Clinical trial NCT07013487: A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-06-10
Enrollment: 12000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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).
* 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.

Primary outcomes:
measure: Percentage of Participants Experiencing a Medically Attended Adverse Event (MAAE)
timeFrame: Up to approximately 6 months postvaccination
measure: Percentage of Participants Experiencing a Serious Adverse Event (SAE)
timeFrame: Up to approximately 1 year postvaccination
measure: Percentage of Participants Experiencing a Vaccine-Related SAE
timeFrame: Up to approximately 5 years postvaccination
measure: Reactogenicity and Immunogenicity Subset: Percentage of Participants Experiencing Solicited Injection-site AEs
timeFrame: Up to approximately 5 days postvaccination
measure: Reactogenicity and Immunogenicity Subset: Percentage of Participants Experiencing Solicited Systemic AEs
timeFrame: Up to approximately 28 days postvaccination
measure: 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
timeFrame: Up to approximately 3 years postvaccination
Secondary outcomes:
measure: 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
timeFrame: Up to approximately 3 years postvaccination
measure: 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
timeFrame: Up to approximately 3 years postvaccination
measure: 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
timeFrame: Up to approximately 5 years postvaccination
measure: 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
timeFrame: Up to approximately 5 years postvaccination
measure: 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
timeFrame: Up to approximately 3 years postvaccination
measure: 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
timeFrame: Up to approximately 3 years postvaccination
measure: 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
timeFrame: Up to approximately 5 years postvaccination
measure: 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
timeFrame: Up to approximately 5 years postvaccination
measure: 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
timeFrame: Up to approximately 3 years postvaccination
measure: 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
timeFrame: Up to approximately 3 years postvaccination
measure: 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
timeFrame: Up to approximately 5 years postvaccination
measure: 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
timeFrame: Up to approximately 5 years postvaccination
measure: Percentage of Participants Experiencing Symptomatic (Regardless of Fever Duration) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
timeFrame: Up to approximately 3 years postvaccination
measure: Percentage of Participants Experiencing Symptomatic (Regardless of Fever Duration) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
timeFrame: Up to approximately 3 years postvaccination
measure: Percentage of Participants Experiencing Symptomatic (Regardless of Fever Duration) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
timeFrame: Up to approximately 5 years postvaccination
measure: Percentage of Participants Experiencing Symptomatic (Regardless of Fever Duration) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
timeFrame: Up to approximately 5 years postvaccination
measure: Percentage of Participants Experiencing Symptomatic (Regardless of Fever Duration) VCD Meeting Criteria for Warning Signs or Severe Dengue, Regardless of Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
timeFrame: Up to approximately 3 years postvaccination
measure: Percentage of Participants Experiencing Symptomatic (Regardless of Fever Duration) VCD Meeting Criteria for Warning Signs or Severe Dengue, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
timeFrame: Up to approximately 3 years postvaccination
measure: Percentage of Participants Experiencing Symptomatic (Regardless of Fever Duration) VCD Meeting Criteria for Warning Signs or Severe Dengue, Regardless of Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
timeFrame: Up to approximately 5 years postvaccination
measure: Percentage of Participants Experiencing Symptomatic (Regardless of Fever Duration) VCD Meeting Criteria for Warning Signs or Severe Dengue, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
timeFrame: Up to approximately 5 years postvaccination
measure: Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Regardless of Fever Duration) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
timeFrame: Up to approximately 3 years postvaccination
measure: Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Regardless of Fever Duration) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
timeFrame: Up to approximately 3 years postvaccination
measure: Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Regardless of Fever Duration) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
timeFrame: Up to approximately 5 years postvaccination
measure: Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Regardless of Fever Duration) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
timeFrame: Up to approximately 5 years postvaccination
measure: Reactogenicity and Immunogenicity Subset: Percentage of Participants who are Seropositive as measured by VRNT, by Dengue Serostatus at Baseline
timeFrame: Up to approximately 28 days postvaccination
measure: Reactogenicity and Immunogenicity Subset: Percentage of Participants who are Seropositive as measured by VRNT, Regardless of Dengue Serostatus at Baseline
timeFrame: Up to approximately 28 days postvaccination
measure: Reactogenicity and Immunogenicity Subset: Percentage of Participants who Seroconvert as measured by VRNT, by Dengue Serostatus at Baseline
timeFrame: Up to approximately 28 days postvaccination
measure: Reactogenicity and Immunogenicity Subset: Percentage of Participants who Seroconvert as measured by VRNT, Regardless of Dengue Serostatus at Baseline
timeFrame: Up to approximately 28 days postvaccination
measure: Reactogenicity and Immunogenicity Subset: Dengue Virus-Neutralizing Antibody Titers, as Measured by VRNT, by Dengue Serostatus at Baseline
timeFrame: Up to approximately 28 days postvaccination
measure: Reactogenicity and Immunogenicity Subset: Dengue Virus-Neutralizing Antibody Titers, as Measured by VRNT, Regardless of Dengue Serostatus at Baseline
timeFrame: Up to approximately 28 days postvaccination
measure: Reactogenicity and Immunogenicity Subset: Geometric Mean Fold Rises (GMFRs) in Dengue Virus-Neutralizing Antibody Titers, by Dengue Serostatus at Baseline
timeFrame: Baseline (Day 1) and up to approximately 28 days postvaccination
measure: Reactogenicity and Immunogenicity Subset: GMFRs in Dengue Virus-Neutralizing Antibody Titers, Regardless of Dengue Serostatus at Baseline
timeFrame: Baseline (Day 1) and up to approximately 28 days postvaccination
measure: Long-term Immunogenicity Subset: Percentage of Participants who are Seropositive, as measured by VRNT, by Dengue Serostatus at Baseline
timeFrame: Up to approximately 5 years postvaccination
measure: Long-term Immunogenicity Subset: Percentage of Participants who are Seropositive, as measured by VRNT, Regardless of Dengue Serostatus at Baseline
timeFrame: Up to approximately 5 years postvaccination
measure: Long-term Immunogenicity Subset: Percentage of Participants who Seroconvert, as measured by VRNT, by Dengue Serostatus at Baseline
timeFrame: Up to approximately 5 years postvaccination
measure: Long-term Immunogenicity Subset: Percentage of Participants who Seroconvert as measured by VRNT, Regardless of Dengue Serostatus at Baseline
timeFrame: Up to approximately 5 years postvaccination
measure: Long-term Immunogenicity Subset: Dengue Virus-Neutralizing Antibody Titers, as Measured by VRNT, by Dengue Serostatus at Baseline
timeFrame: Up to approximately 5 years postvaccination
measure: Long-term Immunogenicity Subset: Dengue Virus-Neutralizing Antibody Titers, as Measured by VRNT, Regardless of Dengue Serostatus at Baseline
timeFrame: Up to approximately 5 years postvaccination
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital-Paediatrics ( Site 0001)
state: Central Singapore
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital ( Site 0003)
state: Central Singapore
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: