Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07224477 | A Clinical Study of V540A in Healthy Female Participants (V540A-005) | PHASE2 | NOT YET_RECRUITING | 525 | — | — | Jul 20, 2026 | Apr 4, 2028 | Feb 19, 2026 | - | — |
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...