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).

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.

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.

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.

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.

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).

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).

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).

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).

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).

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).

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).