Healthy
Conditions
Brief summary
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: * Is safe and if people tolerate it * Works as well as V503 to cause an immune response (the body's response to protect against infections and illnesses) to the shared HPV types.
Interventions
BIOLOGICALV540A-2
Suspension administered via intramuscular (IM) injection.
BIOLOGICALV540A-3
Suspension administered via intramuscular (IM) injection.
BIOLOGICALGARDASIL®9
Suspension administered via IM injection.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 26 Years
Healthy volunteers
Yes
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 intervention period and for at least 30 days after the last dose of study intervention
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience ≥1 Solicited Injection-site Adverse Event (AE) | Up to approximately 7 months | 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. |
| Number of Participants Who Experience ≥1 Solicited Pyrexia AE | Up to approximately 7 months | 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. |
| Number of Participants Who Experience ≥1 Vaccine-related Serious AE (SAE) | Up to approximately 7 months | 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. |
| Geometric Mean Titers (GMTs) to Each of the Shared Human Papillomavirus (HPV) Vaccine Types at Day 29 Postdose 3 | Up to approximately 7 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMTs of Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 1 | Up to 29 days | 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. |
| GMTs of Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 2 | Up to approximately 3 months | 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. |
| GMTs to Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 3 | Up to approximately 7 months | 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. |
| Percentage of Participants with Seroconversion to Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 1 | Up to approximately 2 months | 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. |
| Percentage of Participants with Seroconversion to Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 2 | Up to approximately 3 months | 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. |
| Percentage of Participants with Seroconversion to Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 3 | Up to approximately 7 months | 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. |
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed