Efficacy, Immunogenicity, and Safety Study of V503 (9-valent Human Papillomavirus [9vHPV] Vaccine) in Japanese Males (V503-064)

Combined incidence of HPV type(s) 6/11/16/18-related anogenital persistent infection was defined to have occurred in a participant; 1) who is polymerase chain reaction (PCR) positive to at least one applicable HPV type(s) in 2 consecutive anogenital or biopsy samples from at least 2 consecutive visits 6 months (±1 month visit) or longer apart, or 2) who has a pathology diagnosis of condyloma, penile/perineal/perianal intraepithelial neoplasia, or penile, perineal or perianal cancer and PCR detection of at least one applicable HPV type(s) in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit with regardless of visit interval, prior to or following the biopsy showing HPV disease. Incidence was defined as the number of cases per 100 person-years of follow-up in both V503 and placebo arms. Per protocol, cases per 100 person-years is reported for applicable HPV type eligible participants with data available in the per-protocol efficacy population (PPE).

Time frame: Up to approximately 36 Months

Population: HPV type 6/11/16/18 eligible participants with data available in PPE population within acceptable day ranges; received all 3 vaccinations of correct dose within 1 year, Month 7 swab samples collected postdose 3 with PCR result, seronegative to the appropriate HPV type at baseline and PCR-negative to appropriate HPV type on all samples collected from baseline through Month 7, and no protocol deviations that could interfere with the evaluation of participant's immune response to the 9vHPV vaccine.

Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded using the vaccination report card (VRC). Per protocol, fever was defined as an oral temperature of ≥99.5°F(37.5°C). The number of participants who had at least 1 oral body temperature reading that was, \<99.5°F (\<37.5ºC), ≥99.5°F (≥37.5ºC) and \<100.4°F (38.0°C), or ≥100.4°F (38.0°C) and \<101.3°F(38.5°C), or ≥101.3°F(38.5°C) is reported here for all randomized participants in the APaT population with temperature data available.

Time frame: Up to 5 days after any vaccination

Population: All Participants as Treated (APaT) population with temperature data available. APaT consists of all randomized participants who received at least 1 dose of the V503 vaccine or placebo and have provided safety data at any time during the study.

An SAE 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, that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, results in persistent/significant disability/incapacity, is a congenital birth defect, or is another important medical event. The percentage of participants who experienced at least 1 SAE is reported here for all randomized participants in the All Participants as Treated (APaT) population.

Time frame: Up to approximately 37 months

Population: All Participants as Treated (APaT) population, which consists of all randomized participants who received at least 1 dose of the V503 vaccine or placebo and have provided safety data at any time during the study.

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. The percentage of participants who experienced at least 1 systemic AE is reported here for all randomized participants in the All Participants as Treated (APaT) population.

Time frame: Up to 15 days after any vaccination

Population: All Participants as Treated (APaT) population, which consists of all randomized participants who received at least 1 dose of the V503 vaccine or placebo and have provided safety data at any time during the study.

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. The participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 5 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, tenderness/pain, and swelling) is reported here for all randomized participants in the All Participants as Treated (APaT) population.

Time frame: Up to 5 days after any vaccination

Population: All Participants as Treated (APaT) population, all randomized participants who received at least 1 dose of the V503 vaccine or placebo and have provided safety data at any time during the study.

Combined incidence of HPV type(s) 31/33/45/52/58-related anogenital persistent infection was defined to have occurred in a participant; 1) who is polymerase chain reaction (PCR) positive to at least 1 applicable HPV type(s) in 2 consecutive anogenital or biopsy samples from at least 2 consecutive visits 6 months (±1 month visit) or longer apart, or 2) who has a pathology diagnosis of condyloma, penile/perineal/perianal intraepithelial neoplasia, or penile, perineal or perianal cancer and PCR detection of at least 1 applicable HPV type in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit with regardless of visit interval, prior to or following the biopsy showing HPV disease. Incidence was defined as the number of cases per 100 person-years of follow-up in both V503 and placebo arms. Per protocol, cases per 100 person-years is reported for applicable HPV type(s) eligible participants with data available in the per-protocol efficacy population (PPE).

Time frame: Up to approximately 36 Months

Population: HPV type 31/33/45/52/58 eligible participants with data available in PPE population within acceptable day ranges; received all 3 vaccinations of correct dose within 1 year, Month 7 swab samples collected postdose 3 with PCR result, seronegative to appropriate HPV type at baseline and PCR-negative to appropriate HPV type on all samples collected from baseline through Month 7, and no protocol deviations that could interfere with the evaluation of participant's immune response to the 9vHPV vaccine.

Antibodies to the HPV types 6/11/16/18/31/33/45/52/58 contained in V503 were measured using a competitive Luminex immunoassay (cLIA). Per protocol, antibody titers were expressed as milli Merck units/milliliter (mMU/mL). Geometric Mean Titers (GMTs) is reported for both V503 and Placebo for all randomized participants of the per-protocol immunogenicity population (PPI).

Time frame: Month 7

Population: Eligible all randomized participants PPI population; within acceptable day ranges; received 3 vaccinations of correct dose within 1 year, Month 7 swab samples collected postdose 3 with PCR result, seronegative to appropriate HPV type(s) at baseline and PCR-negative to appropriate HPV type(s) on samples collected from baseline through Month 7, provided serological samples, and had no protocol deviations that could interfere with the evaluation of participant's immune response to the V503 vaccine.

Antibodies to the HPV types 6/11/16/18/31/33/45/52/58 contained in V503 were measured using a competitive Luminex immunoassay (cLIA). Per protocol, antibody titers were expressed as milli Merck units/milliliter (mMU/mL). Geometric Mean Titers (GMTs) is reported for both V503 and Placebo for the heterosexual males (HM) subgroup of the per-protocol immunogenicity population (PPI).

Time frame: Month 7

Population: HM subgroup of the PPI population; within the acceptable day ranges, received 3 vaccinations of correct dose within 1 year, Month 7 swab samples collected postdose 3 with PCR result, seronegative to appropriate HPV type(s) at baseline and PCR-negative to appropriate HPV type(s) on all samples collected from baseline through Month 7, provided serological samples, and had no protocol deviations that could interfere with the evaluation of participant's immune response to the V503 vaccine.

Antibodies to the HPV types 6/11/16/18/31/33/45/52/58 contained in V503 were measured using a competitive Luminex immunoassay (cLIA). Per protocol, antibody titers were expressed as milli Merck units/milliliter (mMU/mL). Geometric Mean Titers (GMTs) is reported for both V503 and Placebo for the males who have sex with males (MSM) subgroup of the per-protocol immunogenicity population (PPI).

Time frame: Month 7

Population: MSM subgroup of the PPI population; within the acceptable day ranges, received 3 vaccinations of correct dose within 1 year, Month 7 swab samples collected postdose 3 with PCR result, seronegative to appropriate HPV type(s) at baseline and PCR-negative to appropriate HPV type(s) on all samples collected from baseline through Month 7, provided serological samples, and had no protocol deviations that could interfere with the evaluation of participant's immune response to the V503 vaccine.

Percentage of seroconversion to each of HPV 6/11/16/18/31/33/45/52/58 at Month 7 based on competitive Luminex immunoassay (cLIA) from participant serum samples. Seroconversion is defined as changing a participant's serostatus from seronegative at Day 1 to seropositive at 1 month post last dose Month 7. A participant with anti-HPV cLIA titer at or above the serostatus cutoff values of the cLIA for a given HPV type is considered seropositive for that HPV type. The serostatus cutoffs (milli Merck units/milliliter (mMU/mL)) for HPV types were as follows: HPV Type 6: ≥65, HPV Type 11: ≥37; HPV Type 16: ≥79, HPV Type 18: ≥85, HPV Type 31: ≥46, HPV Type 33: ≥26, HPV Type 45: ≥21, HPV Type 52: ≥30, and HPV Type 58: ≥31. The percentage of participants with seroconversion is reported for both V503 and Placebo for all randomized participants of the per-protocol immunogenicity population (PPI).

Time frame: Month 7

Population: Eligible all randomized participants PPI population; within acceptable day ranges; received 3 vaccinations of correct dose within 1 year, Month 7 swab samples collected postdose 3 with PCR result, seronegative to appropriate HPV type(s) at baseline and PCR-negative to appropriate HPV type(s) on samples collected from baseline through Month 7, provided serological samples, and had no protocol deviations that could interfere with the evaluation of participant's immune response to the V503 vaccine.

Percentage of seroconversion to each of HPV 6/11/16/18/31/33/45/52/58 at Month 7 based on competitive Luminex immunoassay (cLIA) from participant serum samples. Seroconversion is defined as changing a participant's serostatus from seronegative at Day 1 to seropositive at 1 month post last dose Month 7. A participant with anti-HPV cLIA titer at or above the serostatus cutoff values of the cLIA for a given HPV type is considered seropositive for that HPV type. The serostatus cutoffs (milli Merck units/milliliter (mMU/mL)) for HPV types were as follows: HPV Type 6: ≥65, HPV Type 11: ≥37; HPV Type 16: ≥79, HPV Type 18: ≥85, HPV Type 31: ≥46, HPV Type 33: ≥26, HPV Type 45: ≥21, HPV Type 52: ≥30, and HPV Type 58: ≥31. The percentage of participants with seroconversion is reported for both V503 and Placebo for the heterosexual males (HM) subgroup of the per-protocol immunogenicity population (PPI).

Time frame: Month 7

Population: HM subgroup of the PPI population; within the acceptable day ranges, received 3 vaccinations of correct dose within 1 year, Month 7 swab samples collected postdose 3 with PCR result, seronegative to appropriate HPV type(s) at baseline and PCR-negative to appropriate HPV type(s) on all samples collected from baseline through Month 7, provided serological samples, and had no protocol deviations that could interfere with the evaluation of participant's immune response to the V503 vaccine.

Percentage of seroconversion to each of HPV 6/11/16/18/31/33/45/52/58 at Month 7 based on competitive Luminex immunoassay (cLIA) from participant serum samples. Seroconversion is defined as changing a participant's serostatus from seronegative at Day 1 to seropositive at 1 month post last dose Month 7. A participant with anti-HPV cLIA titer at or above the serostatus cutoff values of the cLIA for a given HPV type is considered seropositive for that HPV type. The serostatus cutoffs (milli Merck units/milliliter (mMU/mL)) for HPV types were as follows: HPV Type 6: ≥65, HPV Type 11: ≥37; HPV Type 16: ≥79, HPV Type 18: ≥85, HPV Type 31: ≥46, HPV Type 33: ≥26, HPV Type 45: ≥21, HPV Type 52: ≥30, and HPV Type 58: ≥31. The percentage of participants with seroconversion is reported for both V503 and Placebo for the males who have sex with males (MSM) subgroup of the per-protocol immunogenicity population (PPI).

Time frame: Month 7

Population: MSM subgroup of the PPI population; within the acceptable day ranges, received 3 vaccinations of correct dose within 1 year, Month 7 swab samples collected postdose 3 with PCR result, seronegative to appropriate HPV type(s) at baseline and PCR-negative to appropriate HPV type(s) on all samples collected from baseline through Month 7, provided serological samples, and had no protocol deviations that could interfere with the evaluation of participant's immune response to the V503 vaccine.