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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1314-2250 | Registry Identifier | UTN | |
| 2024-518805-16-00 | Registry Identifier | EU CT |
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Researchers are looking for new ways to prevent cancers related to human papillomavirus (HPV). HPV is a common virus that can cause an infection. There are many different types of HPV.
A standard vaccine to prevent HPV-related cancers is V503. V503 protects against 9 types of HPV. V540A is a study vaccine designed to protect against the same (shared) 9 HPV types plus other (unique) HPV types.
Researchers want to learn if V540A:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V540A-2 | Experimental | Participants will receive vaccinations of V540A-2. |
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| V540A-3 | Experimental | Participants will receive vaccinations of V540A-3. |
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| GARDASIL®9 | Active Comparator | Participants will receive vaccinations of V503. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V540A-2 | Biological | Suspension administered via intramuscular (IM) injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience ≥1 Solicited Injection-site Adverse Event (AE) | 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. | Up to approximately 7 months |
| Number of Participants Who Experience ≥1 Solicited Pyrexia AE | 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. | Up to approximately 7 months |
| Number of Participants Who Experience ≥1 Vaccine-related Serious AE (SAE) | 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. | Up to approximately 7 months |
| Geometric Mean Titers (GMTs) to Each of the Shared Human Papillomavirus (HPV) Vaccine Types at Day 29 Postdose 3 | 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. | Up to approximately 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| GMTs of Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 1 | Antibodies to HPV types shared between V540A and GARDASIL®9 and unique to V540A will be measured. Geometric mean titers of antibodies to HPV types at Day 29 postdose 1 will be reported. | Up to 29 days |
| GMTs of Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 2 |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary Link | View source |
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| ID | Term |
|---|---|
| C110128 | Neu1 protein, mouse |
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| V540A-3 |
| Biological |
Suspension administered via intramuscular (IM) injection. |
|
| GARDASIL®9 | Biological | Suspension administered via IM injection. |
|
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Antibodies to HPV types shared between V540A and GARDASIL®9 and unique to V540A will be measured. Geometric mean titers of antibodies to HPV types at Day 29 postdose 2 will be reported. |
| Up to approximately 3 months |
| GMTs to Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 3 | Antibodies to HPV types shared between V540A and GARDASIL®9 and unique to V540A will be measured. Geometric mean titers of antibodies to HPV types at Day 29 postdose 3 will be reported. | Up to approximately 7 months |
| Percentage of Participants with Seroconversion to Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 1 | Seroconversion is defined as changing a participant's serostatus from seronegative at Day 1 to seropositive by Day 29 postdose 1. The percentage of participants with seroconversion to each of the shared and unique HPV vaccine types at Day 29 postdose 1 will be reported. | Up to approximately 2 months |
| Percentage of Participants with Seroconversion to Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 2 | Seroconversion is defined as changing a participant's serostatus from seronegative at Day 1 to seropositive by Day 29 postdose 2. The percentage of participants with seroconversion to each of the shared and unique HPV vaccine types at Day 29 postdose 2 will be reported. | Up to approximately 3 months |
| Percentage of Participants with Seroconversion to Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 3 | Seroconversion is defined as changing a participant's serostatus from seronegative at Day 1 to seropositive by Day 29 postdose 3. The percentage of participants with seroconversion to each of the shared and unique HPV vaccine types at Day 29 postdose 3 will be reported. | Up to approximately 7 months |