Approval Probability
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V181 · 2 trials · 2 indications
A MAAE is an adverse event (AE) in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an ER visit, office visit, or an urgent care visit with any medical personnel for any reason.
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.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. Solicited injection-site AEs will include pain/tenderness, erythema/redness, and swelling.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. Solicited systemic AEs will include rash, headache, tiredness (fatigue), muscle aches all over body (myalgia), joint pain and fever (pyrexia).
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by wild type (WT) reverse transcription polymerase chain reaction (RT-PCR) or non-structural protein 1 (NS1) enzyme-linked immunosorbent assay (ELISA).
A dengue VRNT was conducted to assess neutralizing antibody geometric mean titers (GMTs) for each of the 4 dengue serotypes (DENV1, DENV2, DENV3, and DENV4) in specimens collected from participants on Day 28 post-vaccination
A dengue VRNT was conducted to assess the percentage of participants who seroconverted for each of the 4 dengue serotypes (DENV-1, DENV-2, DENV-3 and DENV-4) at Day 28 post-vaccination. Seroconversion was defined as achieving a serotype-specific VRNT titer ≥lower limit of quantification (LLOQ) at Day 28 post-vaccination in the analysis population.
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 was determined by the investigator.
| Arm | Type | Description |
|---|---|---|
| V181 | EXPERIMENTAL | Participants will receive a single 0.5 mL subcutaneous (SC) dose of V181 on Day 1. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single 0.5 mL SC dose of placebo on Day 1. |
| Butantan - DV | EXPERIMENTAL | Participants received a single 0.5 mL SC injection of Butantan - DV. |
| Name | Type | Description |
|---|---|---|
| V181 | BIOLOGICAL | Participants will receive a single 0.5 mL SC dose of V181 on Day 1. |
| Placebo | BIOLOGICAL | Participants will receive a single 0.5 mL SC dose of placebo on Day 1. |
| Butantan - DV | BIOLOGICAL | 0.5 mL SC dose of Butantan - DV |
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 acquire...
Top 2 of 5 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 5 | PHASE3 | Qdenga |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | EYU688 |
V181 is an investigational dengue vaccine being developed by Merck & Company, Inc. (ticker MRK). It is a monoclonal antibody-based product in Phase 3 development for the prevention of dengue. Merck is evaluating it in healthy participants, including children and adults, across multiple countries in Asia, Latin America, and the Caribbean.
V181 is being developed for the prevention of dengue, an infectious disease. It is intended for use in healthy participants, with clinical studies enrolling children as young as 2 years old as well as adults. It is investigational and has not been approved for any indication.
V181 is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is running the clinical development program, including a Phase 3 study in healthy children and a completed Phase 2 bridging study in healthy adults in Brazil.
V181 is in Phase 3 clinical development. The Phase 3 trial is active but not recruiting, and a Phase 2 bridging study has been completed. V181 is investigational and has not been approved by the FDA or any other regulatory agency for the prevention of dengue.
V181 has been studied in two clinical trials. The Phase 3 trial NCT07013487 (MOBILIZE-1) enrolled 12,000 healthy participants aged 2 to 17 years across Indonesia, Malaysia, the Philippines, Puerto Rico, Singapore, Thailand, and Vietnam. The completed Phase 2 bridging trial NCT05710224 enrolled 1,364 healthy adults aged 18 to 50 in Brazil.
No. V181 is Merck's dengue vaccine candidate, while the Butantan dengue vaccine (Butantan-DV) is a separate product developed by the Butantan Institute. A Phase 2 clinical bridging study, NCT05710224, compared V181 to the Butantan dengue vaccine in healthy adults in Brazil.