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V540A-2 · 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 injection-site AEs include redness (erythema), swelling (swelling), and pain or tenderness (pain). The number of participants who experienced at least 1 solicited injection-site AE from Day 1 through Day 5 post each vaccination will be reported.
Pyrexia is defined as a temperature(s) ≥100.4°F (≥38.0°C). The number of participants with solicited pyrexia from Day 1 through Day 5 post each vaccination will be reported.
A vaccine-related SAE is any untoward medical consequence that results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event which is determined by the investigator to be related to the vaccine. The number of participants who experienced at least 1 vaccine-related SAE will be reported.
Antibodies to HPV types shared between V540A and GARDASIL®9 will be measured. Geometric mean titers of antibodies to HPV types at Day 29 postdose 3 will be reported.
| Arm | Type | Description |
|---|---|---|
| V540A-2 | EXPERIMENTAL | Participants will receive vaccinations of V540A-2. |
| V540A-3 | EXPERIMENTAL | Participants will receive vaccinations of V540A-3. |
| GARDASIL®9 | ACTIVE_COMPARATOR | Participants will receive vaccinations of V503. |
| Name | Type | Description |
|---|---|---|
| V540A-2 | BIOLOGICAL | Suspension administered via intramuscular (IM) injection. |
| V540A-3 | BIOLOGICAL | Suspension administered via intramuscular (IM) injection. |
| GARDASIL®9 | BIOLOGICAL | Suspension administered via IM injection. |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Is in good health * Has a lifetime history of 0 to 4 sexual partners of any sex/gender * A participant assigned female sex at birth is eligible to participate if not breastfeeding during the study inter...
V540A-2 is a monoclonal antibody being studied in healthy female participants. It is currently in Phase 2 clinical development as an investigational therapy. The drug is being evaluated in a clinical trial that enrolls healthy volunteers to assess its safety and effects.
V540A-2 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 research on this monoclonal antibody in healthy female participants.
V540A-2 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 study is designed to evaluate the drug in healthy female participants.
V540A-2 is being studied in a Phase 2 clinical trial with the identifier NCT07224477. This trial, titled "A Clinical Study of V540A in Healthy Female Participants (V540A-005)," is a randomized, double-blind, active-controlled study that plans to enroll 525 healthy female participants aged 16 years and older.
V540A-2 is a variant of the investigational monoclonal antibody V540A. The clinical trial NCT07224477 is titled "A Clinical Study of V540A in Healthy Female Participants," indicating that V540A-2 is related to the V540A program being developed by Merck & Company, Inc.