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

RecruitingPhase 3

Sponsor: Merck Sharp & Dohme LLC

Conditions: Healthy

Interventions: V181, Placebo

Countries: Indonesia, Malaysia, Philippines, Puerto Rico, Singapore, Thailand, Vietnam

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 overview

Sex: ALL

Age: 2 Years to 17 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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).
* 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.

Locations (36)

East Jakarta, Jakarta Special Capital Region, Indonesia
East Jakarta, Jakarta Special Capital Region, Indonesia
Jakarta, Jakarta Special Capital Region, Indonesia
North Jakarta, Jakarta Special Capital Region, Indonesia
South Jakarta, Jakarta Special Capital Region, Indonesia
Lembah Pantai, Kuala Lumpur, Malaysia
Sibu, Sarawak, Malaysia
Ampang, Selangor, Malaysia
Bandar Puncak Alam, Selangor, Malaysia
Petaling Jaya, Selangor, Malaysia
Kuala Lumpur, Malaysia
Bacoor, Cavite, Philippines
Cebu City, Cebu, Philippines
Cebu City, Central Visayas (Region VII), Philippines
Iloilo City, Iloilo, Philippines
Manila, National Capital Region, Philippines
Metro Manila, National Capital Region, Philippines
Bayamón, Puerto Rico
Caguas, Puerto Rico
Ponce, Puerto Rico
Vega Baja, Puerto Rico
Singapore, Central Singapore, Singapore
Singapore, Central Singapore, Singapore
Singapore, Central Singapore, Singapore
Bangkok, Bangkok, Thailand
Bangkok, Bangkok, Thailand
Bangkok, Bangkok, Thailand
Bangkok, Bangkok, Thailand
Ratchathewi, Bangkok, Thailand
Amphoe Mueang, Changwat Khon Kaen, Thailand
+ 6 more on CT.gov