Actively Recruiting
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
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-12
12000
Participants Needed
40
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, immune response, and effectiveness of the V181 dengue vaccine in healthy children aged 2 to 17 years. This study aims to show that V181 can reduce the number of confirmed dengue cases caused by any of the four dengue virus types, regardless of whether participants had prior dengue exposure. The trial is a Phase 3, randomized, double-blind, placebo-controlled study sponsored by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive a single 0.5 mL subcutaneous dose of either the V181 vaccine or a placebo on Day 1. About 3600 participants will be monitored for immune response and safety for 28 days after vaccination in the Reactogenicity and Immunogenicity Subset. A smaller group of approximately 620 participants will be followed up to 5 years to evaluate long-term immune responses using virus neutralization tests. During the study, participants will be regularly assessed for adverse events, including injection site reactions and systemic symptoms, up to 28 days after vaccination and for serious adverse events up to 5 years. The study will track occurrences of dengue infections requiring medical attention and hospitalizations over approximately 3 to 5 years. Researchers will also measure antibody levels and immune responses at multiple time points. Participation involves follow-up visits and monitoring for up to 5 years after vaccination.
CONDITIONS
Brief Title
A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Is generally healthy based on medical history and physical examination
- Is between 2 and 17 years old
- Has not received any dengue vaccine before
- Is willing to comply with study procedures and follow-up
You will not qualify if you...
- Has known or suspected immune system problems
- Has history of congenital or acquired immunodeficiency
- Has documented HIV infection or is breastfeeding from a mother with HIV
- Has history of hepatitis B or C infection
- Has a bleeding disorder preventing subcutaneous vaccination or repeated blood draws
- Has serious or progressive diseases such as cancer, uncontrolled diabetes, severe heart, kidney or liver failure, or autoimmune or neurological disorders
- Has known neurological or cognitive behavioral disorders including encephalitis, acute disseminating encephalomyelitis, or pervasive development disorders
- Has received systemic corticosteroids within 30 days before vaccination or may require them within 28 days after
- Has received blood transfusions or blood products within 6 months before vaccination or plans to receive them within 28 days after
- Has received immunosuppressive therapies within 6 months before vaccination or plans to receive them within 28 days after vaccination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single subcutaneous dose of either the V181 dengue vaccine or placebo on Day 1.
1 vaccination visit (in-person)
Duration - Up to approximately 5 years
Participants are monitored for safety and immune response following vaccination, including reactogenicity assessments up to 28 days, medically attended adverse events up to 6 months, and long-term safety and efficacy evaluations up to 5 years postvaccination.
Regular visits for immunogenicity and safety assessments, including approximately 28 days for short-term follow-up and extended visits up to 5 years for long-term monitoring
Trial Site Locations
Total: 40 locations
1
Jatinegara Primary Health Center ( Site 0102)
East Jakarta, Jakarta Special Capital Region, Indonesia, 13310
Actively Recruiting
2
Cipayung Primary Health Center ( Site 0105)
East Jakarta, Jakarta Special Capital Region, Indonesia, 13840
Actively Recruiting
3
Dr Cipto Mangunkusumo Hospital-Pediatrics ( Site 0101)
Jakarta, Jakarta Special Capital Region, Indonesia, 10430
Actively Recruiting
4
Kelapa Gading Primary Health Center ( Site 0104)
North Jakarta, Jakarta Special Capital Region, Indonesia, 14240
Actively Recruiting
5
Pasar Minggu Primary Health Center ( Site 0103)
South Jakarta, Jakarta Special Capital Region, Indonesia, 12620
Actively Recruiting
6
Hospital Pakar Kanak - Kanak UKM (HPKK) ( Site 0024)
Cheras, Kuala Lumpur, Malaysia, 56000
Completed
7
University Malaya Medical Centre-Department of Paediatrics ( Site 0025)
Lembah Pantai, Kuala Lumpur, Malaysia, 59100
Actively Recruiting
8
Hospital Sibu ( Site 0021)
Sibu, Sarawak, Malaysia, 96000
Actively Recruiting
9
Hospital Ampang ( Site 0028)
Ampang, Selangor, Malaysia, 68000
Actively Recruiting
10
Hospital Al-Sultan Abdullah - Universiti Teknologi MARA ( Site 0029)
Bandar Puncak Alam, Selangor, Malaysia, 42300
Completed
11
Sunway Medical Centre ( Site 0027)
Petaling Jaya, Selangor, Malaysia, 47500
Actively Recruiting
12
Hospital Tunku Azizah-Paediatric ( Site 0022)
Kuala Lumpur, Malaysia, 50300
Actively Recruiting
13
Health Index Multispecialty And Lying-In Clinic ( Site 0042)
Bacoor, Cavite, Philippines, 4102
Actively Recruiting
14
Chong Hua Hospital ( Site 0051)
Cebu City, Cebu, Philippines, 6000
Actively Recruiting
15
Norzel Medical and Diagnostic Clinic Foundation Corp ( Site 0044)
Cebu City, Central Visayas (Region VII), Philippines, 6000
Actively Recruiting
16
West Visayas State University Medical Center ( Site 0045)
Iloilo City, Iloilo, Philippines, 5000
Active, Not Recruiting
17
Philippine General Hospital ( Site 0041)
Manila, National Capital Region, Philippines, 1000
Actively Recruiting
18
University of the Philippines Manila ( Site 0047)
Metro Manila, National Capital Region, Philippines, 1000
Actively Recruiting
19
Clinical Research Investigator Group ( Site 0110)
Bayamón, Puerto Rico, 00960
Actively Recruiting
20
San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0114)
Caguas, Puerto Rico, 00726
Actively Recruiting
21
Ponce Medical School Foundation Inc./CAIMED Center ( Site 0112)
Ponce, Puerto Rico, 00716
Actively Recruiting
22
Latin Clinical Trial Center ( Site 0113)
San Juan, Puerto Rico, 00909
Actively Recruiting
23
Wellness clinical Research Vega Baja ( Site 0116)
Vega Baja, Puerto Rico, 00693
Actively Recruiting
24
National University Hospital-Paediatrics ( Site 0001)
Singapore, Central Singapore, Singapore, 119074
Actively Recruiting
25
KK Women's and Children's Hospital ( Site 0002)
Singapore, Central Singapore, Singapore, 229899
Actively Recruiting
26
Tan Tock Seng Hospital ( Site 0003)
Singapore, Central Singapore, Singapore, 308433
Actively Recruiting
27
Chulalongkorn University-Pediatrics ( Site 0063)
Bangkok, Bangkok, Thailand, 10330
Actively Recruiting
28
Faculty of Tropical Medicine, Mahidol University ( Site 0062)
Bangkok, Bangkok, Thailand, 10400
Actively Recruiting
29
Queen Sirikit National Institute of Child Health-Pediatric Infectious Disease ( Site 0071)
Bangkok, Bangkok, Thailand, 10400
Actively Recruiting
30
Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0065)
Bangkok, Bangkok, Thailand, 10700
Active, Not Recruiting
31
Faculty of Tropical Medicine, Mahidol University - Vaccine Trial Centre ( Site 0067)
Ratchathewi, Bangkok, Thailand, 10400
Actively Recruiting
32
Faculty of Medicine - Khon Kaen University-Pediatrics ( Site 0064)
Amphoe Mueang, Changwat Khon Kaen, Thailand, 40002
Actively Recruiting
33
Thammasat University Hospital-Department of Pediatrics ( Site 0068)
Khong Luang, Changwat Pathum Thani, Thailand, 12120
Actively Recruiting
34
Songklanagarind hospital-Department of Pediatrics ( Site 0061)
Hat Yai, Changwat Songkhla, Thailand, 90110
Actively Recruiting
35
Maharaj Nakorn Chiang Mai Hospital ( Site 0066)
Chiang Mai, Thailand, 50200
Actively Recruiting
36
Kien Giang Women's and Children hospital ( Site 0091)
Rach Gia, An Giang, Vietnam, 920 000
Actively Recruiting
37
Cai Lay Regional General Hospital ( Site 0093)
Cai Lậy, Tien Giang, Vietnam, 860 000
Actively Recruiting
38
Quang Nam Hospital for Women and Children ( Site 0094)
Da Nang, Vietnam, 550000
Actively Recruiting
39
Dong Thap General Hospital ( Site 0092)
Dong Thập, Vietnam, 810000
Actively Recruiting
40
Pasteur Institute in Ho Chi Minh city ( Site 0089)
Ho Chi Minh City, Vietnam, 70000
Actively Recruiting
Research Team
T
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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