A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)
Healthy
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 3
- Age range
- 2 years - 17 years
- Sex eligible
- All sexes
- Healthy volunteers
- Accepted
- Participants
- 12000 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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 full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Double masked
V181
Participants will receive a single 0.5 mL subcutaneous (SC) dose of V181 on Day 1.
Biological: V181
Placebo
Participants will receive a single 0.5 mL SC dose of placebo on Day 1.
Biological: Placebo
V181 BIOLOGICAL
Participants will receive a single 0.5 mL SC dose of V181 on Day 1.
Placebo BIOLOGICAL
Participants will receive a single 0.5 mL SC dose of placebo on Day 1.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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).
Secondary measures
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
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
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
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
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
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
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
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
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
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.
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
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.
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
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.
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
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.
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
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
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
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
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
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
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
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
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
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
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
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
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
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
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
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
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
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.
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
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.
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
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.
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
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.
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
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
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
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
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
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
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
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
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
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.
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
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.
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
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.
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
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.
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
Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported.
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
Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported.
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
Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (41)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
41 locations
Jatinegara Primary Health Center ( Site 0102)East Jakarta, Jakarta Special Capital Region, IndonesiaStatus unknown
Cipayung Primary Health Center ( Site 0105)East Jakarta, Jakarta Special Capital Region, IndonesiaStatus unknown
Dr Cipto Mangunkusumo Hospital-Pediatrics ( Site 0101)Jakarta, Jakarta Special Capital Region, IndonesiaStatus unknown
Kelapa Gading Primary Health Center ( Site 0104)North Jakarta, Jakarta Special Capital Region, IndonesiaStatus unknown
Pasar Minggu Primary Health Center ( Site 0103)South Jakarta, Jakarta Special Capital Region, IndonesiaStatus unknown
Hospital Pakar Kanak - Kanak UKM (HPKK) ( Site 0024)Cheras, Kuala Lumpur, MalaysiaStatus unknown
University Malaya Medical Centre-Department of Paediatrics ( Site 0025)Lembah Pantai, Kuala Lumpur, MalaysiaStatus unknown
Hospital Sibu ( Site 0021)Sibu, Sarawak, MalaysiaStatus unknown
Hospital Ampang ( Site 0028)Ampang, Selangor, MalaysiaStatus unknown
Hospital Al-Sultan Abdullah - Universiti Teknologi MARA ( Site 0029)Bandar Puncak Alam, Selangor, MalaysiaStatus unknown
Sunway Medical Centre ( Site 0027)Petaling Jaya, Selangor, MalaysiaStatus unknown
Hospital Tunku Azizah-Paediatric ( Site 0022)Kuala Lumpur, MalaysiaStatus unknown
Health Index Multispecialty And Lying-In Clinic ( Site 0042)Bacoor, Cavite, PhilippinesStatus unknown
Chong Hua Hospital ( Site 0051)Cebu City, Cebu, PhilippinesStatus unknown
Norzel Medical and Diagnostic Clinic Foundation Corp ( Site 0044)Cebu City, Central Visayas (Region VII), PhilippinesStatus unknown
West Visayas State University Medical Center ( Site 0045)Iloilo City, Iloilo, PhilippinesStatus unknown
Philippine General Hospital ( Site 0041)Manila, National Capital Region, PhilippinesStatus unknown
University of the Philippines Manila ( Site 0047)Metro Manila, National Capital Region, PhilippinesStatus unknown
Clinical Research Investigator Group ( Site 0110)Bayamón, Puerto RicoStatus unknown
San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0114)Caguas, Puerto RicoStatus unknown
Ponce Medical School Foundation Inc./CAIMED Center ( Site 0112)Ponce, Puerto RicoStatus unknown
Latin Clinical Trial Center ( Site 0113)San Juan, Puerto RicoStatus unknown
Wellness clinical Research Vega Baja ( Site 0116)Vega Baja, Puerto RicoStatus unknown
National University Hospital-Paediatrics ( Site 0001)Singapore, Central Singapore, SingaporeStatus unknown
KK Women's and Children's Hospital ( Site 0002)Singapore, Central Singapore, SingaporeStatus unknown
Tan Tock Seng Hospital ( Site 0003)Singapore, Central Singapore, SingaporeStatus unknown
Chulalongkorn University-Pediatrics ( Site 0063)Bangkok, Bangkok, ThailandStatus unknown
Faculty of Tropical Medicine, Mahidol University ( Site 0062)Bangkok, Bangkok, ThailandStatus unknown
Queen Sirikit National Institute of Child Health-Pediatric Infectious Disease ( Site 0071)Bangkok, Bangkok, ThailandStatus unknown
Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0065)Bangkok, Bangkok, ThailandStatus unknown
Faculty of Tropical Medicine, Mahidol University - Vaccine Trial Centre ( Site 0067)Ratchathewi, Bangkok, ThailandStatus unknown
Kamphaeng Phet-AFRIMS Virology Research Unit KAVRU ( Site 0070)Muang, Changwat Kamphaeng Phet, ThailandStatus unknown
Faculty of Medicine - Khon Kaen University-Pediatrics ( Site 0064)Amphoe Mueang, Changwat Khon Kaen, ThailandStatus unknown
Thammasat University Hospital-Department of Pediatrics ( Site 0068)Khong Luang, Changwat Pathum Thani, ThailandStatus unknown
Songklanagarind hospital-Department of Pediatrics ( Site 0061)Hat Yai, Changwat Songkhla, ThailandStatus unknown
Maharaj Nakorn Chiang Mai Hospital ( Site 0066)Muang, Chiang Mai, ThailandStatus unknown
Kien Giang Women's and Children hospital ( Site 0091)Rach Gia, An Giang, VietnamStatus unknown
Cai Lay Regional General Hospital ( Site 0093)Cai Lậy, Tien Giang, VietnamStatus unknown
Quang Nam Hospital for Women and Children ( Site 0094)Da Nang, VietnamStatus unknown
Dong Thap General Hospital ( Site 0092)Dong Thập, VietnamStatus unknown
Pasteur Institute in Ho Chi Minh city ( Site 0089)Ho Chi Minh City, VietnamStatus unknown
Study team and timeline
- Lead sponsor
- Merck Sharp & Dohme LLC
- Study start
- Jun 11, 2025 Actual
- Primary completion
- Sep 6, 2031 Estimated
- Study completion
- Sep 6, 2031 Estimated
- First posted
- Jun 10, 2025 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study 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
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026