NCT05575492

A Study of mRNA-1647 Cytomegalovirus Vaccine in Healthy Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age

A Phase 1/2a Open-Label Dose-Ranging and Observer-Blind Placebo-Controlled, Safety and Immunogenicity Study of mRNA-1647 Cytomegalovirus Vaccine in Female and Male Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 873 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 9 Years – 25 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study will be conducted in 2 parts: Part 1 Dose-Ranging and Part 2 Safety Expansion.

Conditions

• Cytomegalovirus

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-1647	Sterile liquid for injection
OTHER	Placebo	0.9% sodium chloride injection (normal saline)

Timeline

• Start date: 2022-11-07
• Primary completion: 2027-01-15
• Completion: 2027-01-15
• First posted: 2022-10-12
• Last updated: 2025-12-15

Locations

57 sites across 3 countries: United States, Canada, United Kingdom

Regulatory

• FDA-regulated drug study