NCT07013487

A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Immunogenicity, and Efficacy of V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12,000 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to demonstrate that V181 is safe and well tolerated, elicits an immune response, and reduces the frequency of virologically confirmed dengue (VCD) of any severity, due to any of the 4 dengue serotypes, regardless of dengue serostatus at baseline in children 2 to 17 years of age.

Detailed description

The Reactogenicity and Immunogenicity Subset consists of approximately 3600 participants who will be followed for immunogenicity and safety through 28 days postvaccination. The Long-term Immunogenicity Subset consists of approximately 620 participants randomly selected from the Reactogenicity and Immunogenicity Subset and will evaluate virus reduction neutralization test (VRNT) at designated timepoints up to 5 years postvaccination.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	V181	Participants will receive a single 0.5 mL SC dose of V181 on Day 1.
BIOLOGICAL	Placebo	Participants will receive a single 0.5 mL SC dose of placebo on Day 1.

Timeline

• Start date: 2025-06-11
• Primary completion: 2031-10-24
• Completion: 2031-10-24
• First posted: 2025-06-10
• Last updated: 2026-04-13

Locations

37 sites across 7 countries: Indonesia, Malaysia, Philippines, Puerto Rico, Singapore, Thailand, Vietnam

Regulatory

• FDA-regulated drug study