Trial Outcomes & Findings for A Phase III Study of a 2-dose Regimen of a Multivalent Human Papillomavirus (HPV) Vaccine (V503), Administered to 9 to 14 Year-olds and Compared to Young Women, 16 to 26 Years Old (V503-010) (NCT NCT01984697)

NCT ID: NCT01984697

Last Updated: 2018-08-08

Results Overview

Antibodies to HPV virus-like particles (VLP) type 6 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1518 participants
• Primary outcome timeframe: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
• Results posted on: 2018-08-08

Participant Flow

A total of 1536 participants were screened and 1518 were randomized into the study.

Participant milestones

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Overall Study STARTED	301	301	301	301	314
Overall Study Vaccination 1	301	301	300	300	314
Overall Study Vaccination 2	293	296	291	298	313
Overall Study Vaccination 3	0	0	0	293	311
Overall Study Month 36 Vaccination	270	281	280	9	31
Overall Study COMPLETED	258	270	272	280	279
Overall Study NOT COMPLETED	43	31	29	21	35

Reasons for withdrawal

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Overall Study Adverse Event	0	0	2	0	0
Overall Study Lost to Follow-up	14	5	10	6	21
Overall Study Physician Decision	3	0	0	1	0
Overall Study Protocol Violation	8	5	3	2	0
Overall Study Withdrawal by Subject	15	21	13	11	13
Overall Study Missed last follow-up visit	1	0	0	0	0
Overall Study Death	0	0	0	1	0
Overall Study Pregnancy	2	0	1	0	1

Baseline Characteristics

A Phase III Study of a 2-dose Regimen of a Multivalent Human Papillomavirus (HPV) Vaccine (V503), Administered to 9 to 14 Year-olds and Compared to Young Women, 16 to 26 Years Old (V503-010)

Baseline characteristics by cohort

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=301 Participants Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=301 Participants Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=301 Participants Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=301 Participants Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=314 Participants Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Total n=1518 Participants Total of all reporting groups
Age, Continuous	11.4 Years STANDARD_DEVIATION 1.7 • n=5 Participants	11.5 Years STANDARD_DEVIATION 1.7 • n=7 Participants	11.4 Years STANDARD_DEVIATION 1.6 • n=5 Participants	11.4 Years STANDARD_DEVIATION 1.7 • n=4 Participants	21.0 Years STANDARD_DEVIATION 2.7 • n=21 Participants	13.4 Years STANDARD_DEVIATION 4.3 • n=8 Participants
Age, Customized Between 9 and 10 years	100 Participants n=5 Participants	98 Participants n=7 Participants	100 Participants n=5 Participants	101 Participants n=4 Participants	0 Participants n=21 Participants	399 Participants n=8 Participants
Age, Customized Between 11 and 12 years	102 Participants n=5 Participants	102 Participants n=7 Participants	106 Participants n=5 Participants	100 Participants n=4 Participants	0 Participants n=21 Participants	410 Participants n=8 Participants
Age, Customized Between 13 and 14 years	99 Participants n=5 Participants	101 Participants n=7 Participants	95 Participants n=5 Participants	100 Participants n=4 Participants	0 Participants n=21 Participants	395 Participants n=8 Participants
Age, Customized Between 16 and 26 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	314 Participants n=21 Participants	314 Participants n=8 Participants
Sex: Female, Male Female	301 Participants n=5 Participants	0 Participants n=7 Participants	151 Participants n=5 Participants	301 Participants n=4 Participants	314 Participants n=21 Participants	1067 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	301 Participants n=7 Participants	150 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	451 Participants n=8 Participants

PRIMARY outcome

Timeframe: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)

Population: All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.

Antibodies to HPV virus-like particles (VLP) type 6 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).

Outcome measures

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=258 Participants Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=263 Participants Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=257 Participants Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=254 Participants Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=238 Participants Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen	1657.9 mMU/mL Interval 1479.6 to 1857.6	1557.4 mMU/mL Interval 1391.5 to 1743.1	2678.8 mMU/mL Interval 2390.2 to 3002.1	1496.1 mMU/mL Interval 1334.1 to 1677.8	770.9 mMU/mL Interval 684.8 to 867.9

PRIMARY outcome

Timeframe: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)

Population: All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.

Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).

Outcome measures

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=258 Participants Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=264 Participants Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=257 Participants Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=254 Participants Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=238 Participants Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Geometric Mean Titers to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen	1388.9 mMU/mL Interval 1240.4 to 1555.3	1423.9 mMU/mL Interval 1273.2 to 1592.3	2941.8 mMU/mL Interval 2626.6 to 3294.9	1306.3 mMU/mL Interval 1165.5 to 1464.0	580.5 mMU/mL Interval 516.0 to 653.0

PRIMARY outcome

Timeframe: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)

Population: All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.

Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).

Outcome measures

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=272 Participants Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=273 Participants Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=264 Participants Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=269 Participants Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=249 Participants Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Geometric Mean Titers to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen	8004.9 mMU/mL Interval 7160.5 to 8948.8	8474.8 mMU/mL Interval 7582.4 to 9472.3	14329.3 mMU/mL Interval 12796.4 to 16045.9	6996.0 mMU/mL Interval 6254.1 to 7825.8	3154.0 mMU/mL Interval 2807.1 to 3543.7

PRIMARY outcome

Timeframe: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)

Population: All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.

Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).

Outcome measures

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=272 Participants Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=272 Participants Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=266 Participants Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=270 Participants Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=267 Participants Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Geometric Mean Titers to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen	1872.8 mMU/mL Interval 1651.6 to 2123.6	1860.9 mMU/mL Interval 1641.1 to 2110.2	2810.4 mMU/mL Interval 2474.9 to 3191.3	2049.3 mMU/mL Interval 1806.4 to 2324.8	761.5 mMU/mL Interval 670.8 to 864.5

PRIMARY outcome

Timeframe: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)

Population: All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.

Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).

Outcome measures

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=272 Participants Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=271 Participants Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=268 Participants Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=271 Participants Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=264 Participants Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Geometric Mean Titers to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen	1436.3 mMU/mL Interval 1272.1 to 1621.8	1498.2 mMU/mL Interval 1326.5 to 1692.0	2117.5 mMU/mL Interval 1873.7 to 2393.1	1748.3 mMU/mL Interval 1548.1 to 1974.5	572.1 mMU/mL Interval 505.8 to 647.2

PRIMARY outcome

Timeframe: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)

Population: All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.

Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).

Outcome measures

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=273 Participants Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=271 Participants Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=269 Participants Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=275 Participants Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=279 Participants Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Geometric Mean Titers to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen	1030.0 mMU/mL Interval 920.4 to 1152.7	1040.0 mMU/mL Interval 928.9 to 1164.3	2197.5 mMU/mL Interval 1961.9 to 2461.3	796.4 mMU/mL Interval 712.0 to 890.9	348.1 mMU/mL Interval 311.5 to 389.1

PRIMARY outcome

Timeframe: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)

Population: All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.

Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).

Outcome measures

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=274 Participants Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=273 Participants Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=268 Participants Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=275 Participants Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=280 Participants Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Geometric Mean Titers to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen	357.6 mMU/mL Interval 313.7 to 407.6	352.3 mMU/mL Interval 309.0 to 401.7	417.7 mMU/mL Interval 365.9 to 476.9	661.7 mMU/mL Interval 580.6 to 754.1	213.6 mMU/mL Interval 187.7 to 243.2

PRIMARY outcome

Timeframe: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)

Population: All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.

Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).

Outcome measures

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=272 Participants Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=273 Participants Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=268 Participants Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=275 Participants Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=271 Participants Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Geometric Mean Titers to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen	581.1 mMU/mL Interval 521.9 to 647.1	640.4 mMU/mL Interval 575.2 to 713.0	1123.4 mMU/mL Interval 1008.1 to 1251.9	909.9 mMU/mL Interval 817.6 to 1012.5	364.2 mMU/mL Interval 327.0 to 405.6

PRIMARY outcome

Timeframe: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)

Population: All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.

Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).

Outcome measures

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=270 Participants Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=270 Participants Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=265 Participants Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=273 Participants Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=261 Participants Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Geometric Mean Titers to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen	1251.2 mMU/mL Interval 1119.6 to 1398.4	1325.7 mMU/mL Interval 1186.2 to 1481.6	2444.6 mMU/mL Interval 2185.2 to 2734.9	1229.3 mMU/mL Interval 1100.7 to 1373.0	491.1 mMU/mL Interval 438.6 to 549.8

SECONDARY outcome

Timeframe: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)

Population: All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.

Antibodies to HPV VLP type 6 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 6 was defined as a titer >=30 mMU/mL.

Outcome measures

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=258 Participants Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=263 Participants Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=257 Participants Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=254 Participants Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=238 Participants Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Percentage of Participants With Seroconversion to HPV Type 6 at Four Weeks After the Last Dose of V503 in the Planned Regimen	99.6 Percentage of participants Interval 97.9 to 100.0	100 Percentage of participants Interval 98.6 to 100.0	100 Percentage of participants Interval 98.6 to 100.0	99.2 Percentage of participants Interval 97.2 to 99.9	99.6 Percentage of participants Interval 97.7 to 100.0

SECONDARY outcome

Timeframe: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)

Population: All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.

Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 11 was defined as a titer >=16 mMU/mL.

Outcome measures

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=258 Participants Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=264 Participants Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=257 Participants Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=254 Participants Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=238 Participants Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Percentage of Participants With Seroconversion to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen	100 Percentage of participants Interval 98.6 to 100.0	100 Percentage of participants Interval 98.6 to 100.0	100 Percentage of participants Interval 98.6 to 100.0	99.6 Percentage of participants Interval 97.8 to 100.0	99.6 Percentage of participants Interval 97.7 to 100.0

SECONDARY outcome

Timeframe: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)

Population: All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.

Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 16 was defined as a titer >=20 mMU/mL.

Outcome measures

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=272 Participants Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=273 Participants Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=264 Participants Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=269 Participants Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=249 Participants Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Percentage of Participants With Seroconversion to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen	100 Percentage of participants Interval 98.7 to 100.0	100 Percentage of participants Interval 98.7 to 100.0	100 Percentage of participants Interval 98.6 to 100.0	100 Percentage of participants Interval 98.6 to 100.0	99.6 Percentage of participants Interval 97.8 to 100.0

SECONDARY outcome

Timeframe: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)

Population: All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.

Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 18 was defined as a titer >=24 mMU/mL.

Outcome measures

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=272 Participants Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=272 Participants Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=266 Participants Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=270 Participants Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=267 Participants Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Percentage of Participants With Seroconversion to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen	100 Percentage of participants Interval 98.7 to 100.0	100 Percentage of participants Interval 98.7 to 100.0	100 Percentage of participants Interval 98.6 to 100.0	99.6 Percentage of participants Interval 98.0 to 100.0	98.5 Percentage of participants Interval 96.2 to 99.6

SECONDARY outcome

Timeframe: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)

Population: All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.

Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 31 was defined as a titer >=10 mMU/mL.

Outcome measures

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=272 Participants Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=271 Participants Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=268 Participants Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=271 Participants Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=264 Participants Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Percentage of Participants With Seroconversion to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen	99.6 Percentage of participants Interval 98.0 to 100.0	100 Percentage of participants Interval 98.6 to 100.0	100 Percentage of participants Interval 98.6 to 100.0	100 Percentage of participants Interval 98.6 to 100.0	99.6 Percentage of participants Interval 97.9 to 100.0

SECONDARY outcome

Timeframe: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)

Population: All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.

Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 33 was defined as a titer >=8 mMU/mL.

Outcome measures

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=273 Participants Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=271 Participants Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=269 Participants Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=275 Participants Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=279 Participants Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Percentage of Participants With Seroconversion to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen	99.6 Percentage of participants Interval 98.0 to 100.0	100 Percentage of participants Interval 98.6 to 100.0	100 Percentage of participants Interval 98.6 to 100.0	100 Percentage of participants Interval 98.7 to 100.0	99.6 Percentage of participants Interval 98.0 to 100.0

SECONDARY outcome

Timeframe: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)

Population: All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.

Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 45 was defined as a titer >=8 mMU/mL.

Outcome measures

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=274 Participants Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=273 Participants Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=268 Participants Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=275 Participants Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=280 Participants Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Percentage of Participants With Seroconversion to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen	99.3 Percentage of participants Interval 97.4 to 99.9	99.3 Percentage of participants Interval 97.4 to 99.9	100 Percentage of participants Interval 98.6 to 100.0	99.3 Percentage of participants Interval 97.4 to 99.9	97.9 Percentage of participants Interval 95.4 to 99.2

SECONDARY outcome

Timeframe: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)

Population: All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.

Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 52 was defined as a titer >=8 mMU/mL.

Outcome measures

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=272 Participants Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=273 Participants Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=268 Participants Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=275 Participants Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=271 Participants Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Percentage of Participants With Seroconversion to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen	99.6 Percentage of participants Interval 98.0 to 100.0	100 Percentage of participants Interval 98.7 to 100.0	100 Percentage of participants Interval 98.6 to 100.0	99.6 Percentage of participants Interval 98.0 to 100.0	99.6 Percentage of participants Interval 98.0 to 100.0

SECONDARY outcome

Timeframe: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)

Population: All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.

Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 58 was defined as a titer >=8 mMU/mL.

Outcome measures

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=270 Participants Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=270 Participants Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=265 Participants Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=273 Participants Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=261 Participants Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Percentage of Participants With Seroconversion to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen	100 Percentage of participants Interval 98.6 to 100.0	100 Percentage of participants Interval 98.6 to 100.0	100 Percentage of participants Interval 98.6 to 100.0	99.6 Percentage of participants Interval 98.0 to 100.0	99.6 Percentage of participants Interval 97.9 to 100.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 24

Population: All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV types, and 4) had no protocol violations that would interfere with evaluation of the immune response.

Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. This outcome measure assessed the long-term persistence of antibody response. Antibody titers were expressed as milli Merck units/mL (mMU/mL).

Outcome measures

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=301 Participants Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=301 Participants Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=300 Participants Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=300 Participants Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=314 Participants Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24 Anti-HPV Type 18	196.8 mMU/mL Interval 174.9 to 221.6	169.6 mMU/mL Interval 150.7 to 190.8	380.8 mMU/mL Interval 337.9 to 429.1	255.8 mMU/mL Interval 227.2 to 288.0	122.2 mMU/mL Interval 108.4 to 137.7
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24 Anti-HPV Type 33	131.2 mMU/mL Interval 116.9 to 147.2	121.5 mMU/mL Interval 108.3 to 136.4	341.7 mMU/mL Interval 304.3 to 383.6	120.8 mMU/mL Interval 107.7 to 135.4	61.3 mMU/mL Interval 54.6 to 68.7
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24 Anti-HPV Type 45	37.8 mMU/mL Interval 33.2 to 43.0	31.9 mMU/mL Interval 28.0 to 36.3	62.3 mMU/mL Interval 54.7 to 71.1	86.9 mMU/mL Interval 76.4 to 98.9	30.7 mMU/mL Interval 27.0 to 34.9
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24 Anti-HPV Type 58	155.4 mMU/mL Interval 138.0 to 175.1	149.8 mMU/mL Interval 133.1 to 168.6	380.2 mMU/mL Interval 337.3 to 428.6	183.7 mMU/mL Interval 163.3 to 206.7	76.8 mMU/mL Interval 68.0 to 86.7
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24 Anti-HPV Type 6	260.7 mMU/mL Interval 231.5 to 293.6	209.1 mMU/mL Interval 185.9 to 235.1	574.0 mMU/mL Interval 509.6 to 646.5	300.7 mMU/mL Interval 266.8 to 339.0	153.2 mMU/mL Interval 135.4 to 173.5
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24 Anti-HPV Type 11	169.8 mMU/mL Interval 150.5 to 191.7	150.6 mMU/mL Interval 133.6 to 169.7	443.7 mMU/mL Interval 392.9 to 501.0	201.9 mMU/mL Interval 178.7 to 228.1	98.3 mMU/mL Interval 86.6 to 111.6
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24 Anti-HPV Type 16	900.5 mMU/mL Interval 788.0 to 1028.9	801.0 mMU/mL Interval 701.5 to 914.6	2316.2 mMU/mL Interval 2023.5 to 2651.4	1041.3 mMU/mL Interval 910.8 to 1190.4	461.6 mMU/mL Interval 401.2 to 531.0
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24 Anti-HPV Type 31	160.6 mMU/mL Interval 140.8 to 183.3	139.1 mMU/mL Interval 122.0 to 158.7	312.8 mMU/mL Interval 273.9 to 357.1	260.6 mMU/mL Interval 228.4 to 297.3	89.6 mMU/mL Interval 78.4 to 102.5
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24 Anti-HPV Type 52	85.1 mMU/mL Interval 76.4 to 94.7	80.9 mMU/mL Interval 72.7 to 90.0	199.4 mMU/mL Interval 179.0 to 222.2	150.4 mMU/mL Interval 135.2 to 167.4	73.7 mMU/mL Interval 66.1 to 82.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 24

Population: All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV types, and 4) had no protocol violations that would interfere with evaluation of the immune response.

Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. This outcome measure assessed the long-term persistence of antibody response. Seroconversion to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were defined as a titer >=41, 24, 34, 39, 24, 18, 12, 16, and 12 mMU/mL, respectively. These cutoffs differ from analyses performed on samples collected up to Month 13; the antibody persistence analysis employed a new version of the assay.

Outcome measures

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=301 Participants Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=301 Participants Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=300 Participants Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=300 Participants Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=314 Participants Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24 Anti-HPV Type 11	98.0 Percentage of participants Interval 95.4 to 99.4	95.8 Percentage of participants Interval 92.6 to 97.9	99.6 Percentage of participants Interval 97.8 to 100.0	98.8 Percentage of participants Interval 96.5 to 99.8	94.8 Percentage of participants Interval 91.1 to 97.3
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24 Anti-HPV Type 16	98.9 Percentage of participants Interval 96.7 to 99.8	99.6 Percentage of participants Interval 97.9 to 100.0	100 Percentage of participants Interval 98.6 to 100.0	99.6 Percentage of participants Interval 97.9 to 100.0	99.6 Percentage of participants Interval 97.7 to 100.0
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24 Anti-HPV Type 18	98.5 Percentage of participants Interval 96.2 to 99.6	95.9 Percentage of participants Interval 92.8 to 97.9	98.9 Percentage of participants Interval 96.7 to 99.8	99.2 Percentage of participants Interval 97.3 to 99.9	95.0 Percentage of participants Interval 91.6 to 97.3
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24 Anti-HPV Type 31	97.0 Percentage of participants Interval 94.2 to 98.7	94.8 Percentage of participants Interval 91.4 to 97.1	98.5 Percentage of participants Interval 96.2 to 99.6	97.7 Percentage of participants Interval 95.2 to 99.2	91.5 Percentage of participants Interval 87.4 to 94.6
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24 Anti-HPV Type 45	88.4 Percentage of participants Interval 84.0 to 92.0	85.9 Percentage of participants Interval 81.1 to 89.8	93.9 Percentage of participants Interval 90.3 to 96.5	96.7 Percentage of participants Interval 93.8 to 98.5	82.7 Percentage of participants Interval 77.6 to 87.0
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24 Anti-HPV Type 52	96.6 Percentage of participants Interval 93.7 to 98.4	95.2 Percentage of participants Interval 91.9 to 97.4	99.2 Percentage of participants Interval 97.3 to 99.9	99.3 Percentage of participants Interval 97.3 to 99.9	97.3 Percentage of participants Interval 94.6 to 98.9
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24 Anti-HPV Type 58	98.9 Percentage of participants Interval 96.7 to 99.8	99.6 Percentage of participants Interval 97.9 to 100.0	100 Percentage of participants Interval 98.6 to 100.0	100 Percentage of participants Interval 98.6 to 100.0	96.0 Percentage of participants Interval 92.9 to 98.1
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24 Anti-HPV Type 6	98.4 Percentage of participants Interval 96.0 to 99.6	96.9 Percentage of participants Interval 94.0 to 98.7	99.2 Percentage of participants Interval 97.2 to 99.9	99.6 Percentage of participants Interval 97.8 to 100.0	94.0 Percentage of participants Interval 90.1 to 96.7
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24 Anti-HPV Type 33	97.8 Percentage of participants Interval 95.2 to 99.2	96.6 Percentage of participants Interval 93.7 to 98.4	99.2 Percentage of participants Interval 97.3 to 99.9	98.9 Percentage of participants Interval 96.8 to 99.8	94.8 Percentage of participants Interval 91.4 to 97.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 36

Population: All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV types, and 4) had no protocol violations that would interfere with evaluation of the immune response.

Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. This outcome measure assessed the long-term persistence of antibody response. Antibody titers were expressed as milli Merck units/mL (mMU/mL).

Outcome measures

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=301 Participants Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=301 Participants Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=300 Participants Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=300 Participants Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=314 Participants Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36 Anti-HPV Type 6	209.6 mMU/mL Interval 184.9 to 237.6	160.1 mMU/mL Interval 141.9 to 180.7	401.2 mMU/mL Interval 354.8 to 453.7	232.2 mMU/mL Interval 205.1 to 263.0	133.8 mMU/mL Interval 117.3 to 152.7
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36 Anti-HPV Type 11	133.7 mMU/mL Interval 117.6 to 152.1	115.2 mMU/mL Interval 101.8 to 130.3	308.2 mMU/mL Interval 271.8 to 349.6	159.1 mMU/mL Interval 140.0 to 180.7	82.9 mMU/mL Interval 72.4 to 94.9
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36 Anti-HPV Type 16	673.8 mMU/mL Interval 582.8 to 779.1	592.6 mMU/mL Interval 514.7 to 682.4	1534.3 mMU/mL Interval 1328.8 to 1771.5	792.4 mMU/mL Interval 686.7 to 914.4	368.9 mMU/mL Interval 316.4 to 430.0
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36 Anti-HPV Type 18	158.9 mMU/mL Interval 140.8 to 179.4	141.7 mMU/mL Interval 125.9 to 159.4	276.4 mMU/mL Interval 245.3 to 311.6	206.5 mMU/mL Interval 183.3 to 232.7	104.1 mMU/mL Interval 92.0 to 117.8
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36 Anti-HPV Type 31	127.8 mMU/mL Interval 111.4 to 146.5	106.9 mMU/mL Interval 93.5 to 122.1	218.0 mMU/mL Interval 190.6 to 249.4	205.9 mMU/mL Interval 180.0 to 235.5	74.6 mMU/mL Interval 64.8 to 85.9
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36 Anti-HPV Type 33	106.0 mMU/mL Interval 94.1 to 119.5	95.7 mMU/mL Interval 85.1 to 107.5	240.4 mMU/mL Interval 213.8 to 270.3	95.5 mMU/mL Interval 85.0 to 107.3	52.2 mMU/mL Interval 46.3 to 58.9
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36 Anti-HPV Type 45	30.6 mMU/mL Interval 26.9 to 35.0	26.8 mMU/mL Interval 23.6 to 30.4	43.6 mMU/mL Interval 38.3 to 49.7	66.1 mMU/mL Interval 58.1 to 75.2	27.3 mMU/mL Interval 23.9 to 31.1
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36 Anti-HPV Type 52	66.2 mMU/mL Interval 59.1 to 74.0	63.4 mMU/mL Interval 56.8 to 70.7	143.2 mMU/mL Interval 128.3 to 159.9	115.9 mMU/mL Interval 103.9 to 129.3	61.5 mMU/mL Interval 54.8 to 68.9
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36 Anti-HPV Type 58	125.8 mMU/mL Interval 111.1 to 142.5	119.2 mMU/mL Interval 105.6 to 134.5	265.3 mMU/mL Interval 234.8 to 299.8	143.0 mMU/mL Interval 126.7 to 161.5	64.7 mMU/mL Interval 56.9 to 73.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 36

Population: All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV types, and 4) had no protocol violations that would interfere with evaluation of the immune response.

Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. This outcome measure assessed the long-term persistence of antibody response. Seroconversion to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were defined as a titer >=41, 24, 34, 39, 24, 18, 12, 16, and 12 mMU/mL, respectively. These cutoffs differ from analyses performed on samples collected up to Month 13; the antibody persistence analysis employed a new version of the assay.

Outcome measures

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=301 Participants Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=301 Participants Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=300 Participants Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=300 Participants Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=314 Participants Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36 Anti-HPV Type 6	95.3 Percentage of participants Interval 91.8 to 97.7	91.3 Percentage of participants Interval 87.2 to 94.5	99.2 Percentage of participants Interval 97.1 to 99.9	97.9 Percentage of participants Interval 95.2 to 99.3	92.1 Percentage of participants Interval 87.6 to 95.3
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36 Anti-HPV Type 45	83.6 Percentage of participants Interval 78.4 to 88.0	81.4 Percentage of participants Interval 76.1 to 85.9	87.9 Percentage of participants Interval 83.3 to 91.7	91.2 Percentage of participants Interval 87.1 to 94.3	77.8 Percentage of participants Interval 72.1 to 82.8
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36 Anti-HPV Type 33	94.0 Percentage of participants Interval 90.3 to 96.6	96.9 Percentage of participants Interval 94.1 to 98.7	99.2 Percentage of participants Interval 97.2 to 99.9	98.1 Percentage of participants Interval 95.6 to 99.4	91.9 Percentage of participants Interval 87.7 to 95.0
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36 Anti-HPV Type 52	93.5 Percentage of participants Interval 89.7 to 96.3	93.9 Percentage of participants Interval 90.3 to 96.5	98.8 Percentage of participants Interval 96.6 to 99.8	97.7 Percentage of participants Interval 95.1 to 99.2	95.0 Percentage of participants Interval 91.4 to 97.4
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36 Anti-HPV Type 58	98.0 Percentage of participants Interval 95.3 to 99.3	99.2 Percentage of participants Interval 97.3 to 99.9	100 Percentage of participants Interval 98.6 to 100.0	98.8 Percentage of participants Interval 96.7 to 99.8	94.8 Percentage of participants Interval 91.1 to 97.3
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36 Anti-HPV Type 11	94.1 Percentage of participants Interval 90.2 to 96.7	92.9 Percentage of participants Interval 89.1 to 95.8	99.2 Percentage of participants Interval 97.1 to 99.9	98.8 Percentage of participants Interval 96.4 to 99.7	92.1 Percentage of participants Interval 87.6 to 95.3
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36 Anti-HPV Type 16	97.2 Percentage of participants Interval 94.3 to 98.9	98.5 Percentage of participants Interval 96.2 to 99.6	100 Percentage of participants Interval 98.6 to 100.0	99.2 Percentage of participants Interval 97.2 to 99.9	98.2 Percentage of participants Interval 95.5 to 99.5
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36 Anti-HPV Type 18	95.6 Percentage of participants Interval 92.2 to 97.8	94.3 Percentage of participants Interval 90.7 to 96.8	97.6 Percentage of participants Interval 94.9 to 99.1	97.3 Percentage of participants Interval 94.4 to 98.9	90.8 Percentage of participants Interval 86.4 to 94.1
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36 Anti-HPV Type 31	94.0 Percentage of participants Interval 90.2 to 96.6	91.2 Percentage of participants Interval 87.1 to 94.3	96.5 Percentage of participants Interval 93.5 to 98.4	97.7 Percentage of participants Interval 95.0 to 99.1	86.0 Percentage of participants Interval 80.8 to 90.1

Adverse Events

Girls 9 to 14 Years V503 at Months 0 and 6

Serious events: 6 serious events

Other events: 53 other events

Deaths: 0 deaths

Boys 9 to 14 Years V503 at Months 0 and 6

Serious events: 9 serious events

Other events: 32 other events

Deaths: 0 deaths

Girls and Boys 9 to 14 Years V503 at Months 0 and 12

Serious events: 6 serious events

Other events: 46 other events

Deaths: 0 deaths

Girls 9 to 14 Years V503 at Months 0, 2, and 6

Serious events: 6 serious events

Other events: 55 other events

Deaths: 1 deaths

Young Women 16 to 26 Years V503 at Months 0, 2, and 6

Serious events: 11 serious events

Other events: 90 other events

Deaths: 0 deaths

Serious adverse events

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=294 participants at risk Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=296 participants at risk Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=293 participants at risk Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=300 participants at risk Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=313 participants at risk Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Gastrointestinal disorders Abdominal pain	0.68% 2/294 • Number of events 2 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/296 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/300 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.32% 1/313 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Gastrointestinal disorders Diarrhoea	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.34% 1/296 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/300 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.32% 1/313 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Hepatobiliary disorders Cholecystitis acute	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/296 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/300 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.32% 1/313 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Infections and infestations Appendicitis	0.34% 1/294 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.34% 1/296 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.34% 1/293 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.33% 1/300 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/313 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Infections and infestations Dengue fever	0.34% 1/294 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/296 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/300 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/313 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Infections and infestations Gastroenteritis rotavirus	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.34% 1/296 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/300 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/313 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Infections and infestations Pharyngitis	0.34% 1/294 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/296 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/300 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/313 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Infections and infestations Pharyngotonsillitis	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/296 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/300 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.32% 1/313 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Infections and infestations Subcutaneous abscess	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/296 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.33% 1/300 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/313 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Injury, poisoning and procedural complications Animal bite	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.34% 1/296 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/300 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/313 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Injury, poisoning and procedural complications Concussion	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.34% 1/296 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/300 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/313 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/296 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.34% 1/293 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/300 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/313 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Nervous system disorders Epilepsy	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.34% 1/296 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/300 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/313 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Pregnancy, puerperium and perinatal conditions Premature delivery	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/296 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/300 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.32% 1/313 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Psychiatric disorders Depression	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/296 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.33% 1/300 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/313 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Reproductive system and breast disorders Ovarian cyst	0.34% 1/294 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/296 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.33% 1/300 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/313 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/296 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.34% 1/293 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/300 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/313 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Surgical and medical procedures Abortion induced	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/296 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/300 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	1.3% 4/313 • Number of events 4 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Vascular disorders Venous thrombosis limb	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/296 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/300 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.32% 1/313 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Gastrointestinal disorders Gastritis	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/296 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.34% 1/293 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/300 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/313 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Infections and infestations Chikungunya virus infection	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.34% 1/296 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/300 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/313 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Infections and infestations Meningitis bacterial	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.34% 1/296 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/300 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/313 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Infections and infestations Oral herpes	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/296 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.34% 1/293 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/300 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/313 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Infections and infestations Pneumonia	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.34% 1/296 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/300 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/313 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Injury, poisoning and procedural complications Foreign body	0.34% 1/294 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/296 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/300 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/313 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/296 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/300 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.32% 1/313 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Nervous system disorders Encephalitis autoimmune	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/296 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.33% 1/300 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/313 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Nervous system disorders Radiculopathy	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/296 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.34% 1/293 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/300 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/313 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Nervous system disorders Status epilepticus	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/296 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.33% 1/300 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/313 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/296 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.33% 1/300 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/313 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Cardiac disorders Cardiac arrest	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/296 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.33% 1/300 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/313 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Cardiac disorders Wolff-Parkinson-White syndrome	0.00% 0/294 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.34% 1/296 • Number of events 1 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/293 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/300 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	0.00% 0/313 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data

Other adverse events

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n=294 participants at risk Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Boys 9 to 14 Years V503 at Months 0 and 6 n=296 participants at risk Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n=293 participants at risk Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n=300 participants at risk Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n=313 participants at risk Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
General disorders Injection site pain	16.7% 49/294 • Number of events 65 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	9.5% 28/296 • Number of events 31 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	14.0% 41/293 • Number of events 52 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	17.7% 53/300 • Number of events 81 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	25.6% 80/313 • Number of events 148 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
Nervous system disorders Headache	2.7% 8/294 • Number of events 9 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	3.0% 9/296 • Number of events 9 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	2.4% 7/293 • Number of events 8 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	2.3% 7/300 • Number of events 8 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data	5.1% 16/313 • Number of events 19 • Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
• Publication restrictions are in place

Restriction type: OTHER