegalovirus
Interventions
- BIOLOGICAL
-
mRNA-1647
Sterile liquid for injection
- OTHER
-
Placebo
0.9% sodium chloride injection (normal saline)
Sponsors & Collaborators
-
ModernaTX, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 9 Years
- Max Age
- 25 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-11-07
- Primary Completion
- 2027-01-15
- Completion
- 2027-01-15
- FDA Drug
- Yes
Countries
- United States
- Canada
- United Kingdom
Study Locations
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