Approval Probability
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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 developed by Merck & Company, Inc. (ticker MRK). It is in Phase 1 clinical development, with one active trial evaluating its tolerability and immunogenicity in healthy adult volunteers. The specific disease indications for V540D have not been disclosed.
V540D is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck is the sponsor of the ongoing Phase 1 trial for V540D.
V540D is in Phase 1 clinical development. One Phase 1 trial is currently active and recruiting has been completed, with the trial listed as active but not recruiting. No later-phase trials have been initiated.
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 trial is active but not recruiting, has enrolled 72 healthy adult participants in the United States, and is randomized, double-blind, and active-controlled.
V540D is not yet approved for any indication. It is an investigational monoclonal antibody in Phase 1 testing. The current trial is in healthy adult volunteers and is designed to assess tolerability and immunogenicity, not to treat a specific disease. The intended therapeutic indications have not been disclosed.