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
Location: See all (21) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: t
View:
• Is generally healthy based on medical history and physical examination.
Locations
Other Locations
Malaysia
Hospital Ampang ( Site 0028)
RECRUITING
Ampang
Hospital Tunku Azizah-Paediatric ( Site 0022)
RECRUITING
Kuala Lumpur
University Malaya Medical Centre-Department of Paediatrics ( Site 0025)
RECRUITING
Lembah Pantai
Sunway Medical Centre ( Site 0027)
RECRUITING
Petaling Jaya
Hospital Sibu ( Site 0021)
RECRUITING
Sibu
Philippines
Health Index Multispecialty And Lying-In Clinic ( Site 0042)
RECRUITING
Bacoor
Chong Hua Hospital ( Site 0051)
RECRUITING
Cebu City
Norzel Medical and Diagnostic Clinic Foundation Corp ( Site 0044)
RECRUITING
Cebu City
West Visayas State University Medical Center ( Site 0045)
ACTIVE_NOT_RECRUITING
Iloilo City
Philippine General Hospital ( Site 0041)
RECRUITING
Manila
University of the Philippines Manila ( Site 0047)
RECRUITING
Metro Manila
Singapore
KK Women's and Children's Hospital ( Site 0002)
RECRUITING
Singapore
National University Hospital-Paediatrics ( Site 0001)
RECRUITING
Singapore
Tan Tock Seng Hospital ( Site 0003)
RECRUITING
Singapore
Thailand
Faculty of Medicine - Khon Kaen University-Pediatrics ( Site 0064)
RECRUITING
Amphoe Mueang
Chulalongkorn University-Pediatrics ( Site 0063)
RECRUITING
Bangkok
Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0065)
RECRUITING
Bangkok
Faculty of Tropical Medicine, Mahidol University ( Site 0062)
RECRUITING
Bangkok
Songklanagarind hospital-Department of Pediatrics ( Site 0061)
RECRUITING
Hat Yai
Thammasat University Hospital-Department of Pediatrics ( Site 0068)
RECRUITING
Khong Luang
Faculty of Tropical Medicine, Mahidol University - Vaccine Trial Centre ( Site 0067)
RECRUITING
Ratchathewi
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-06-11
Estimated Completion Date: 2032-02-02
Participants
Target number of participants: 12000
Treatments
Experimental: V181
Participants will receive a single 0.5 mL subcutaneous (SC) dose of V181 on Day 1.
Placebo_comparator: Placebo
Participants will receive a single 0.5 mL SC dose of placebo on Day 1.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC