Trial Outcomes & Findings for Efficacy, Immunogenicity, and Safety Study of the 9vHPV Vaccine in Japanese Males (V503-064) (NCT NCT04635423)
NCT ID: NCT04635423
Last Updated: 2025-08-11
Results Overview
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).
COMPLETED
PHASE3
1059 participants
Up to approximately 36 Months
2025-08-11
Participant Flow
Participant milestones
| Measure |
V503
Participants receive an intramuscular (IM) injection of V503 (9-valent human papillomavirus \[9vHPV\] vaccine) at Day 1, Month 2, and Month 6.
|
Placebo
Participants receive an IM injection of placebo at Day 1, Month 2, and Month 6.
|
|---|---|---|
|
Overall Study
STARTED
|
529
|
530
|
|
Overall Study
Vaccination 1: Day 1
|
529
|
530
|
|
Overall Study
Vaccination 2: Month 2
|
523
|
518
|
|
Overall Study
Vaccination 3: Month 6
|
514
|
508
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
529
|
530
|
Reasons for withdrawal
| Measure |
V503
Participants receive an intramuscular (IM) injection of V503 (9-valent human papillomavirus \[9vHPV\] vaccine) at Day 1, Month 2, and Month 6.
|
Placebo
Participants receive an IM injection of placebo at Day 1, Month 2, and Month 6.
|
|---|---|---|
|
Overall Study
Ongoing
|
493
|
501
|
|
Overall Study
Withdrawal by Subject
|
36
|
29
|
Baseline Characteristics
Efficacy, Immunogenicity, and Safety Study of the 9vHPV Vaccine in Japanese Males (V503-064)
Baseline characteristics by cohort
| Measure |
V503
n=529 Participants
Participants receive an intramuscular (IM) injection of V503 (9-valent human papillomavirus \[9vHPV\] vaccine) at Day 1, Month 2, and Month 6.
|
Placebo
n=530 Participants
Participants receive an IM injection of placebo at Day 1, Month 2, and Month 6.
|
Total
n=1059 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.9 Years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
22.8 Years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
22.9 Years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
529 Participants
n=5 Participants
|
530 Participants
n=7 Participants
|
1059 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
529 Participants
n=5 Participants
|
530 Participants
n=7 Participants
|
1059 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
529 Participants
n=5 Participants
|
530 Participants
n=7 Participants
|
1059 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sexual Orientation Participant Subgroups
Heterosexual Males (HM)
|
473 Participants
n=5 Participants
|
474 Participants
n=7 Participants
|
947 Participants
n=5 Participants
|
|
Sexual Orientation Participant Subgroups
Males Who Have Sex With Males (MSM)
|
56 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 36 MonthsPopulation: 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.
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).
Outcome measures
| Measure |
V503
n=496 Participants
Participants receive an intramuscular (IM) injection of V503 (9-valent human papillomavirus \[9vHPV\] vaccine) at Day 1, Month 2, and Month 6.
|
Placebo
n=483 Participants
Participants receive an IM injection of placebo at Day 1, Month 2, and Month 6.
|
|---|---|---|
|
Combined Incidence of Human Papillomavirus (HPV) 6/11/16/18-related Anogenital Persistent Infection
|
0.2 Cases per 100 Person-years
|
2.2 Cases per 100 Person-years
|
PRIMARY outcome
Timeframe: Up to 5 days after any vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
V503
n=529 Participants
Participants receive an intramuscular (IM) injection of V503 (9-valent human papillomavirus \[9vHPV\] vaccine) at Day 1, Month 2, and Month 6.
|
Placebo
n=530 Participants
Participants receive an IM injection of placebo at Day 1, Month 2, and Month 6.
|
|---|---|---|
|
Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
|
69.8 Percentage of Participants
|
29.6 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 15 days after any vaccinationPopulation: 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.
Outcome measures
| Measure |
V503
n=529 Participants
Participants receive an intramuscular (IM) injection of V503 (9-valent human papillomavirus \[9vHPV\] vaccine) at Day 1, Month 2, and Month 6.
|
Placebo
n=530 Participants
Participants receive an IM injection of placebo at Day 1, Month 2, and Month 6.
|
|---|---|---|
|
Percentage of Participants With ≥1 Systemic AE
|
20.2 Percentage of Participants
|
19.8 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to approximately 37 monthsPopulation: 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 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.
Outcome measures
| Measure |
V503
n=529 Participants
Participants receive an intramuscular (IM) injection of V503 (9-valent human papillomavirus \[9vHPV\] vaccine) at Day 1, Month 2, and Month 6.
|
Placebo
n=530 Participants
Participants receive an IM injection of placebo at Day 1, Month 2, and Month 6.
|
|---|---|---|
|
Percentage of Participants With ≥1 Serious Adverse Events (SAEs)
|
1.3 Percentage of Participants
|
0.9 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 5 days after any vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
V503
n=527 Participants
Participants receive an intramuscular (IM) injection of V503 (9-valent human papillomavirus \[9vHPV\] vaccine) at Day 1, Month 2, and Month 6.
|
Placebo
n=526 Participants
Participants receive an IM injection of placebo at Day 1, Month 2, and Month 6.
|
|---|---|---|
|
Number of Participants With Elevated Oral Body Temperature
<99.5°F (37.5°C)
|
502 Participants
|
496 Participants
|
|
Number of Participants With Elevated Oral Body Temperature
≥99.5°F (≥37.5ºC) and <100.4°F (38.0°C)
|
19 Participants
|
22 Participants
|
|
Number of Participants With Elevated Oral Body Temperature
≥100.4°F (38.0°C) and <101.3°F(38.5°C)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Elevated Oral Body Temperature
≥101.3°F(38.5°C)
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 36 MonthsPopulation: 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.
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).
Outcome measures
| Measure |
V503
n=505 Participants
Participants receive an intramuscular (IM) injection of V503 (9-valent human papillomavirus \[9vHPV\] vaccine) at Day 1, Month 2, and Month 6.
|
Placebo
n=493 Participants
Participants receive an IM injection of placebo at Day 1, Month 2, and Month 6.
|
|---|---|---|
|
Combined Incidence of HPV 31/33/45/52/58-related Anogenital Persistent Infection
|
0.7 cases per 100 Person-years
|
1.9 cases per 100 Person-years
|
SECONDARY outcome
Timeframe: Month 7Population: 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 all randomized participants of the per-protocol immunogenicity population (PPI).
Outcome measures
| Measure |
V503
n=456 Participants
Participants receive an intramuscular (IM) injection of V503 (9-valent human papillomavirus \[9vHPV\] vaccine) at Day 1, Month 2, and Month 6.
|
Placebo
n=458 Participants
Participants receive an IM injection of placebo at Day 1, Month 2, and Month 6.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
Anti-HPV 6
|
927.3 mMU/mL
Interval 850.2 to 1011.3
|
21.1 mMU/mL
Interval to 22.5
NA: \< Lower Limit of Quantification (LLOQ) of 20 mMU/mL
|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
Anti-HPV 11
|
716.5 mMU/mL
Interval 654.4 to 784.5
|
NA mMU/mL
NA: \< LLOQ of 16 mMU/mL
|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
Anti-HPV 16
|
3491.6 mMU/mL
Interval 3196.5 to 3814.0
|
NA mMU/mL
NA: \< LLOQ of 20 mMU/mL
|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
Anti-HPV 18
|
998.0 mMU/mL
Interval 904.3 to 1101.4
|
45.5 mMU/mL
Interval 43.4 to 47.7
|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
HPV-31
|
832.1 mMU/mL
Interval 753.3 to 919.2
|
15.4 mMU/mL
Interval 14.3 to 16.5
|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
HPV-33
|
489.8 mMU/mL
Interval 448.6 to 534.7
|
12.7 mMU/mL
Interval 11.9 to 13.4
|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
Anti-HPV 45
|
326.6 mMU/mL
Interval 293.7 to 363.2
|
8.5 mMU/mL
Interval to 9.0
NA: \< LLOQ of 8 mMU/mL
|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
Anti-HPV 52
|
390.5 mMU/mL
Interval 356.3 to 428.0
|
10.1 mMU/mL
Interval 9.5 to 10.8
|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
Anti-HPV 58
|
588.3 mMU/mL
Interval 537.7 to 643.6
|
NA mMU/mL
NA: \< LLOQ of 8 mMU/mL
|
SECONDARY outcome
Timeframe: Month 7Population: 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 heterosexual males (HM) subgroup of the per-protocol immunogenicity population (PPI).
Outcome measures
| Measure |
V503
n=408 Participants
Participants receive an intramuscular (IM) injection of V503 (9-valent human papillomavirus \[9vHPV\] vaccine) at Day 1, Month 2, and Month 6.
|
Placebo
n=415 Participants
Participants receive an IM injection of placebo at Day 1, Month 2, and Month 6.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
Anti-HPV 6
|
950.2 mMU/mL
Interval 866.8 to 1041.6
|
21.0 mMU/mL
Interval to 22.6
NA: \< Lower Limit of Quantitation (LLOQ) of 20 mMU/mL
|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
Anti-HPV 11
|
730.6 mMU/mL
Interval 664.4 to 803.4
|
NA mMU/mL
NA: \< LLOQ of 16 mMU/mL
|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
Anti-HPV 16
|
3608.3 mMU/mL
Interval 3288.6 to 3959.0
|
NA mMU/mL
NA: \< LLOQ of 20 mMU/mL
|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
Anti-HPV 18
|
1044.7 mMU/mL
Interval 942.7 to 1157.7
|
45.1 mMU/mL
Interval 42.9 to 47.3
|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
Anti-HPV 31
|
867.8 mMU/mL
Interval 780.7 to 964.7
|
15.1 mMU/mL
Interval 14.0 to 16.3
|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
Anti-HPV 33
|
495.4 mMU/mL
Interval 451.9 to 543.1
|
12.6 mMU/mL
Interval 11.8 to 13.4
|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
Anti-HPV 45
|
333.8 mMU/mL
Interval 298.4 to 373.5
|
8.4 mMU/mL
Interval to 9.0
NA: \< LLOQ of 8 mMU/mL
|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
Ant-HPV 52
|
408.7 mMU/mL
Interval 372.1 to 448.9
|
10.0 mMU/mL
Interval 9.3 to 10.7
|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
Anti-HPV 58
|
609.1 mMU/mL
Interval 554.2 to 669.4
|
NA mMU/mL
NA: \< LLOQ of 8 mMU/mL
|
SECONDARY outcome
Timeframe: Month 7Population: 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.
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).
Outcome measures
| Measure |
V503
n=48 Participants
Participants receive an intramuscular (IM) injection of V503 (9-valent human papillomavirus \[9vHPV\] vaccine) at Day 1, Month 2, and Month 6.
|
Placebo
n=46 Participants
Participants receive an IM injection of placebo at Day 1, Month 2, and Month 6.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
Anti-HPV 6
|
740.2 mMU/mL
Interval 569.2 to 962.6
|
21.5 mMU/mL
Interval to 27.5
NA: \< Lower Limit of Quantification (LLOQ) of 20 mMU/mL
|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
Anti-HPV 11
|
598.8 mMU/mL
Interval 438.7 to 817.3
|
NA mMU/mL
NA: \< LLOQ of 16 mMU/mL
|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
Anti-HPV 16
|
2599.5 mMU/mL
Interval 1957.4 to 3452.4
|
NA mMU/mL
NA: \< LLOQ of 20 mMU/mL
|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
Anti-HPV 18
|
677.4 mMU/mL
Interval 487.6 to 941.0
|
49.7 mMU/mL
Interval 42.1 to 58.6
|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
Anti-HPV 31
|
593.2 mMU/mL
Interval 446.0 to 789.0
|
17.7 mMU/mL
Interval 14.1 to 22.2
|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
Anti-HPV 33
|
443.6 mMU/mL
Interval 327.9 to 600.1
|
13.5 mMU/mL
Interval 11.5 to 16.0
|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
Anti-HPV 45
|
266.6 mMU/mL
Interval 190.1 to 373.8
|
9.1 mMU/mL
Interval to 11.1
NA: \< LLOQ of 8 mMU/mL
|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
Anti-HPV 52
|
262.9 mMU/mL
Interval 186.7 to 370.2
|
11.3 mMU/mL
Interval 9.0 to 14.2
|
|
Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
Anti-HPV 58
|
437.7 mMU/mL
Interval 327.8 to 584.5
|
NA mMU/mL
Interval to 8.4
NA: \< LLOQ of 8 mMU/mL
|
SECONDARY outcome
Timeframe: Month 7Population: 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 all randomized participants of the per-protocol immunogenicity population (PPI).
Outcome measures
| Measure |
V503
n=456 Participants
Participants receive an intramuscular (IM) injection of V503 (9-valent human papillomavirus \[9vHPV\] vaccine) at Day 1, Month 2, and Month 6.
|
Placebo
n=458 Participants
Participants receive an IM injection of placebo at Day 1, Month 2, and Month 6.
|
|---|---|---|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
Anti-HPV 6 cLIA ≥65 mMU/mL
|
99.7 Percentage of Participants
Interval 98.6 to 100.0
|
3.5 Percentage of Participants
Interval 1.9 to 6.0
|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
Anti-HPV 11 cLIA ≥37 mMU/mL
|
99.7 Percentage of Participants
Interval 98.6 to 100.0
|
4.1 Percentage of Participants
Interval 2.3 to 6.7
|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
Anti-HPV 16 cLIA ≥79 mMU/mL
|
99.6 Percentage of Participants
Interval 98.4 to 99.9
|
4.3 Percentage of Participants
Interval 2.6 to 6.6
|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
Anti-HPV 18 cLIA ≥85 mMU/mL
|
99.3 Percentage of Participants
Interval 97.9 to 99.9
|
8.3 Percentage of Participants
Interval 5.8 to 11.4
|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
Anti-HPV 31 cLIA ≥46 mMU/mL
|
98.9 Percentage of Participants
Interval 97.3 to 99.6
|
5.6 Percentage of Participants
Interval 3.6 to 8.2
|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
Anti-HPV 33 cLIA ≥26 mMU/mL
|
99.8 Percentage of Participants
Interval 98.8 to 100.0
|
11.1 Percentage of Participants
Interval 8.3 to 14.4
|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
Anti-HPV 45 cLIA ≥21 mMU/mL
|
98.9 Percentage of Participants
Interval 97.4 to 99.6
|
9.0 Percentage of Participants
Interval 6.5 to 12.1
|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
Anti-HPV 52 cLIA ≥30 mMU/mL
|
98.9 Percentage of Participants
Interval 97.4 to 99.6
|
4.2 Percentage of Participants
Interval 2.5 to 6.5
|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
Anti-HPV 58 cLIA ≥31 mMU/mL
|
99.3 Percentage of Participants
Interval 98.1 to 99.9
|
1.5 Percentage of Participants
Interval 0.6 to 3.1
|
SECONDARY outcome
Timeframe: Month 7Population: 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 heterosexual males (HM) subgroup of the per-protocol immunogenicity population (PPI).
Outcome measures
| Measure |
V503
n=408 Participants
Participants receive an intramuscular (IM) injection of V503 (9-valent human papillomavirus \[9vHPV\] vaccine) at Day 1, Month 2, and Month 6.
|
Placebo
n=415 Participants
Participants receive an IM injection of placebo at Day 1, Month 2, and Month 6.
|
|---|---|---|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
Anti-HPV 6 cLIA ≥65 mMU/mL
|
99.7 Percentage of Participants
Interval 98.5 to 100.0
|
3.5 Percentage of Participants
Interval 1.8 to 6.1
|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
Anti-HPV 11 cLIA ≥37 mMU/mL
|
99.7 Percentage of Participants
Interval 98.5 to 100.0
|
4.4 Percentage of Participants
Interval 2.5 to 7.2
|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
Anti-HPV 16 cLIA ≥79 mMU/mL
|
99.5 Percentage of Participants
Interval 98.2 to 99.9
|
3.7 Percentage of Participants
Interval 2.1 to 6.0
|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
Anti-HPV 18 cLIA ≥85 mMU/mL
|
99.5 Percentage of Participants
Interval 98.1 to 99.9
|
7.6 Percentage of Participants
Interval 5.1 to 10.8
|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
Anti-HPV 31 cLIA ≥46 mMU/mL
|
99.0 Percentage of Participants
Interval 97.4 to 99.7
|
5.2 Percentage of Participants
Interval 3.2 to 7.9
|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
Anti-HPV 33 cLIA ≥26 mMU/mL
|
99.8 Percentage of Participants
Interval 98.6 to 100.0
|
11.4 Percentage of Participants
Interval 8.4 to 14.9
|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
Anti-HPV 45 cLIA ≥21 mMU/mL
|
98.7 Percentage of Participants
Interval 97.1 to 99.6
|
8.5 Percentage of Participants
Interval 5.9 to 11.7
|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
Anti-HPV 52 cLIA ≥30 mMU/mL
|
99.2 Percentage of Participants
Interval 97.8 to 99.8
|
3.8 Percentage of Participants
Interval 2.2 to 6.3
|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
Anti-HPV 58 cLIA ≥31 mMU/mL
|
99.3 Percentage of Participants
Interval 97.9 to 99.8
|
1.7 Percentage of Participants
Interval 0.7 to 3.4
|
SECONDARY outcome
Timeframe: Month 7Population: 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 the males who have sex with males (MSM) subgroup of the per-protocol immunogenicity population (PPI).
Outcome measures
| Measure |
V503
n=48 Participants
Participants receive an intramuscular (IM) injection of V503 (9-valent human papillomavirus \[9vHPV\] vaccine) at Day 1, Month 2, and Month 6.
|
Placebo
n=46 Participants
Participants receive an IM injection of placebo at Day 1, Month 2, and Month 6.
|
|---|---|---|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
Anti-HPV 6 cLIA ≥65 mMU/mL
|
100.0 Percentage of Participants
Interval 91.0 to 100.0
|
3.6 Percentage of Participants
Interval 0.1 to 18.3
|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
Anti-HPV 11 cLIA ≥37 mMU/mL
|
100.0 Percentage of Participants
Interval 91.0 to 100.0
|
0.0 Percentage of Participants
Interval 0.0 to 12.3
|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
Anti-HPV 16 cLIA ≥79 mMU/mL
|
100.0 Percentage of Participants
Interval 92.1 to 100.0
|
9.5 Percentage of Participants
Interval 2.7 to 22.6
|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
Anti-HPV 18 cLIA ≥85 mMU/mL
|
97.7 Percentage of Participants
Interval 88.0 to 99.9
|
14.3 Percentage of Participants
Interval 5.4 to 28.5
|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
Anti-HPV 31 cLIA ≥46 mMU/mL
|
97.9 Percentage of Participants
Interval 88.9 to 99.9
|
8.9 Percentage of Participants
Interval 2.5 to 21.2
|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
Anti-HPV 33 cLIA ≥26 mMU/mL
|
100.0 Percentage of Participants
Interval 92.5 to 100.0
|
8.7 Percentage of Participants
Interval 2.4 to 20.8
|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
Anti-HPV 45 cLIA ≥21 mMU/mL
|
100.0 Percentage of Participants
Interval 91.8 to 100.0
|
13.3 Percentage of Participants
Interval 5.1 to 26.8
|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
Anti-HPV 52 cLIA ≥30 mMU/mL
|
95.6 Percentage of Participants
Interval 84.9 to 99.5
|
7.0 Percentage of Participants
Interval 1.5 to 19.1
|
|
Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
Anti-HPV 58 cLIA ≥31 mMU/mL
|
100.0 Percentage of Participants
Interval 92.6 to 100.0
|
0.0 Percentage of Participants
Interval 0.0 to 8.2
|
Adverse Events
V503
Placebo
Serious adverse events
| Measure |
V503
n=529 participants at risk
Participants receive an intramuscular (IM) injection of V503 (9-valent human papillomavirus \[9vHPV\] vaccine) at Day 1, Month 2, and Month 6.
|
Placebo
n=530 participants at risk
Participants receive an IM injection of placebo at Day 1, Month 2, and Month 6.
|
|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.19%
1/529 • Number of events 1 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
0.00%
0/530 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
|
Infections and infestations
Appendicitis
|
0.19%
1/529 • Number of events 1 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
0.19%
1/530 • Number of events 1 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
|
Infections and infestations
COVID-19
|
0.19%
1/529 • Number of events 1 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
0.19%
1/530 • Number of events 1 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.19%
1/529 • Number of events 1 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
0.00%
0/530 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
|
Infections and infestations
Chronic tonsillitis
|
0.19%
1/529 • Number of events 1 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
0.00%
0/530 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/529 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
0.19%
1/530 • Number of events 1 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/529 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
0.19%
1/530 • Number of events 1 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.19%
1/529 • Number of events 1 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
0.00%
0/530 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/529 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
0.19%
1/530 • Number of events 1 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/529 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
0.19%
1/530 • Number of events 1 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/529 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
0.19%
1/530 • Number of events 1 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.19%
1/529 • Number of events 1 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
0.00%
0/530 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
Other adverse events
| Measure |
V503
n=529 participants at risk
Participants receive an intramuscular (IM) injection of V503 (9-valent human papillomavirus \[9vHPV\] vaccine) at Day 1, Month 2, and Month 6.
|
Placebo
n=530 participants at risk
Participants receive an IM injection of placebo at Day 1, Month 2, and Month 6.
|
|---|---|---|
|
General disorders
Injection site erythema
|
19.7%
104/529 • Number of events 149 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
13.2%
70/530 • Number of events 101 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
|
General disorders
Injection site pain
|
68.1%
360/529 • Number of events 739 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
23.0%
122/530 • Number of events 166 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
|
General disorders
Injection site swelling
|
22.3%
118/529 • Number of events 164 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
7.5%
40/530 • Number of events 50 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
|
General disorders
Pyrexia
|
5.5%
29/529 • Number of events 35 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
6.2%
33/530 • Number of events 36 • Up to approximately 37 months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of the V503 (9vHPV) vaccine or placebo and have provided safety data at any time during the study.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER