BridgeMD
New treatment option for Healthy
Official title A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)
ClinicalTrials.gov ID: NCT07013487
What this study is testing
What is V181?
V181 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for healthy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17. Healthy volunteers may be eligible.
You may be able to join if
- The key include but are not limited to:
- Is generally healthy based on medical history and physical examination. The key
You likely can't join if
- 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.
See the full eligibility criteria
- The key include but are not limited to:
- Is generally healthy based on medical history and physical examination. The key
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- 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
- Cheras, Kuala Lumpur, Malaysia
- 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
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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; Cheras, Kuala Lumpur, Malaysia; Lembah Pantai, Kuala Lumpur, Malaysia and 29 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.