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

Launched by MERCK SHARP & DOHME LLC · Jun 2, 2025

Keywords

ClinConnect Summary

This clinical trial, titled "A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age," aims to test a new dengue vaccine called V181. The goal is to see if this vaccine is safe, how well it works in helping the body fight off the dengue virus, and whether it can lower the chances of getting dengue, which is a disease spread by mosquitoes. The study will involve healthy children and teenagers aged 2 to 17 years.

To be eligible for the trial, participants should be generally healthy and not have any serious medical conditions, like severe infections or immune system problems. They should not have received any dengue vaccines before or plan to get one during the study. The trial is currently not recruiting participants, but once it starts, those who join can expect regular check-ups and monitoring to ensure their safety while testing this vaccine. This study is important as it may help protect children from dengue, which can cause serious illness.

Gender

ALL

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.