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

NCT ID: NCT07013487

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

12000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-11

Study Completion Date

2032-02-02

Brief Summary

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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

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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V181

Participants will receive a single 0.5 mL subcutaneous (SC) dose of V181 on Day 1.

Group Type EXPERIMENTAL

V181

Intervention Type BIOLOGICAL

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Participants will receive a single 0.5 mL SC dose of placebo on Day 1.

Interventions

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V181

Participants will receive a single 0.5 mL SC dose of V181 on Day 1.

Intervention Type BIOLOGICAL

Placebo

Participants will receive a single 0.5 mL SC dose of placebo on Day 1.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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).
* 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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Jatinegara Primary Health Center ( Site 0102)

East Jakarta, Jakarta Special Capital Region, Indonesia

Site Status RECRUITING

Cipayung Primary Health Center ( Site 0105)

East Jakarta, Jakarta Special Capital Region, Indonesia

Site Status RECRUITING

Dr Cipto Mangunkusumo Hospital-Pediatrics ( Site 0101)

Jakarta, Jakarta Special Capital Region, Indonesia

Site Status RECRUITING

Kelapa Gading Primary Health Center ( Site 0104)

North Jakarta, Jakarta Special Capital Region, Indonesia

Site Status RECRUITING

Pasar Minggu Primary Health Center ( Site 0103)

South Jakarta, Jakarta Special Capital Region, Indonesia

Site Status RECRUITING

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

Lembah Pantai, Kuala Lumpur, Malaysia

Site Status RECRUITING

Hospital Sibu ( Site 0021)

Sibu, Sarawak, Malaysia

Site Status RECRUITING

Hospital Ampang ( Site 0028)

Ampang, Selangor, Malaysia

Site Status RECRUITING

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

Bandar Puncak Alam, Selangor, Malaysia

Site Status COMPLETED

Sunway Medical Centre ( Site 0027)

Petaling Jaya, Selangor, Malaysia

Site Status RECRUITING

Hospital Tunku Azizah-Paediatric ( Site 0022)

Kuala Lumpur, , Malaysia

Site Status RECRUITING

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

Bacoor, Cavite, Philippines

Site Status RECRUITING

Chong Hua Hospital ( Site 0051)

Cebu City, Cebu, Philippines

Site Status RECRUITING

Norzel Medical and Diagnostic Clinic Foundation Corp ( Site 0044)

Cebu City, Central Visayas (Region VII), Philippines

Site Status RECRUITING

West Visayas State University Medical Center ( Site 0045)

Iloilo City, Iloilo, Philippines

Site Status ACTIVE_NOT_RECRUITING

Philippine General Hospital ( Site 0041)

Manila, National Capital Region, Philippines

Site Status RECRUITING

University of the Philippines Manila ( Site 0047)

Metro Manila, National Capital Region, Philippines

Site Status RECRUITING

National University Hospital-Paediatrics ( Site 0001)

Singapore, Central Singapore, Singapore

Site Status RECRUITING

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

Singapore, Central Singapore, Singapore

Site Status RECRUITING

Tan Tock Seng Hospital ( Site 0003)

Singapore, Central Singapore, Singapore

Site Status RECRUITING

Chulalongkorn University-Pediatrics ( Site 0063)

Bangkok, Bangkok, Thailand

Site Status RECRUITING

Faculty of Tropical Medicine, Mahidol University ( Site 0062)

Bangkok, Bangkok, Thailand

Site Status RECRUITING

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

Bangkok, Bangkok, Thailand

Site Status RECRUITING

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

Bangkok, Bangkok, Thailand

Site Status RECRUITING

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

Ratchathewi, Bangkok, Thailand

Site Status RECRUITING

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

Amphoe Mueang, Changwat Khon Kaen, Thailand

Site Status RECRUITING

Thammasat University Hospital-Department of Pediatrics ( Site 0068)

Khong Luang, Changwat Pathum Thani, Thailand

Site Status RECRUITING

Songklanagarind hospital-Department of Pediatrics ( Site 0061)

Hat Yai, Changwat Songkhla, Thailand

Site Status RECRUITING

Maharaj Nakorn Chiang Mai Hospital ( Site 0066)

Chiang Mai, , Thailand

Site Status RECRUITING

Countries

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Indonesia Malaysia Philippines Singapore Thailand

Central Contacts

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Toll Free Number

Role: CONTACT

Phone: 1-888-577-8839

Email: [email protected]

Facility Contacts

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Study Coordinator

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Related Links

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https://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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MOBILIZE-1

Identifier Type: OTHER

Identifier Source: secondary_id

2022-003483-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V181-005

Identifier Type: -

Identifier Source: org_study_id