Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
V540D · 1 trial · 1 indication
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 intervention.
Solicited systemic AEs include headache, fatigue, nausea, dizziness, muscle aches, joint pain.
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 intervention.
An unsolicited AE is an event that is not predefined as a solicited AE or is predefined as a solicited AE but reported at any time outside the solicited time period.
SAEs include AEs that result in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect.
AEs in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Routine visits are not considered MAAEs. Examples of routine visits include physical examination, wellness visits, or vaccinations.
ECIs are defined as an overdose of Sponsor's product, drug-induced liver injury events, or potential immune-mediated diseases (pIMDs).
| Arm | Type | Description |
|---|---|---|
| V540D | EXPERIMENTAL | Participants will receive vaccinations with V540D. |
| GARDASIL®9 | ACTIVE_COMPARATOR | Participants will receive vaccinations with GARDASIL®9. |
| Name | Type | Description |
|---|---|---|
| V540D | BIOLOGICAL | Experimental vaccine and adjuvant administered via intramuscular (IM) injection |
| GARDASIL®9 | BIOLOGICAL | Suspension administered via IM injection |
Inclusion Criteria: The key inclusion criteria include but are not limited to the following: * Is in good health based on medical history, physical examination, vital sign (VS) measurements and electrocardiograms (ECGs) performed before randomization Exclusion Criteria: The key exclusion criteri...
V540D is an investigational monoclonal antibody being studied in healthy adults. It is currently in Phase 1 clinical development, with a trial evaluating its tolerability and immunogenicity. The drug is not approved for any condition and remains under investigation.
V540D is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting a Phase 1 clinical trial to evaluate the drug's tolerability and immunogenicity in healthy adults.
V540D is in Phase 1 clinical development. It is an investigational monoclonal antibody being studied in a single active trial that is not yet recruiting participants. The drug has not been approved by regulatory authorities and remains in early-stage testing.
V540D is being evaluated in one clinical trial, NCT06688058, titled 'A Trial to Evaluate Tolerability and Immunogenicity of V540D in Healthy Adults (V540D-004).' This Phase 1 study is active but not recruiting, with an enrollment of 72 participants in the United States.
V540D is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials, meaning it has not yet been evaluated for safety and efficacy in large patient populations. The drug remains in early-stage development and is not available for clinical use.