Approval Probability
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V181 High-Potency Level · 1 trial · 2 indications
A dengue VRNT was conducted to assess neutralizing antibody Geometric Mean Titers (GMTs) for each of the 4 dengue vaccine serotypes (DENV1, DENV2, DENV3, and DENV4) in specimens collected from participants on Day 28 post-vaccination.
An SAE is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine will be determined by the investigator.
| Arm | Type | Description |
|---|---|---|
| V181 High-Potency Level Group | EXPERIMENTAL | Participants will receive a single 0.5mL subcutaneous (SC) dose of V181 High-Potency vaccine. |
| V181 Mid-Potency Level Group | EXPERIMENTAL | Participants will receive a single 0.5mL SC dose of V181 Mid-Potency vaccine. |
| V181 Low-Potency Level Group | EXPERIMENTAL | Participants will receive a single 0.5mL SC dose of V181 Low-Potency vaccine. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single SC 0.5 mL dose of placebo. |
| Name | Type | Description |
|---|---|---|
| V181 High-Potency Level | BIOLOGICAL | 0.5 mL SC dose of V181 High-Potency vaccine |
| V181 Mid-Potency Level | BIOLOGICAL | 0.5 mL SC dose of V181 Mid-Potency vaccine |
| V181 Low-Potency Level | BIOLOGICAL | 0.5 mL SC dose of V181 Low-Potency vaccine |
| Placebo | BIOLOGICAL | 0.5 mL SC dose of placebo |
Inclusion Criteria: * Male participants are eligible to participate if they agree to the following for at least 90 days after administration of study intervention: Abstain from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree ...
V181 High-Potency Level is an investigational monoclonal antibody being developed for the prevention of Dengue Disease. It is currently in Phase 2 clinical development. The drug is being studied for its safety and immunogenicity in adults, as part of a placebo-controlled trial.
V181 High-Potency Level is a monoclonal antibody designed to target the dengue virus. As an antibody-based therapy, it is intended to provide protection against dengue infection. The specific molecular target is not disclosed in the available information.
V181 High-Potency Level is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and immunogenicity for dengue prevention.
V181 High-Potency Level is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in a completed Phase 2 trial that assessed its safety and immunogenicity in adults.
V181 High-Potency Level has one completed Phase 2 clinical trial registered under NCT05507450, titled 'Safety and Immunogenicity of Three V181 Dengue Vaccine Potencies in Adults (V181-003)'. This randomized, double-blind, placebo-controlled trial enrolled 1,271 participants across multiple countries.
V181 High-Potency Level is a specific potency formulation of the V181 dengue vaccine candidate. The clinical trial NCT05507450 evaluated three different potencies of V181, with the high-potency level being one of them. All are being developed by Merck & Company.