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A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)
Sponsor: Merck Sharp & Dohme LLC
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.
Official title: 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
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
12000
Start Date
2025-06-11
Completion Date
2031-10-24
Last Updated
2026-03-31
Healthy Volunteers
Yes
Conditions
Interventions
V181
Participants will receive a single 0.5 mL SC dose of V181 on Day 1.
Placebo
Participants will receive a single 0.5 mL SC dose of placebo on Day 1.
Locations (37)
Jatinegara Primary Health Center ( Site 0102)
East Jakarta, Jakarta Special Capital Region, Indonesia
Cipayung Primary Health Center ( Site 0105)
East Jakarta, Jakarta Special Capital Region, Indonesia
Dr Cipto Mangunkusumo Hospital-Pediatrics ( Site 0101)
Jakarta, Jakarta Special Capital Region, Indonesia
Kelapa Gading Primary Health Center ( Site 0104)
North Jakarta, Jakarta Special Capital Region, Indonesia
Pasar Minggu Primary Health Center ( Site 0103)
South Jakarta, Jakarta Special Capital Region, Indonesia
University Malaya Medical Centre-Department of Paediatrics ( Site 0025)
Lembah Pantai, Kuala Lumpur, Malaysia
Hospital Sibu ( Site 0021)
Sibu, Sarawak, Malaysia
Hospital Ampang ( Site 0028)
Ampang, Selangor, Malaysia
Hospital Al-Sultan Abdullah - Universiti Teknologi MARA ( Site 0029)
Bandar Puncak Alam, Selangor, Malaysia
Sunway Medical Centre ( Site 0027)
Petaling Jaya, Selangor, Malaysia
Hospital Tunku Azizah-Paediatric ( Site 0022)
Kuala Lumpur, Malaysia
Health Index Multispecialty And Lying-In Clinic ( Site 0042)
Bacoor, Cavite, Philippines
Chong Hua Hospital ( Site 0051)
Cebu City, Cebu, Philippines
Norzel Medical and Diagnostic Clinic Foundation Corp ( Site 0044)
Cebu City, Central Visayas (Region VII), Philippines
West Visayas State University Medical Center ( Site 0045)
Iloilo City, Iloilo, Philippines
Philippine General Hospital ( Site 0041)
Manila, National Capital Region, Philippines
University of the Philippines Manila ( Site 0047)
Metro Manila, National Capital Region, Philippines
Clinical Research Investigator Group ( Site 0110)
Bayamón, Puerto Rico
San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0114)
Caguas, Puerto Rico
Ponce Medical School Foundation Inc./CAIMED Center ( Site 0112)
Ponce, Puerto Rico
Latin Clinical Trial Center ( Site 0113)
San Juan, Puerto Rico
Wellness clinical Research Vega Baja ( Site 0116)
Vega Baja, Puerto Rico
National University Hospital-Paediatrics ( Site 0001)
Singapore, Central Singapore, Singapore
KK Women's and Children's Hospital ( Site 0002)
Singapore, Central Singapore, Singapore
Tan Tock Seng Hospital ( Site 0003)
Singapore, Central Singapore, Singapore
Chulalongkorn University-Pediatrics ( Site 0063)
Bangkok, Bangkok, Thailand
Faculty of Tropical Medicine, Mahidol University ( Site 0062)
Bangkok, Bangkok, Thailand
Queen Sirikit National Institute of Child Health-Pediatric Infectious Disease ( Site 0071)
Bangkok, Bangkok, Thailand
Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0065)
Bangkok, Bangkok, Thailand
Faculty of Tropical Medicine, Mahidol University - Vaccine Trial Centre ( Site 0067)
Ratchathewi, Bangkok, Thailand
Faculty of Medicine - Khon Kaen University-Pediatrics ( Site 0064)
Amphoe Mueang, Changwat Khon Kaen, Thailand
Thammasat University Hospital-Department of Pediatrics ( Site 0068)
Khong Luang, Changwat Pathum Thani, Thailand
Songklanagarind hospital-Department of Pediatrics ( Site 0061)
Hat Yai, Changwat Songkhla, Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 0066)
Chiang Mai, Thailand
Cai Lay Regional General Hospital ( Site 0093)
Cai Lậy, Tien Giang, Vietnam
Dong Thap General Hospital ( Site 0092)
Dong Thập, Vietnam
Pasteur Institute in Ho Chi Minh city ( Site 0089)
Ho Chi Minh City, Vietnam