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

Last updated: May 8, 2026
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

V181

Placebo

Clinical Study ID

NCT07013487
V181-005
2022-003483-25
MOBILIZE-1
  • Ages 2-17
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

The key Inclusion Criteria include but are not limited to:

  • Is generally healthy based on medical history and physical examination.

The key Exclusion Criteria include but are not limited to:

  • Has a known or suspected impairment of immunological function.

  • Has a history of congenital or acquired immunodeficiency.

  • Has a documented human immunodeficiency virus (HIV) infection or is breastfeeding from a mother with documented HIV infection.

  • Has a documented history of hepatitis B or C infection.

  • Has a bleeding disorder contraindicating subcutaneous vaccination or repeated venipuncture.

  • Has a serious or progressive disease, including but not limited to cancer, uncontrolled diabetes, severe cardiac, renal or hepatic insufficiency, or systemic autoimmune or neurologic disorders.

  • Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders.

  • Previous receipt of a dengue vaccine or plans to receive any dengue vaccine (investigational or approved) for the duration of the study (other than the study vaccine).

  • Received systemic corticosteroids <30 days before receipt of study intervention or is expected to require systemic corticosteroids ≤28 days after receipt of study intervention.

  • Has received a blood transfusion or blood products, including immunoglobulins, ≤6 months before receipt of study intervention or plans to receive a blood transfusion or blood products (including immunoglobulins) ≤28 days after receipt of study intervention.

  • Has received immunosuppressive therapies, including chemotherapeutic agents used to treat cancer or other conditions, treatments associated with organ or bone marrow transplantation, or autoimmune disease, ≤6 months before receipt of study intervention or plans to receive immunosuppressive therapies ≤28 days after receipt of study intervention.

Study Design

Total Participants: 12000
Treatment Group(s): 2
Primary Treatment: V181
Phase: 3
Study Start date:
June 11, 2025
Estimated Completion Date:
October 24, 2031

Study 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.

Connect with a study center

  • Cipayung Primary Health Center ( Site 0105)

    East Jakarta, Jakarta Special Capital Region 13840
    Indonesia

    Active - Recruiting

  • Jatinegara Primary Health Center ( Site 0102)

    East Jakarta, Jakarta Special Capital Region 13310
    Indonesia

    Active - Recruiting

  • Dr Cipto Mangunkusumo Hospital-Pediatrics ( Site 0101)

    Jakarta, Jakarta Special Capital Region 10430
    Indonesia

    Active - Recruiting

  • Kelapa Gading Primary Health Center ( Site 0104)

    North Jakarta, Jakarta Special Capital Region 14240
    Indonesia

    Active - Recruiting

  • Pasar Minggu Primary Health Center ( Site 0103)

    South Jakarta, Jakarta Special Capital Region 12620
    Indonesia

    Active - Recruiting

  • Dr Cipto Mangunkusumo Hospital-Pediatrics ( Site 0101)

    Jakarta 1642911, Jakarta Special Capital Region 1642907 10430
    Indonesia

    Site Not Available

  • Hospital Pakar Kanak - Kanak UKM (HPKK) ( Site 0024)

    Cheras, Kuala Lumpur 56000
    Malaysia

    Completed

  • University Malaya Medical Centre-Department of Paediatrics ( Site 0025)

    Lembah Pantai, Kuala Lumpur 59100
    Malaysia

    Active - Recruiting

  • Hospital Sibu ( Site 0021)

    Sibu, Sarawak 96000
    Malaysia

    Active - Recruiting

  • Hospital Sibu ( Site 0021)

    Sibu 1735902, Sarawak 1733038 96000
    Malaysia

    Site Not Available

  • Hospital Ampang ( Site 0028)

    Ampang, Selangor 68000
    Malaysia

    Active - Recruiting

  • Hospital Al-Sultan Abdullah - Universiti Teknologi MARA ( Site 0029)

    Bandar Puncak Alam, Selangor 42300
    Malaysia

    Completed

  • Sunway Medical Centre ( Site 0027)

    Petaling Jaya, Selangor 47500
    Malaysia

    Active - Recruiting

  • Hospital Al-Sultan Abdullah - Universiti Teknologi MARA ( Site 0029)

    Bandar Puncak Alam 11429145, Selangor 1733037 42300
    Malaysia

    Site Not Available

  • Sunway Medical Centre ( Site 0027)

    Petaling Jaya 1735158, Selangor 1733037 47500
    Malaysia

    Site Not Available

  • Hospital Tunku Azizah-Paediatric ( Site 0022)

    Kuala Lumpur, 50300
    Malaysia

    Active - Recruiting

  • Hospital Tunku Azizah-Paediatric ( Site 0022)

    Kuala Lumpur 1735161, 50300
    Malaysia

    Site Not Available

  • Health Index Multispecialty And Lying-In Clinic ( Site 0042)

    Bacoor, Cavite 4102
    Philippines

    Active - Recruiting

  • Health Index Multispecialty And Lying-In Clinic ( Site 0042)

    Bacoor 1729524, Cavite 4102
    Philippines

    Site Not Available

  • Chong Hua Hospital ( Site 0051)

    Cebu City, Cebu 6000
    Philippines

    Active - Recruiting

  • Chong Hua Hospital ( Site 0051)

    Cebu City 1717512, Cebu 6000
    Philippines

    Active - Recruiting

  • Norzel Medical and Diagnostic Clinic Foundation Corp ( Site 0044)

    Cebu City, Central Visayas (Region VII) 6000
    Philippines

    Active - Recruiting

  • Norzel Medical and Diagnostic Clinic Foundation Corp ( Site 0044)

    Cebu City 1717512, Central Visayas (Region VII) 6000
    Philippines

    Site Not Available

  • West Visayas State University Medical Center ( Site 0045)

    Iloilo City, Iloilo 5000
    Philippines

    Site Not Available

  • West Visayas State University Medical Center ( Site 0045)

    Iloilo City 1711005, Iloilo 5000
    Philippines

    Site Not Available

  • Philippine General Hospital ( Site 0041)

    Manila, National Capital Region 1000
    Philippines

    Active - Recruiting

  • University of the Philippines Manila ( Site 0047)

    Metro Manila, National Capital Region 1000
    Philippines

    Active - Recruiting

  • Philippine General Hospital ( Site 0041)

    Manila 1701668, National Capital Region 7521311 1000
    Philippines

    Site Not Available

  • Clinical Research Investigator Group ( Site 0110)

    Bayamón, 00960
    Puerto Rico

    Active - Recruiting

  • San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0114)

    Caguas, 00726
    Puerto Rico

    Active - Recruiting

  • Ponce Medical School Foundation Inc./CAIMED Center ( Site 0112)

    Ponce, 00716
    Puerto Rico

    Active - Recruiting

  • Latin Clinical Trial Center ( Site 0113)

    San Juan, 00909
    Puerto Rico

    Active - Recruiting

  • Wellness clinical Research Vega Baja ( Site 0116)

    Vega Baja, 00693
    Puerto Rico

    Active - Recruiting

  • KK Women's and Children's Hospital ( Site 0002)

    Singapore, Central Singapore 229899
    Singapore

    Active - Recruiting

  • National University Hospital-Paediatrics ( Site 0001)

    Singapore, Central Singapore 119074
    Singapore

    Active - Recruiting

  • Tan Tock Seng Hospital ( Site 0003)

    Singapore, Central Singapore 308433
    Singapore

    Active - Recruiting

  • KK Women's and Children's Hospital ( Site 0002)

    Singapore 1880252, Central Singapore 229899
    Singapore

    Site Not Available

  • National University Hospital-Paediatrics ( Site 0001)

    Singapore 1880252, Central Singapore 119074
    Singapore

    Active - Recruiting

  • Tan Tock Seng Hospital ( Site 0003)

    Singapore 1880252, Central Singapore 308433
    Singapore

    Active - Recruiting

  • Chulalongkorn University-Pediatrics ( Site 0063)

    Bangkok, Bangkok 10330
    Thailand

    Active - Recruiting

  • Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0065)

    Bangkok, Bangkok 10700
    Thailand

    Site Not Available

  • Faculty of Tropical Medicine, Mahidol University ( Site 0062)

    Bangkok, Bangkok 10400
    Thailand

    Active - Recruiting

  • Queen Sirikit National Institute of Child Health-Pediatric Infectious Disease ( Site 0071)

    Bangkok, Bangkok 10400
    Thailand

    Active - Recruiting

  • Faculty of Tropical Medicine, Mahidol University - Vaccine Trial Centre ( Site 0067)

    Ratchathewi, Bangkok 10400
    Thailand

    Active - Recruiting

  • Chulalongkorn University-Pediatrics ( Site 0063)

    Bangkok 1609350, Bangkok 1609348 10330
    Thailand

    Active - Recruiting

  • Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0065)

    Bangkok 1609350, Bangkok 1609348 10700
    Thailand

    Active - Recruiting

  • Faculty of Tropical Medicine, Mahidol University ( Site 0062)

    Bangkok 1609350, Bangkok 1609348 10400
    Thailand

    Active - Recruiting

  • Queen Sirikit National Institute of Child Health-Pediatric Infectious Disease ( Site 0071)

    Bangkok 1609350, Bangkok 1609348 10400
    Thailand

    Site Not Available

  • Faculty of Tropical Medicine, Mahidol University - Vaccine Trial Centre ( Site 0067)

    Ratchathewi 7026885, Bangkok 1609348 10400
    Thailand

    Site Not Available

  • Faculty of Medicine - Khon Kaen University-Pediatrics ( Site 0064)

    Amphoe Mueang, Changwat Khon Kaen 40002
    Thailand

    Active - Recruiting

  • Thammasat University Hospital-Department of Pediatrics ( Site 0068)

    Khong Luang, Changwat Pathum Thani 12120
    Thailand

    Active - Recruiting

  • Songklanagarind hospital-Department of Pediatrics ( Site 0061)

    Hat Yai, Changwat Songkhla 90110
    Thailand

    Active - Recruiting

  • Songklanagarind hospital-Department of Pediatrics ( Site 0061)

    Hat Yai 1610780, Changwat Songkhla 1606146 90110
    Thailand

    Site Not Available

  • Maharaj Nakorn Chiang Mai Hospital ( Site 0066)

    Chiang Mai, 50200
    Thailand

    Active - Recruiting

  • Maharaj Nakorn Chiang Mai Hospital ( Site 0066)

    Chiang Mai 1153671, 50200
    Thailand

    Site Not Available

  • Kien Giang Women's and Children hospital ( Site 0091)

    Rach Gia, An Giang 920 000
    Vietnam

    Active - Recruiting

  • Cai Lay Regional General Hospital ( Site 0093)

    Cai Lậy, Tien Giang 860 000
    Vietnam

    Active - Recruiting

  • Quang Nam Hospital for Women and Children ( Site 0094)

    Da Nang, 550000
    Vietnam

    Active - Recruiting

  • Dong Thap General Hospital ( Site 0092)

    Dong Thập, 810000
    Vietnam

    Active - Recruiting

  • Pasteur Institute in Ho Chi Minh city ( Site 0089)

    Ho Chi Minh City, 70000
    Vietnam

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.