A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)
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
Merck Sharp & Dohme LLC
12,000 participants
Jun 11, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria1
- Is generally healthy based on medical history and physical examination.
Exclusion Criteria11
- 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.
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Interventions
Participants will receive a single 0.5 mL SC dose of V181 on Day 1.
Participants will receive a single 0.5 mL SC dose of placebo on Day 1.
Locations(37)
View Full Details on ClinicalTrials.gov
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NCT07013487