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

NCT07013487 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: V181-005MOBILIZE-12022-003483-25
• Study Type: interventional
• Target: 12,000
• Locations: 7 countries
• Sites: 39

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants Experiencing a Medically Attended Adverse Event (MAAE)

  A MAAE is an adverse event (AE) in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an ER visit, office visit, or an urgent care visit with any medical personnel for any reason.

  Up to approximately 6 months postvaccination

• Percentage of Participants Experiencing a Serious Adverse Event (SAE)

  An SAE is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.

  Up to approximately 5 years postvaccination

• Reactogenicity and Immunogenicity Subset: Percentage of Participants Experiencing Solicited Injection-site AEs

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. Solicited injection-site AEs will include pain/tenderness, erythema/redness, and swelling.

  Up to approximately 5 days postvaccination

• Reactogenicity and Immunogenicity Subset: Percentage of Participants Experiencing Solicited Systemic AEs

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. Solicited systemic AEs will include rash, headache, tiredness (fatigue), muscle aches all over body (myalgia), joint pain and fever (pyrexia).

  Up to approximately 28 days postvaccination

• Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, Due to Any of the 4 Dengue Serotypes, Regardless of Dengue Serostatus at Baseline

  Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by wild type (WT) reverse transcription polymerase chain reaction (RT-PCR) or non-structural protein 1 (NS1) enzyme-linked immunosorbent assay (ELISA).

  Up to approximately 3 years postvaccination

Secondary Outcomes (38)

• Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, Due to Each of the 4 Dengue Serotypes, Regardless of Dengue Serostatus at Baseline

  Up to approximately 3 years postvaccination

• Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination

  Up to approximately 3 years postvaccination

• Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination

  Up to approximately 5 years postvaccination

• Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline

  Up to approximately 5 years postvaccination

• Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD Meeting Criteria for Warning Signs or Severe Dengue, Regardless of Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination

  Up to approximately 3 years postvaccination

Study Arms (2)

V181

EXPERIMENTAL

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

Biological: V181

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

V181 BIOLOGICAL

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

V181

Placebo BIOLOGICAL

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

Placebo

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (39)

Jatinegara Primary Health Center ( Site 0102)

East Jakarta, Jakarta Special Capital Region, 13310, Indonesia

RECRUITING

Cipayung Primary Health Center ( Site 0105)

East Jakarta, Jakarta Special Capital Region, 13840, Indonesia

RECRUITING

Dr Cipto Mangunkusumo Hospital-Pediatrics ( Site 0101)

Jakarta, Jakarta Special Capital Region, 10430, Indonesia

RECRUITING

Kelapa Gading Primary Health Center ( Site 0104)

North Jakarta, Jakarta Special Capital Region, 14240, Indonesia

RECRUITING

Pasar Minggu Primary Health Center ( Site 0103)

South Jakarta, Jakarta Special Capital Region, 12620, Indonesia

RECRUITING

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

Lembah Pantai, Kuala Lumpur, 59100, Malaysia

RECRUITING

Hospital Sibu ( Site 0021)

Sibu, Sarawak, 96000, Malaysia

RECRUITING

Hospital Ampang ( Site 0028)

Ampang, Selangor, 68000, Malaysia

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

RECRUITING

Hospital Tunku Azizah-Paediatric ( Site 0022)

Kuala Lumpur, 50300, Malaysia

RECRUITING

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

Bacoor, Cavite, 4102, Philippines

RECRUITING

Chong Hua Hospital ( Site 0051)

Cebu City, Cebu, 6000, Philippines

RECRUITING

Norzel Medical and Diagnostic Clinic Foundation Corp ( Site 0044)

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

RECRUITING

West Visayas State University Medical Center ( Site 0045)

Iloilo City, Iloilo, 5000, Philippines

ACTIVE NOT RECRUITING

Philippine General Hospital ( Site 0041)

Manila, National Capital Region, 1000, Philippines

RECRUITING

University of the Philippines Manila ( Site 0047)

Metro Manila, National Capital Region, 1000, Philippines

RECRUITING

Clinical Research Investigator Group ( Site 0110)

Bayamón, 00960, Puerto Rico

RECRUITING

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

Caguas, 00726, Puerto Rico

RECRUITING

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

Ponce, 00716, Puerto Rico

RECRUITING

Latin Clinical Trial Center ( Site 0113)

San Juan, 00909, Puerto Rico

RECRUITING

Wellness clinical Research Vega Baja ( Site 0116)

Vega Baja, 00693, Puerto Rico

RECRUITING

National University Hospital-Paediatrics ( Site 0001)

Singapore, Central Singapore, 119074, Singapore

RECRUITING

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

Singapore, Central Singapore, 229899, Singapore

RECRUITING

Tan Tock Seng Hospital ( Site 0003)

Singapore, Central Singapore, 308433, Singapore

RECRUITING

Chulalongkorn University-Pediatrics ( Site 0063)

Bangkok, Bangkok, 10330, Thailand

RECRUITING

Faculty of Tropical Medicine, Mahidol University ( Site 0062)

Bangkok, Bangkok, 10400, Thailand

RECRUITING

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

Bangkok, Bangkok, 10400, Thailand

RECRUITING

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

Bangkok, Bangkok, 10700, Thailand

ACTIVE NOT RECRUITING

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

Ratchathewi, Bangkok, 10400, Thailand

RECRUITING

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

Amphoe Mueang, Changwat Khon Kaen, 40002, Thailand

RECRUITING

Thammasat University Hospital-Department of Pediatrics ( Site 0068)

Khong Luang, Changwat Pathum Thani, 12120, Thailand

RECRUITING

Songklanagarind hospital-Department of Pediatrics ( Site 0061)

Hat Yai, Changwat Songkhla, 90110, Thailand

RECRUITING

Maharaj Nakorn Chiang Mai Hospital ( Site 0066)

Chiang Mai, 50200, Thailand

RECRUITING

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

Rach Gia, An Giang, 920 000, Vietnam

RECRUITING

Cai Lay Regional General Hospital ( Site 0093)

Cai Lậy, Tien Giang, 860 000, Vietnam

RECRUITING

Quang Nam Hospital for Women and Children ( Site 0094)

Da Nang, 550000, Vietnam

RECRUITING

Dong Thap General Hospital ( Site 0092)

Dong Thập, 810000, Vietnam

RECRUITING

Pasteur Institute in Ho Chi Minh city ( Site 0089)

Ho Chi Minh City, 70000, Vietnam

RECRUITING

Related Links

• Merck Clinical Trials Information

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 10, 2025
• Study Start: June 11, 2025
• Primary Completion (Estimated): October 24, 2031
• Study Completion (Estimated): October 24, 2031
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

SG (3); TH (9); VN (5); PR (5); MY (6); ID (5); PH (6)