Trial Outcomes & Findings for A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018) (NCT NCT00092547)

Results Overview

Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1781 participants

Primary outcome timeframe

Up to Month 18

Results posted on

2018-02-20

Participant Flow

1781 participants were randomized to receive qHPV or Placebo in the Base Study. At month 30, participants who received Placebo in the Base Study were eligible to receive qHPV, and formed the Extension Group. Participants were to be followed for safety and efficacy for up to 10 years.

Participant milestones

Participant milestones
Measure	qHPV Vaccine in Base Study Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6.	Placebo in Base Study Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6.	qHPV Vaccine in Extension Study Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
Base Vaccine Phase (Day 1 to Month 7) STARTED	1184	597	0
Base Vaccine Phase (Day 1 to Month 7) Vaccinated	1179	596	0
Base Vaccine Phase (Day 1 to Month 7) COMPLETED	1121	561	0
Base Vaccine Phase (Day 1 to Month 7) NOT COMPLETED	63	36	0
Base Follow-up Phase (Month 7 to 18) STARTED	1128	565	0
Base Follow-up Phase (Month 7 to 18) COMPLETED	1108	551	0
Base Follow-up Phase (Month 7 to 18) NOT COMPLETED	20	14	0
Base Follow-up Phase (Month 18 to 30) STARTED	964	490	0
Base Follow-up Phase (Month 18 to 30) COMPLETED	956	485	0
Base Follow-up Phase (Month 18 to 30) NOT COMPLETED	8	5	0
Extension Vaccine Phase (Month 30 to 37) STARTED	956	0	485
Extension Vaccine Phase (Month 30 to 37) Vaccinated in Extension Study	0	0	482
Extension Vaccine Phase (Month 30 to 37) COMPLETED	933	0	469
Extension Vaccine Phase (Month 30 to 37) NOT COMPLETED	23	0	16
Long-term Follow-up (Month 42 Visit) STARTED	612	0	308
Long-term Follow-up (Month 42 Visit) COMPLETED	611	0	308
Long-term Follow-up (Month 42 Visit) NOT COMPLETED	1	0	0
Long-term Follow-up (Month 72 Visit) STARTED	550	0	276
Long-term Follow-up (Month 72 Visit) COMPLETED	550	0	276
Long-term Follow-up (Month 72 Visit) NOT COMPLETED	0	0	0
Long-term Follow-up (Month 96 Visit) STARTED	508	0	267
Long-term Follow-up (Month 96 Visit) COMPLETED	508	0	267
Long-term Follow-up (Month 96 Visit) NOT COMPLETED	0	0	0
Long-term Follow-up (Month 126 Visit) STARTED	454	0	211
Long-term Follow-up (Month 126 Visit) COMPLETED	454	0	211
Long-term Follow-up (Month 126 Visit) NOT COMPLETED	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	qHPV Vaccine in Base Study Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6.	Placebo in Base Study Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6.	qHPV Vaccine in Extension Study Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
Base Vaccine Phase (Day 1 to Month 7) Not Vaccinated	5	1	0
Base Vaccine Phase (Day 1 to Month 7) Adverse Event	4	1	0
Base Vaccine Phase (Day 1 to Month 7) Lost to Follow-up	18	7	0
Base Vaccine Phase (Day 1 to Month 7) Withdrawal by Subject	28	21	0
Base Vaccine Phase (Day 1 to Month 7) Moved	3	1	0
Base Vaccine Phase (Day 1 to Month 7) per sponsor request: (noncompliant)	0	1	0
Base Vaccine Phase (Day 1 to Month 7) Did not meet local regulations	0	1	0
Base Vaccine Phase (Day 1 to Month 7) Refused Vaccination	5	3	0
Base Follow-up Phase (Month 7 to 18) Subject moved	1	5	0
Base Follow-up Phase (Month 7 to 18) Withdrawal by Subject	4	2	0
Base Follow-up Phase (Month 7 to 18) Lost to Follow-up	13	7	0
Base Follow-up Phase (Month 7 to 18) Protocol Violation	1	0	0
Base Follow-up Phase (Month 7 to 18) Physician Decision	1	0	0
Base Follow-up Phase (Month 18 to 30) Subject moved	4	2	0
Base Follow-up Phase (Month 18 to 30) Withdrawal by Subject	1	3	0
Base Follow-up Phase (Month 18 to 30) Lost to Follow-up	2	0	0
Base Follow-up Phase (Month 18 to 30) Protocol Violation	1	0	0
Extension Vaccine Phase (Month 30 to 37) Subject moved	3	0	0
Extension Vaccine Phase (Month 30 to 37) Withdrawal by Subject	6	0	9
Extension Vaccine Phase (Month 30 to 37) Lost to Follow-up	14	0	7
Long-term Follow-up (Month 42 Visit) Adverse Event	1	0	0

Baseline Characteristics

A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	qHPV Vaccine in Base Study n=1184 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study n=597 Participants Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6	Total n=1781 Participants Total of all reporting groups
Age, Continuous	11.9 years STANDARD_DEVIATION 1.9 • n=93 Participants	11.8 years STANDARD_DEVIATION 1.9 • n=4 Participants	11.9 years STANDARD_DEVIATION 1.9 • n=27 Participants
Age, Customized 8 Years of Age and Under	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Customized 9 to 16 Years of Age	1184 Participants n=93 Participants	597 Participants n=4 Participants	1781 Participants n=27 Participants
Age, Customized 17 Years of Age and Over	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	616 Participants n=93 Participants	322 Participants n=4 Participants	938 Participants n=27 Participants
Sex: Female, Male Male	568 Participants n=93 Participants	275 Participants n=4 Participants	843 Participants n=27 Participants
Race/Ethnicity, Customized Asian	149 participants n=93 Participants	70 participants n=4 Participants	219 participants n=27 Participants
Race/Ethnicity, Customized Black	50 participants n=93 Participants	21 participants n=4 Participants	71 participants n=27 Participants
Race/Ethnicity, Customized Hispanic American	260 participants n=93 Participants	130 participants n=4 Participants	390 participants n=27 Participants
Race/Ethnicity, Customized Native American	0 participants n=93 Participants	1 participants n=4 Participants	1 participants n=27 Participants
Race/Ethnicity, Customized White	716 participants n=93 Participants	369 participants n=4 Participants	1085 participants n=27 Participants
Race/Ethnicity, Customized Other	9 participants n=93 Participants	6 participants n=4 Participants	15 participants n=27 Participants

PRIMARY outcome

Timeframe: Up to Month 18

Population: All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.

Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment.

Outcome measures

Outcome measures
Measure	qHPV Vaccine in Base Study n=1165 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study n=584 Participants Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18	6 participants	0 participants

PRIMARY outcome

Timeframe: Month 18 to Month 37

Population: All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.

Tolerability as assessed by the number of participants with clinical adverse experiences from Month 18 through Month 37

Outcome measures

Outcome measures
Measure	qHPV Vaccine in Base Study n=923 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study n=477 Participants Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
Number of Participants Reporting SAEs From Month 18 Through Month 37	0 participants	3 participants

PRIMARY outcome

Timeframe: Up to Month 18: Injection site AEs were collected from Days 1-5 and other non-serious AEs from Days 1-15 after any vaccination

Population: All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.

Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18

Outcome measures

Outcome measures
Measure	qHPV Vaccine in Base Study n=1165 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study n=584 Participants Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
Number of Participants Reporting Other (Non-serious) AEs Through Month 18	918 participants	340 participants

PRIMARY outcome

Timeframe: Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)

Population: Per-protocol population: participants without protocol violations who received all 3 vaccinations, were seronegative to the respective HPV type at Day 1 (for the Base Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.

A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

Outcome measures

Outcome measures
Measure	qHPV Vaccine in Base Study n=550 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study n=276 Participants Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 Type 6: n=475, 151	93.3 Percentage of participants Interval 90.6 to 95.3	91.4 Percentage of participants Interval 85.7 to 95.3
Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 Type 11: n=475, 151	96.0 Percentage of participants Interval 93.8 to 97.6	96.7 Percentage of participants Interval 92.4 to 98.9
Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 Type 16: n=473, 154	97.9 Percentage of participants Interval 96.1 to 99.0	97.4 Percentage of participants Interval 93.5 to 99.3
Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 Type 18: n=477, 160	74.4 Percentage of participants Interval 70.3 to 78.3	79.4 Percentage of participants Interval 72.3 to 85.4

PRIMARY outcome

Timeframe: Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)

Population: Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.

Outcome measures

Outcome measures
Measure	qHPV Vaccine in Base Study n=550 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study n=276 Participants Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72 Type 6: n=475, 151	118.9 milliMerck units/mL Interval 108.4 to 130.4	113.9 milliMerck units/mL Interval 95.7 to 135.6
Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72 Type 11: n=475, 151	135.7 milliMerck units/mL Interval 122.6 to 150.3	137.9 milliMerck units/mL Interval 114.9 to 165.5
Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72 Type 16: n=473, 154	521.2 milliMerck units/mL Interval 466.2 to 582.6	485.8 milliMerck units/mL Interval 396.4 to 595.3
Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72 Type 18: n=477, 160	70.9 milliMerck units/mL Interval 61.8 to 81.4	67.7 milliMerck units/mL Interval 53.1 to 86.3

PRIMARY outcome

Timeframe: Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Group and 60 Months Post-dose 3 for Extension Group)

Population: Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.

Outcome measures

Outcome measures
Measure	qHPV Vaccine in Base Study n=508 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study n=267 Participants Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96 Type 6: n=451, 141	71.4 milliMerck units/mL Interval 64.6 to 79.0	91.0 milliMerck units/mL Interval 76.4 to 108.6
Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96 Type 11: n=451, 141	67.5 milliMerck units/mL Interval 60.1 to 75.7	90.3 milliMerck units/mL Interval 74.0 to 110.1
Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96 Type 16: n=447, 143	325.5 milliMerck units/mL Interval 288.6 to 367.1	387.4 milliMerck units/mL Interval 314.7 to 476.9
Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96 Type 18: n=452, 152	41.6 milliMerck units/mL Interval 36.5 to 47.5	48.3 milliMerck units/mL Interval 37.6 to 62.0

PRIMARY outcome

Timeframe: Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Cohort and 60 Months Post-dose 3 for Extension Group)

Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.

A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

Outcome measures

Outcome measures
Measure	qHPV Vaccine in Base Study n=508 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study n=267 Participants Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96 Type 6: n=451, 141	88.2 Percentage of participants Interval 84.9 to 91.1	91.5 Percentage of participants Interval 85.6 to 95.5
Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96 Type 11: n=451, 141	89.1 Percentage of participants Interval 85.9 to 91.9	93.6 Percentage of participants Interval 88.2 to 97.0
Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96 Type 16: n=447, 143	96.9 Percentage of participants Interval 94.8 to 98.3	97.9 Percentage of participants Interval 94.0 to 99.6
Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96 Type 18: n=452, 152	63.9 Percentage of participants Interval 59.3 to 68.4	69.1 Percentage of participants Interval 61.1 to 76.3

PRIMARY outcome

Timeframe: Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)

Population: Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.

Outcome measures

Outcome measures
Measure	qHPV Vaccine in Base Study n=454 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study n=211 Participants Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126 Type 18: n=408, 120	36.5 milliMerck units/mL Interval 31.7 to 42.1	39.6 milliMerck units/mL Interval 30.7 to 51.2
Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126 Type 6: n=409, 112	88.0 milliMerck units/mL Interval 78.9 to 98.2	99.3 milliMerck units/mL Interval 81.0 to 121.6
Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126 Type 11: n=409, 112	74.6 milliMerck units/mL Interval 66.1 to 84.1	96.0 milliMerck units/mL Interval 76.1 to 121.1
Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126 Type 16: n=403, 115	320.1 milliMerck units/mL Interval 281.2 to 364.4	351.6 milliMerck units/mL Interval 277.1 to 446.2

PRIMARY outcome

Timeframe: Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)

Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.

A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

Outcome measures

Outcome measures
Measure	qHPV Vaccine in Base Study n=454 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study n=211 Participants Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126 Type 6: n=409, 112	89.0 Percentage of participants Interval 85.6 to 91.9	91.1 Percentage of participants Interval 84.2 to 95.6
Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126 Type 11: n=409, 112	88.8 Percentage of participants Interval 85.3 to 91.6	92.9 Percentage of participants Interval 86.4 to 96.9
Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126 Type 16: n=403, 115	96.0 Percentage of participants Interval 93.6 to 97.7	96.5 Percentage of participants Interval 91.3 to 99.0
Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126 Type 18: n=408, 120	60.5 Percentage of participants Interval 55.6 to 65.3	65.0 Percentage of participants Interval 55.8 to 73.5

PRIMARY outcome

Timeframe: Month 37 to Month 126

Population: The analysis population was all participants who were vaccinated according to actual treatment received and had safety follow-up.

A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment. SAEs considered by the investigator to be possibly, probably, or definitely related to study vaccine or a study procedure were reported.

Outcome measures

Outcome measures
Measure	qHPV Vaccine in Base Study n=821 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study n=424 Participants Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Month 7 (1 Month Postdose 3)

Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.

A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

Outcome measures

Outcome measures
Measure	qHPV Vaccine in Base Study n=1082 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7) Type 6: n=953	99.8 Percentage of participants Interval 99.2 to 100.0	—
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7) Type 11: n=954	99.8 Percentage of participants Interval 99.2 to 100.0	—
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7) Type 16: n=949	99.7 Percentage of participants Interval 99.1 to 99.9	—
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7) Type 18: n=956	99.7 Percentage of participants Interval 99.1 to 99.9	—

SECONDARY outcome

Timeframe: Month 18 (12 Months Post-dose 3)

Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.

A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

Outcome measures

Outcome measures
Measure	qHPV Vaccine in Base Study n=1106 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (Month 18). Type 6: n=937	97.8 Percentage of participants Interval 96.6 to 98.6	—
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (Month 18). Type 11: n=938	99.3 Percentage of participants Interval 98.5 to 99.7	—
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (Month 18). Type 16: n=933	99.6 Percentage of participants Interval 98.9 to 99.9	—
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (Month 18). Type 18: n=940	91.6 Percentage of participants Interval 89.6 to 93.3	—

SECONDARY outcome

Timeframe: Month 24 (18 Months Post-dose 3)

Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.

A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

Outcome measures

Outcome measures
Measure	qHPV Vaccine in Base Study n=595 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24) Type 6: n=446	95.1 Percentage of participants Interval 92.6 to 96.9	—
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24) Type 11: n=447	98.2 Percentage of participants Interval 96.5 to 99.2	—
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24) Type 16: n=442	98.4 Percentage of participants Interval 96.8 to 99.4	—
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24) Type 18: n=447	87.5 Percentage of participants Interval 84.0 to 90.4	—

SECONDARY outcome

Timeframe: Month 30 (24 Months Post-dose 3)

Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.

A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

Outcome measures

Outcome measures
Measure	qHPV Vaccine in Base Study n=911 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30) Type 6: n=799	95.6 Percentage of participants Interval 94.0 to 96.9	—
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30) Type 11: n=800	97.5 Percentage of participants Interval 96.2 to 98.5	—
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30) Type 16: n=795	98.6 Percentage of participants Interval 97.5 to 99.3	—
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30) Type 18: n=803	84.3 Percentage of participants Interval 81.6 to 86.8	—

SECONDARY outcome

Timeframe: Month 37 (31 Months Post-dose 3)

Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.

A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

Outcome measures

Outcome measures
Measure	qHPV Vaccine in Base Study n=772 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37). Type 6: n=657	94.5 Percentage of participants Interval 92.5 to 96.1	—
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37). Type 11: n=657	96.0 Percentage of participants Interval 94.3 to 97.4	—
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37). Type 16: n=655	98.2 Percentage of participants Interval 96.8 to 99.0	—
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37). Type 18: n=660	81.1 Percentage of participants Interval 77.9 to 84.0	—

SECONDARY outcome

Timeframe: Month 37 (1 Month Post-dose 3 of qHPV)

Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Month 30, and had a valid serology result at the specified time for assessment.

A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

Outcome measures

Outcome measures
Measure	qHPV Vaccine in Base Study n=440 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
Percentage of Participants in the Extension Group Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV (Month 37) Type 6: n=246	99.6 Percentage of participants Interval 97.8 to 100.0	—
Percentage of Participants in the Extension Group Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV (Month 37) Type 11: n=246	100 Percentage of participants Interval 98.5 to 100.0	—
Percentage of Participants in the Extension Group Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV (Month 37) Type 16: n=246	100 Percentage of participants Interval 98.5 to 100.0	—
Percentage of Participants in the Extension Group Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV (Month 37) Type 18: n=255	98.8 Percentage of participants Interval 96.6 to 99.8	—

SECONDARY outcome

Timeframe: Month 7 (1 Month Post-dose 3)

Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.

Outcome measures

Outcome measures
Measure	qHPV Vaccine in Base Study n=1082 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 7) Type 6: n=953	929.2 milliMerck units/mL Interval 871.0 to 991.4	—
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 7) Type 11: n=954	1362.8 milliMerck units/mL Interval 1279.8 to 1451.3	—
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 7) Type 16: n=949	5512.7 milliMerck units/mL Interval 5109.9 to 5947.2	—
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 7) Type 18: n=956	1278.9 milliMerck units/mL Interval 1183.2 to 1382.4	—

SECONDARY outcome

Timeframe: Month 18 (Month 12 Post-dose 3)

Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.

Outcome measures

Outcome measures
Measure	qHPV Vaccine in Base Study n=1106 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 12 Postdose 3 of qHPV Vaccine (Month 18) Type 6: n=937	219.3 milliMerck units/mL Interval 204.9 to 234.7	—
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 12 Postdose 3 of qHPV Vaccine (Month 18) Type 11: n=938	296.9 milliMerck units/mL Interval 276.9 to 318.3	—
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 12 Postdose 3 of qHPV Vaccine (Month 18) Type 16: n=933	1314.8 milliMerck units/mL Interval 1220.5 to 1416.5	—
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 12 Postdose 3 of qHPV Vaccine (Month 18) Type 18: n=940	203.0 milliMerck units/mL Interval 184.1 to 223.9	—

SECONDARY outcome

Timeframe: Month 24 (18 Months Post-dose 3)

Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.

Outcome measures

Outcome measures
Measure	qHPV Vaccine in Base Study n=595 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 18 Postdose 3 of qHPV Vaccine (Month 24) Type 6: n=446	143.5 milliMerck units/mL Interval 129.2 to 159.5	—
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 18 Postdose 3 of qHPV Vaccine (Month 24) Type 11: n=447	206.6 milliMerck units/mL Interval 186.9 to 228.3	—
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 18 Postdose 3 of qHPV Vaccine (Month 24) Type 16: n=442	932.1 milliMerck units/mL Interval 833.3 to 1042.7	—
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 18 Postdose 3 of qHPV Vaccine (Month 24) Type 18: n=447	136.2 milliMerck units/mL Interval 118.5 to 156.6	—

SECONDARY outcome

Timeframe: Month 30 (24 Months Post-dose 3)

Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.

Outcome measures

Outcome measures
Measure	qHPV Vaccine in Base Study n=911 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 24 Postdose 3 of qHPV Vaccine (Month 30) Type 6: n=799	146.5 milliMerck units/mL Interval 135.6 to 158.2	—
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 24 Postdose 3 of qHPV Vaccine (Month 30) Type 11: n=800	177.0 milliMerck units/mL Interval 163.6 to 191.5	—
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 24 Postdose 3 of qHPV Vaccine (Month 30) Type 16: n=795	826.1 milliMerck units/mL Interval 757.8 to 900.5	—
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 24 Postdose 3 of qHPV Vaccine (Month 30) Type 18: n=803	114.7 milliMerck units/mL Interval 102.8 to 127.9	—

SECONDARY outcome

Timeframe: Month 37 (31 Months Post-dose 3)

Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.

Outcome measures

Outcome measures
Measure	qHPV Vaccine in Base Study n=772 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 31 Postdose 3 of qHPV Vaccine (Month 37) Type 18: n=660	102.4 milliMerck units/mL Interval 90.9 to 115.3	—
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 31 Postdose 3 of qHPV Vaccine (Month 37) Type 6: n=657	128.6 milliMerck units/mL Interval 118.2 to 139.9	—
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 31 Postdose 3 of qHPV Vaccine (Month 37) Type 11: n=657	149.7 milliMerck units/mL Interval 137.0 to 163.6	—
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 31 Postdose 3 of qHPV Vaccine (Month 37) Type 16: n=655	680.4 milliMerck units/mL Interval 617.2 to 750.1	—

SECONDARY outcome

Timeframe: Month 37 (1 Month Post-dose 3 of qHPV)

Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations within appropriate day ranges, were seronegative to the respective HPV type at Month 30, and had a valid serology result at the specified time for assessment.

Outcome measures

Outcome measures
Measure	qHPV Vaccine in Base Study n=440 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
Geometric Mean Titers in the Extension Group for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37) Type 6: n=246	768.6 milliMerck units/mL Interval 676.6 to 873.0	—
Geometric Mean Titers in the Extension Group for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37) Type 11: n=246	1041.0 milliMerck units/mL Interval 919.8 to 1178.2	—
Geometric Mean Titers in the Extension Group for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37) Type 16: n=246	4312.7 milliMerck units/mL Interval 3715.6 to 5005.7	—
Geometric Mean Titers in the Extension Group for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37) Type 18: n=255	830.1 milliMerck units/mL Interval 714.0 to 965.1	—

SECONDARY outcome

Timeframe: Up to Month 126

Population: Per-Protocol Effectiveness population: male participants without protocol violations who received at least 1 dose of qHPV vaccine and at least 1 effectiveness follow-up visit.

The HPV types were determined by polymerase chain reaction (PCR) testing. The combined incidence of HPV 6/11/16/18-related persistent infection and HPV 6/11/16/18-related cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ (AIS), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), genital warts, and cervical/Vaginal/vulvar cancer was assessed in female participants.

Outcome measures

Outcome measures
Measure	qHPV Vaccine in Base Study n=259 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study n=96 Participants Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related CIN, AIS, VIN, VaIN, Genital Warts, and Cervical/Vaginal/Vulvar Cancer in Females	0.2 Cases per 100 person-years at risk Interval 0.1 to 0.7	0.2 Cases per 100 person-years at risk Interval 0.0 to 1.4

SECONDARY outcome

Timeframe: Up to Month 126

Population: Per-Protocol Effectiveness population: male participants without protocol violations who received at least 1 dose of qHPV vaccine and at least 1 effectiveness follow-up visit.

The HPV types were determined by PCR testing. Combined incidence of HPV 6/11/16/18-related persistent infection and HPV 6/11/16/18-related penile/perineal/perianal intraepithelial neoplasia (PIN), genital warts, and penile/perineal/perianal cancer was assessed in male participants.

Outcome measures

Outcome measures
Measure	qHPV Vaccine in Base Study n=179 Participants Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6	Placebo in Base Study n=62 Participants Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related PIN, Genital Warts, and Penile/Perineal/Perianal Cancer in Males	0.6 Cases per 100 person-years at risk Interval 0.2 to 1.5	0.3 Cases per 100 person-years at risk Interval 0.0 to 1.9

Adverse Events

qHPV Vaccine in Base: Vaccine Phase and Follow-up

Serious events: 6 serious events

Other events: 918 other events

Deaths: 0 deaths

Placebo in Base: Vaccine Phase and Follow-up

Serious events: 0 serious events

Other events: 344 other events

Deaths: 0 deaths

qHPV Vaccine in Base: Extension and Long-term Follow-up

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

qHPV Vaccine in Extension: Extension and Long-term Follow-up

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	qHPV Vaccine in Base: Vaccine Phase and Follow-up n=1165 participants at risk Participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of qHPV at Day 1, Month 2, and Month 6, and had safety follow-up. Adverse events are reported for this group from Day 1 to Month 30.	Placebo in Base: Vaccine Phase and Follow-up n=584 participants at risk Participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo vaccine at Day 1, Month 2, and Month 6, and had safety followup. Adverse events are reported for this group from Day 1 to Month 30.	qHPV Vaccine in Base: Extension and Long-term Follow-up n=932 participants at risk Participants who received qHPV in the Base Study. No study treatment was administered after Month 6 for these participants. Adverse events are reported for this group from Month 30 to Month 126. Non-serious AEs were not solicited.	qHPV Vaccine in Extension: Extension and Long-term Follow-up n=481 participants at risk Participants who received placebo in the Base Study and three 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36 in the Extension Study. Adverse events are reported for this group from Month 30 to Month 126. Non-serious AEs were not solicited.
Renal and urinary disorders Acute kidney injury	0.09% 1/1165 • Number of events 1 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/584 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/932 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/481 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.
Infections and infestations Appendicitis	0.09% 1/1165 • Number of events 1 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/584 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/932 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/481 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.
Gastrointestinal disorders Colitis ulcerative	0.09% 1/1165 • Number of events 1 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/584 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/932 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/481 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.
Infections and infestations Localised infection	0.09% 1/1165 • Number of events 1 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/584 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/932 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/481 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.
Musculoskeletal and connective tissue disorders Pain in extremity	0.09% 1/1165 • Number of events 1 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/584 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/932 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/481 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.
Reproductive system and breast disorders Dysfunctional uterine bleeding	0.09% 1/1165 • Number of events 1 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/584 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/932 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/481 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.09% 1/1165 • Number of events 1 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/584 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/932 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/481 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.09% 1/1165 • Number of events 1 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/584 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/932 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/481 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.
Nervous system disorders VIIth nerve paralysis	0.00% 0/1165 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/584 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/932 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.21% 1/481 • Number of events 1 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.
General disorders Chest pain	0.00% 0/1165 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/584 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/932 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.21% 1/481 • Number of events 1 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/1165 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/584 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/932 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.21% 1/481 • Number of events 1 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/1165 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/584 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.11% 1/932 • Number of events 1 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/481 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.
Nervous system disorders Tonic clonic movements	0.00% 0/1165 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/584 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.11% 1/932 • Number of events 1 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/481 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.

Other adverse events

Other adverse events
Measure	qHPV Vaccine in Base: Vaccine Phase and Follow-up n=1165 participants at risk Participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of qHPV at Day 1, Month 2, and Month 6, and had safety follow-up. Adverse events are reported for this group from Day 1 to Month 30.	Placebo in Base: Vaccine Phase and Follow-up n=584 participants at risk Participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo vaccine at Day 1, Month 2, and Month 6, and had safety followup. Adverse events are reported for this group from Day 1 to Month 30.	qHPV Vaccine in Base: Extension and Long-term Follow-up n=932 participants at risk Participants who received qHPV in the Base Study. No study treatment was administered after Month 6 for these participants. Adverse events are reported for this group from Month 30 to Month 126. Non-serious AEs were not solicited.	qHPV Vaccine in Extension: Extension and Long-term Follow-up n=481 participants at risk Participants who received placebo in the Base Study and three 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36 in the Extension Study. Adverse events are reported for this group from Month 30 to Month 126. Non-serious AEs were not solicited.
General disorders Injection site erythema	20.3% 237/1165 • Number of events 323 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	13.4% 78/584 • Number of events 109 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/932 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.21% 1/481 • Number of events 1 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.
General disorders Injection site pain	73.2% 853/1165 • Number of events 1705 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	45.9% 268/584 • Number of events 434 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/932 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.62% 3/481 • Number of events 3 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.
General disorders Injection site swelling	20.7% 241/1165 • Number of events 336 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	7.7% 45/584 • Number of events 63 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/932 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.21% 1/481 • Number of events 1 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.
General disorders Pyrexia	8.6% 100/1165 • Number of events 114 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	7.5% 44/584 • Number of events 60 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/932 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/481 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.
Nervous system disorders Headache	19.0% 221/1165 • Number of events 297 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	19.0% 111/584 • Number of events 163 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/932 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/481 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.5% 52/1165 • Number of events 56 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	4.1% 24/584 • Number of events 26 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/932 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.	0.00% 0/481 • Day 1 to Month 30 and Month 30 to Month 126 Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER