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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 3

Conditions: Healthy

Treatments: Biological: Placebo; Biological: V181

Study type: Interventional

Funder types: Industry

Identifiers

NCT07013487

V181-005

2022-003483-25 (EudraCT Number)

MOBILIZE-1 (Other Identifier)

Details and patient eligibility

About

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.

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.

Enrollment: 12,000 estimated patients

Sex: All

Ages: 2 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12,000 participants in 2 patient groups, including a placebo group

V181

Experimental group

Description:

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

Treatment:

Biological: V181

Placebo

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo