HealthyPhase 3NCT07013487
A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)
A Phase 3 study testing V181 in people with Healthy, run by Merck Sharp & Dohme LLC at 41 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- V181
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12,000 participants
- Where
- 41 sitesin 7 countries
- Study dates
- 11 Jun 2025to 24 Oct 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Trial locations and contacts
41 sites in 7 countries.
41 sites in 7 countries
Thailand10 sites
Faculty of Medicine - Khon Kaen University-Pediatrics ( Site 0064)
Amphoe Mueang, Changwat Khon Kaen, 40002
Chulalongkorn University-Pediatrics ( Site 0063)
Bangkok, Bangkok, 10330
Faculty of Tropical Medicine, Mahidol University ( Site 0062)
Bangkok, Bangkok, 10400
Queen Sirikit National Institute of Child Health-Pediatric Infectious Disease ( Site 0071)
Bangkok, Bangkok, 10400
Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0065)
Bangkok, Bangkok, 10700
Songklanagarind hospital-Department of Pediatrics ( Site 0061)
Hat Yai, Changwat Songkhla, 90110
Thammasat University Hospital-Department of Pediatrics ( Site 0068)
Khong Luang, Changwat Pathum Thani, 12120
Kamphaeng Phet-AFRIMS Virology Research Unit KAVRU ( Site 0070)
Muang, Changwat Kamphaeng Phet, 62000
Maharaj Nakorn Chiang Mai Hospital ( Site 0066)
Muang, Chiang Mai, 50200
Faculty of Tropical Medicine, Mahidol University - Vaccine Trial Centre ( Site 0067)
Ratchathewi, Bangkok, 10400
Malaysia7 sites
Hospital Ampang ( Site 0028)
Ampang, Selangor, 68000
Hospital Al-Sultan Abdullah - Universiti Teknologi MARA ( Site 0029)
Bandar Puncak Alam, Selangor, 42300
Hospital Pakar Kanak - Kanak UKM (HPKK) ( Site 0024)
Cheras, Kuala Lumpur, 56000
Hospital Tunku Azizah-Paediatric ( Site 0022)
Kuala Lumpur, 50300
University Malaya Medical Centre-Department of Paediatrics ( Site 0025)
Lembah Pantai, Kuala Lumpur, 59100
Sunway Medical Centre ( Site 0027)
Petaling Jaya, Selangor, 47500
Hospital Sibu ( Site 0021)
Sibu, Sarawak, 96000
Philippines6 sites
Health Index Multispecialty And Lying-In Clinic ( Site 0042)
Bacoor, Cavite, 4102
Chong Hua Hospital ( Site 0051)
Cebu City, Cebu, 6000
Norzel Medical and Diagnostic Clinic Foundation Corp ( Site 0044)
Cebu City, Central Visayas (Region VII), 6000
West Visayas State University Medical Center ( Site 0045)
Iloilo City, Iloilo, 5000
Philippine General Hospital ( Site 0041)
Manila, National Capital Region, 1000
University of the Philippines Manila ( Site 0047)
Metro Manila, National Capital Region, 1000
Indonesia5 sites
Jatinegara Primary Health Center ( Site 0102)
East Jakarta, Jakarta Special Capital Region, 13310
Cipayung Primary Health Center ( Site 0105)
East Jakarta, Jakarta Special Capital Region, 13840
Dr Cipto Mangunkusumo Hospital-Pediatrics ( Site 0101)
Jakarta, Jakarta Special Capital Region, 10430
Kelapa Gading Primary Health Center ( Site 0104)
North Jakarta, Jakarta Special Capital Region, 14240
Pasar Minggu Primary Health Center ( Site 0103)
South Jakarta, Jakarta Special Capital Region, 12620
Puerto Rico5 sites
Clinical Research Investigator Group ( Site 0110)
Bayamón, 00960
San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0114)
Caguas, 00726
Ponce Medical School Foundation Inc./CAIMED Center ( Site 0112)
Ponce, 00716
Latin Clinical Trial Center ( Site 0113)
San Juan, 00909
Wellness clinical Research Vega Baja ( Site 0116)
Vega Baja, 00693
Vietnam5 sites
Cai Lay Regional General Hospital ( Site 0093)
Cai Lậy, Tien Giang, 860 000
Quang Nam Hospital for Women and Children ( Site 0094)
Da Nang, 550000
Dong Thap General Hospital ( Site 0092)
Dong Thập, 810000
Pasteur Institute in Ho Chi Minh city ( Site 0089)
Ho Chi Minh City, 70000
Kien Giang Women's and Children hospital ( Site 0091)
Rach Gia, An Giang, 920 000
Singapore3 sites
National University Hospital-Paediatrics ( Site 0001)
Singapore, Central Singapore, 119074
KK Women's and Children's Hospital ( Site 0002)
Singapore, Central Singapore, 229899
Tan Tock Seng Hospital ( Site 0003)
Singapore, Central Singapore, 308433
About this study
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
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.
Read the detailed 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.
- Conditions
- Healthy
- Being tested
- V181, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V181Biological
Participants will receive a single 0.5 mL SC dose of V181 on Day 1.
PlaceboBiological
Participants will receive a single 0.5 mL SC dose of placebo on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| V181 | Experimental | Participants will receive a single 0.5 mL subcutaneous (SC) dose of V181 on Day 1. Receives: Biological: V181 |
| Placebo | Placebo comparator | Participants will receive a single 0.5 mL SC dose of placebo on Day 1. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
Measured: 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
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
Measured: 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
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
Measured: 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
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
Measured: 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
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. Clinical evaluation for presence of dengue with warning signs or severe dengue will be conducted by an investigator or medically qualified designee, based on pre-specified criteria.
Measured: Up to approximately 3 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, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. Clinical evaluation for presence of dengue with warning signs or severe dengue will be conducted by an investigator or medically qualified designee, based on pre-specified criteria.
Measured: Up to approximately 3 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 5 Years Postvaccination
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. Clinical evaluation for presence of dengue with warning signs or severe dengue will be conducted by an investigator or medically qualified designee, based on pre-specified criteria.
Measured: 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, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. Clinical evaluation for presence of dengue with warning signs or severe dengue will be conducted by an investigator or medically qualified designee, based on pre-specified criteria.
Measured: Up to approximately 5 years postvaccination
Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
Measured: Up to approximately 3 years postvaccination
Percentage of Participants Experiencing Hospitalization Resulting from 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
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
Measured: Up to approximately 3 years postvaccination
Percentage of Participants Experiencing Hospitalization Resulting from 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
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
Measured: Up to approximately 5 years postvaccination
Percentage of Participants Experiencing Hospitalization Resulting from 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
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
Measured: Up to approximately 5 years postvaccination
Percentage of Participants Experiencing Symptomatic (Regardless of Fever) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
Measured: Up to approximately 3 years postvaccination
Percentage of Participants Experiencing Symptomatic (Regardless of Fever) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
Measured: Up to approximately 3 years postvaccination
Percentage of Participants Experiencing Symptomatic (Regardless of Fever) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
Measured: Up to approximately 5 years postvaccination
Percentage of Participants Experiencing Symptomatic (Regardless of Fever) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
Measured: Up to approximately 5 years postvaccination
Percentage of Participants Experiencing Symptomatic (Regardless of Fever) VCD Meeting Criteria for Warning Signs or Severe Dengue, Regardless of Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. Clinical evaluation for presence of dengue with warning signs or severe dengue will be conducted by an investigator or medically qualified designee, based on pre-specified criteria.
Measured: Up to approximately 3 years postvaccination
Percentage of Participants Experiencing Symptomatic (Regardless of Fever) VCD Meeting Criteria for Warning Signs or Severe Dengue, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. Clinical evaluation for presence of dengue with warning signs or severe dengue will be conducted by an investigator or medically qualified designee, based on pre-specified criteria.
Measured: Up to approximately 3 years postvaccination
Percentage of Participants Experiencing Symptomatic (Regardless of Fever) VCD Meeting Criteria for Warning Signs or Severe Dengue, Regardless of Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. Clinical evaluation for presence of dengue with warning signs or severe dengue will be conducted by an investigator or medically qualified designee, based on pre-specified criteria.
Measured: Up to approximately 5 years postvaccination
Percentage of Participants Experiencing Symptomatic (Regardless of Fever) VCD Meeting Criteria for Warning Signs or Severe Dengue, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. Clinical evaluation for presence of dengue with warning signs or severe dengue will be conducted by an investigator or medically qualified designee, based on pre-specified criteria.
Measured: Up to approximately 5 years postvaccination
Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Regardless of Fever) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
Measured: Up to approximately 3 years postvaccination
Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Regardless of Fever) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
Measured: Up to approximately 3 years postvaccination
Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Regardless of Fever) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
Measured: Up to approximately 5 years postvaccination
Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Regardless of Fever) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
Measured: Up to approximately 5 years postvaccination
Reactogenicity and Immunogenicity Subset: Percentage of Participants who are Seropositive as measured by VRNT, by Dengue Serostatus at Baseline
Seropositivity for Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported.
Measured: Up to approximately 28 days postvaccination
Reactogenicity and Immunogenicity Subset: Percentage of Participants who are Seropositive as measured by VRNT, Regardless of Dengue Serostatus at Baseline
Seropositivity for Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported.
Measured: Up to approximately 28 days postvaccination
Reactogenicity and Immunogenicity Subset: Percentage of Participants who Seroconvert as measured by VRNT, by Dengue Serostatus at Baseline
Seroconversion rate for Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported.
Measured: Up to approximately 28 days postvaccination
Reactogenicity and Immunogenicity Subset: Percentage of Participants who Seroconvert as measured by VRNT, Regardless of Dengue Serostatus at Baseline
Seroconversion rate for Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported.
Measured: Up to approximately 28 days postvaccination
Reactogenicity and Immunogenicity Subset: Dengue Virus-Neutralizing Antibody Titers, as Measured by VRNT, by Dengue Serostatus at Baseline
Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported.
Measured: Up to approximately 28 days postvaccination
Reactogenicity and Immunogenicity Subset: Dengue Virus-Neutralizing Antibody Titers, as Measured by VRNT, Regardless of Dengue Serostatus at Baseline
Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported.
Measured: Up to approximately 28 days postvaccination
Reactogenicity and Immunogenicity Subset: Geometric Mean Fold Rises (GMFRs) in Dengue Virus-Neutralizing Antibody Titers, by Dengue Serostatus at Baseline
GMFRs for Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported.
Measured: Baseline (Day 1) and up to approximately 28 days postvaccination
Reactogenicity and Immunogenicity Subset: GMFRs in Dengue Virus-Neutralizing Antibody Titers, Regardless of Dengue Serostatus at Baseline
GMFRs for Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported.
Measured: Baseline (Day 1) and up to approximately 28 days postvaccination
Long-term Immunogenicity Subset: Percentage of Participants who are Seropositive, as measured by VRNT, by Dengue Serostatus at Baseline
Seropositivity for Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported.
Measured: Up to approximately 5 years postvaccination
Long-term Immunogenicity Subset: Percentage of Participants who are Seropositive, as measured by VRNT, Regardless of Dengue Serostatus at Baseline
Seropositivity for Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported.
Measured: Up to approximately 5 years postvaccination
Long-term Immunogenicity Subset: Percentage of Participants who Seroconvert, as measured by VRNT, by Dengue Serostatus at Baseline
Seroconversion rate for Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported.
Measured: Up to approximately 5 years postvaccination
Long-term Immunogenicity Subset: Percentage of Participants who Seroconvert as measured by VRNT, Regardless of Dengue Serostatus at Baseline
Seroconversion rate for Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported.
Measured: Up to approximately 5 years postvaccination
Long-term Immunogenicity Subset: Dengue Virus-Neutralizing Antibody Titers, as Measured by VRNT, by Dengue Serostatus at Baseline
Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported.
Measured: Up to approximately 5 years postvaccination
Long-term Immunogenicity Subset: Dengue Virus-Neutralizing Antibody Titers, as Measured by VRNT, Regardless of Dengue Serostatus at Baseline
Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported.
Measured: Up to approximately 5 years postvaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start11 Jun 2025
- Primary completion24 Oct 2031 (estimated)
- Study completion24 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013487
- Sponsor's protocol ID
- V181-005
- Other IDs
- MOBILIZE-1, 2022-003483-25
- Status last verified
- Oct 2026
- First submitted
- 2 Jun 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07013487
- Acronym / sponsor ID
- V181-005
- Conditions
- Healthy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 24 Oct 2031 (estimated)
- Study completion
- 24 Oct 2031 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V181 | Experimental | Biological: V181Participants will receive a single 0.5 mL subcutaneous (SC) dose of V181 on Day 1. |
| Placebo | Placebo comparator | Biological: PlaceboParticipants will receive a single 0.5 mL SC dose of placebo on Day 1. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V181Participants will receive a single 0.5 mL SC dose of V181 on Day 1. | Biological | V181 |
| PlaceboParticipants will receive a single 0.5 mL SC dose of placebo on Day 1. | Biological | Placebo |
Primary outcome
Percentage of Participants Experiencing a Medically Attended Adverse Event (MAAE)
Time frame: Up to approximately 6 months postvaccination
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.
Percentage of Participants Experiencing a Serious Adverse Event (SAE)
Time frame: Up to approximately 5 years postvaccination
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.
Reactogenicity and Immunogenicity Subset: Percentage of Participants Experiencing Solicited Injection-site AEs
Time frame: Up to approximately 5 days postvaccination
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.
Reactogenicity and Immunogenicity Subset: Percentage of Participants Experiencing Solicited Systemic AEs
Time frame: Up to approximately 28 days postvaccination
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).
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
Time frame: Up to approximately 3 years postvaccination
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).
38 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to approximately 3 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, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
Time frame: Up to approximately 3 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 5 Years Postvaccination
Time frame: 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, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
Time frame: Up to approximately 5 years postvaccination
Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
Time frame: Up to approximately 3 years postvaccination
Percentage of Participants Experiencing Hospitalization Resulting from 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
Time frame: Up to approximately 3 years postvaccination
Percentage of Participants Experiencing Hospitalization Resulting from 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
Time frame: Up to approximately 5 years postvaccination
Percentage of Participants Experiencing Hospitalization Resulting from 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
Time frame: Up to approximately 5 years postvaccination
Percentage of Participants Experiencing Symptomatic (Regardless of Fever) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
Time frame: Up to approximately 3 years postvaccination
Percentage of Participants Experiencing Symptomatic (Regardless of Fever) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
Time frame: Up to approximately 3 years postvaccination
Percentage of Participants Experiencing Symptomatic (Regardless of Fever) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
Time frame: Up to approximately 5 years postvaccination
Percentage of Participants Experiencing Symptomatic (Regardless of Fever) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
Time frame: Up to approximately 5 years postvaccination
Percentage of Participants Experiencing Symptomatic (Regardless of Fever) VCD Meeting Criteria for Warning Signs or Severe Dengue, Regardless of Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
Time frame: Up to approximately 3 years postvaccination
Percentage of Participants Experiencing Symptomatic (Regardless of Fever) VCD Meeting Criteria for Warning Signs or Severe Dengue, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
Time frame: Up to approximately 3 years postvaccination
Percentage of Participants Experiencing Symptomatic (Regardless of Fever) VCD Meeting Criteria for Warning Signs or Severe Dengue, Regardless of Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
Time frame: Up to approximately 5 years postvaccination
Percentage of Participants Experiencing Symptomatic (Regardless of Fever) VCD Meeting Criteria for Warning Signs or Severe Dengue, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
Time frame: Up to approximately 5 years postvaccination
Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Regardless of Fever) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
Time frame: Up to approximately 3 years postvaccination
Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Regardless of Fever) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
Time frame: Up to approximately 3 years postvaccination
Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Regardless of Fever) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
Time frame: Up to approximately 5 years postvaccination
Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Regardless of Fever) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
Time frame: Up to approximately 5 years postvaccination
Reactogenicity and Immunogenicity Subset: Percentage of Participants who are Seropositive as measured by VRNT, by Dengue Serostatus at Baseline
Time frame: Up to approximately 28 days postvaccination
Reactogenicity and Immunogenicity Subset: Percentage of Participants who are Seropositive as measured by VRNT, Regardless of Dengue Serostatus at Baseline
Time frame: Up to approximately 28 days postvaccination
Reactogenicity and Immunogenicity Subset: Percentage of Participants who Seroconvert as measured by VRNT, by Dengue Serostatus at Baseline
Time frame: Up to approximately 28 days postvaccination
Reactogenicity and Immunogenicity Subset: Percentage of Participants who Seroconvert as measured by VRNT, Regardless of Dengue Serostatus at Baseline
Time frame: Up to approximately 28 days postvaccination
Reactogenicity and Immunogenicity Subset: Dengue Virus-Neutralizing Antibody Titers, as Measured by VRNT, by Dengue Serostatus at Baseline
Time frame: Up to approximately 28 days postvaccination
Reactogenicity and Immunogenicity Subset: Dengue Virus-Neutralizing Antibody Titers, as Measured by VRNT, Regardless of Dengue Serostatus at Baseline
Time frame: Up to approximately 28 days postvaccination
Reactogenicity and Immunogenicity Subset: Geometric Mean Fold Rises (GMFRs) in Dengue Virus-Neutralizing Antibody Titers, by Dengue Serostatus at Baseline
Time frame: Baseline (Day 1) and up to approximately 28 days postvaccination
Reactogenicity and Immunogenicity Subset: GMFRs in Dengue Virus-Neutralizing Antibody Titers, Regardless of Dengue Serostatus at Baseline
Time frame: Baseline (Day 1) and up to approximately 28 days postvaccination
Long-term Immunogenicity Subset: Percentage of Participants who are Seropositive, as measured by VRNT, by Dengue Serostatus at Baseline
Time frame: Up to approximately 5 years postvaccination
Long-term Immunogenicity Subset: Percentage of Participants who are Seropositive, as measured by VRNT, Regardless of Dengue Serostatus at Baseline
Time frame: Up to approximately 5 years postvaccination
Long-term Immunogenicity Subset: Percentage of Participants who Seroconvert, as measured by VRNT, by Dengue Serostatus at Baseline
Time frame: Up to approximately 5 years postvaccination
Long-term Immunogenicity Subset: Percentage of Participants who Seroconvert as measured by VRNT, Regardless of Dengue Serostatus at Baseline
Time frame: Up to approximately 5 years postvaccination
Long-term Immunogenicity Subset: Dengue Virus-Neutralizing Antibody Titers, as Measured by VRNT, by Dengue Serostatus at Baseline
Time frame: Up to approximately 5 years postvaccination
Long-term Immunogenicity Subset: Dengue Virus-Neutralizing Antibody Titers, as Measured by VRNT, Regardless of Dengue Serostatus at Baseline
Time frame: Up to approximately 5 years postvaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
41 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing V181 in people with Healthy, run by Merck Sharp & Dohme LLC at 41 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Thailand, Malaysia, Philippines, Indonesia, Puerto Rico and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Experiencing a Medically Attended Adverse Event (MAAE) (time frame: Up to approximately 6 months postvaccination). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.