Approval Probability
TA Base Rate
Adjusted LOA
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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...
V181 is an investigational dengue vaccine being developed for the prevention of dengue disease. It is being studied in healthy adults and children, with clinical trials evaluating its use in participants aged 2 to 50 years. The vaccine is designed to provide protection against dengue virus infection.
V181 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical trials to evaluate the safety and efficacy of V181 as a dengue vaccine.
V181 is in clinical development, with trials in Phase 2 and Phase 3. A Phase 2 study has been completed, and a Phase 3 study is currently recruiting participants. The vaccine is investigational and has not been approved by regulatory authorities.
V181 is being evaluated in two clinical trials. NCT05710224 is a completed Phase 2 bridging study in healthy adults aged 18 to 50 in Brazil. NCT07013487 is a Phase 3 study in healthy participants aged 2 to 17, recruiting in multiple countries including Indonesia, Malaysia, and Thailand.
V181 is a dengue quadrivalent vaccine being compared to Butantan-DV in a clinical bridging study. The Phase 2 trial NCT05710224 evaluated V181 against Butantan-DV in healthy adults to assess similarity. V181 is a live, attenuated dengue vaccine developed by Merck.
V181 is a live, attenuated dengue quadrivalent vaccine. It contains weakened forms of the four dengue virus serotypes to stimulate an immune response without causing disease. This approach aims to generate protective immunity against all four dengue serotypes.