Trial Outcomes & Findings for A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019) (NCT NCT00090220)

Last Updated: 2017-04-21

Results Overview

The four HPV types were determined by polymerase chain reaction (PCR) testing. VIN = vulvar intraepithelial neoplasia; VaIN = vaginal intraepithelial neoplasia; AIS = adenocarcinoma in situ.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

3819 participants

Primary outcome timeframe

Up to 48 months (4 years) after the first dose of qHPV vaccine in the Base Study

Results posted on

2017-04-21

Participant Flow

Base Study Vaccination Period covers Day 1 to Month 7; Base Study Follow-up Period covers Month 7 up to approximately Month 48; Extension 1 (EXT1) Period covers approximately Month 60 to Month 67; Long-term Follow-up (LTFU, EXT2) covers approximately Month 72 up to Month 120

Participant milestones

Participant milestones
Measure	qHPV Vaccine in Base Study Participants received Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (qHPV, Gardasil) at Day 1, Month 2, and Month 6	Placebo in Base Study Participants received placebo at Day 1, Month 2, and Month 6	Placebo in Base Study: EXT1 Participants who received placebo in the Base Study were offered open-label qHPV vaccine at EXT1 Day 1 (approximately 60 months after Day 1 of the Base Study), Month 2, and Month 6 and were followed to EXT1 Month 7 (approximately 67 months after Day 1 of the Base Study)	Incomplete qHPV Regimen in Base Study: EXT1 Participants who received an incomplete regimen of qHPV in the Base Study were offered open-label qHPV vaccine beginning at EXT1 Day 1 (approximately 60 months after Day 1 of the Base Study) and were followed to EXT1 Month 7 (approximately 67 months after Day 1 of the Base Study)	qHPV Vaccine in Base Study: LTFU (EXT2) Participants at sites in Colombia who received qHPV vaccination in the Base Study were followed from approximately Month 72 up to Month 120 (Year 10) after Day 1 in the Base Study	Placebo in Base Study and qHPV Vaccine in EXT1: LTFU (EXT2) Participants at sites in Colombia who received placebo or an incomplete regimen of qHPV in the Base Study and open-label qHPV in EXT1 were followed from approximately Month 72 up to Month 120 (Year 10) after Day 1 in the Base Study.
Base Study Vaccination Period STARTED	1911	1908	0	0	0	0
Base Study Vaccination Period Vaccinated	1910	1907	0	0	0	0
Base Study Vaccination Period COMPLETED	1847	1845	0	0	0	0
Base Study Vaccination Period NOT COMPLETED	64	63	0	0	0	0
Base Study Follow-up Period STARTED	1855	1851	0	0	0	0
Base Study Follow-up Period COMPLETED	1695	1687	0	0	0	0
Base Study Follow-up Period NOT COMPLETED	160	164	0	0	0	0
Extension 1 (EXT1) STARTED	0	0	1322	7	0	0
Extension 1 (EXT1) Vaccinated	0	0	1321	7	0	0
Extension 1 (EXT1) COMPLETED	0	0	1267	5	0	0
Extension 1 (EXT1) NOT COMPLETED	0	0	55	2	0	0
Long-term Follow-up (EXT2) STARTED	0	0	0	0	685	651
Long-term Follow-up (EXT2) COMPLETED	0	0	0	0	641	623
Long-term Follow-up (EXT2) NOT COMPLETED	0	0	0	0	44	28

Reasons for withdrawal

Reasons for withdrawal
Measure	qHPV Vaccine in Base Study Participants received Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (qHPV, Gardasil) at Day 1, Month 2, and Month 6	Placebo in Base Study Participants received placebo at Day 1, Month 2, and Month 6	Placebo in Base Study: EXT1 Participants who received placebo in the Base Study were offered open-label qHPV vaccine at EXT1 Day 1 (approximately 60 months after Day 1 of the Base Study), Month 2, and Month 6 and were followed to EXT1 Month 7 (approximately 67 months after Day 1 of the Base Study)	Incomplete qHPV Regimen in Base Study: EXT1 Participants who received an incomplete regimen of qHPV in the Base Study were offered open-label qHPV vaccine beginning at EXT1 Day 1 (approximately 60 months after Day 1 of the Base Study) and were followed to EXT1 Month 7 (approximately 67 months after Day 1 of the Base Study)	qHPV Vaccine in Base Study: LTFU (EXT2) Participants at sites in Colombia who received qHPV vaccination in the Base Study were followed from approximately Month 72 up to Month 120 (Year 10) after Day 1 in the Base Study	Placebo in Base Study and qHPV Vaccine in EXT1: LTFU (EXT2) Participants at sites in Colombia who received placebo or an incomplete regimen of qHPV in the Base Study and open-label qHPV in EXT1 were followed from approximately Month 72 up to Month 120 (Year 10) after Day 1 in the Base Study.
Base Study Vaccination Period Randomized not Vaccinated	1	1	0	0	0	0
Base Study Vaccination Period Adverse Event	6	1	0	0	0	0
Base Study Vaccination Period Lost to Follow-up	24	28	0	0	0	0
Base Study Vaccination Period Withdrawal by Subject	23	27	0	0	0	0
Base Study Vaccination Period Patient Moved	6	2	0	0	0	0
Base Study Vaccination Period Other	4	4	0	0	0	0
Base Study Follow-up Period Adverse Event	6	1	0	0	0	0
Base Study Follow-up Period Lost to Follow-up	88	78	0	0	0	0
Base Study Follow-up Period Withdrawal by Subject	27	36	0	0	0	0
Base Study Follow-up Period Patient Moved	20	28	0	0	0	0
Base Study Follow-up Period Other	19	21	0	0	0	0
Extension 1 (EXT1) Adverse Event	0	0	4	0	0	0
Extension 1 (EXT1) Lost to Follow-up	0	0	22	0	0	0
Extension 1 (EXT1) Moved	0	0	2	1	0	0
Extension 1 (EXT1) Withdrawal by Subject	0	0	25	0	0	0
Extension 1 (EXT1) Protocol Violation	0	0	0	1	0	0
Extension 1 (EXT1) Other reason	0	0	2	0	0	0
Long-term Follow-up (EXT2) Lost to Follow-up	0	0	0	0	38	23
Long-term Follow-up (EXT2) Death	0	0	0	0	1	1
Long-term Follow-up (EXT2) Withdrawal by Subject	0	0	0	0	4	4
Long-term Follow-up (EXT2) Other	0	0	0	0	1	0

Baseline Characteristics

A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	qHPV Vaccine in Base Study n=1911 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=1908 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	Total n=3819 Participants Total of all reporting groups
Age, Continuous	35 Years n=5 Participants	34 Years n=7 Participants	34 Years n=5 Participants
Sex: Female, Male Female	1911 Participants n=5 Participants	1908 Participants n=7 Participants	3819 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	596 participants n=5 Participants	596 participants n=7 Participants	1192 participants n=5 Participants
Race/Ethnicity, Customized Black	100 participants n=5 Participants	82 participants n=7 Participants	182 participants n=5 Participants
Race/Ethnicity, Customized Hispanic American	822 participants n=5 Participants	827 participants n=7 Participants	1649 participants n=5 Participants
Race/Ethnicity, Customized Native American	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized White	388 participants n=5 Participants	397 participants n=7 Participants	785 participants n=5 Participants
Race/Ethnicity, Customized Multi-Racial	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants
Race/Ethnicity, Customized Polynesian	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 48 months (4 years) after the first dose of qHPV vaccine in the Base Study

Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the relevant HPV type at Day 1 and PCR negative to the relevant HPV type Day 1 through Month 7, and provided follow-up data after Month 7

The four HPV types were determined by polymerase chain reaction (PCR) testing. VIN = vulvar intraepithelial neoplasia; VaIN = vaginal intraepithelial neoplasia; AIS = adenocarcinoma in situ.

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1601 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=1599 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Incidence Rate of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer	0.2 Incidence per 100 person-years	1.7 Incidence per 100 person-years	—

PRIMARY outcome

Timeframe: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)

Population: Participants who received \>=1 qHPV vaccination or placebo injection in the Base Study and had safety follow-up

An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose. Vaccine-related SAEs are those deemed by the investigator to be definitely, probably, or possibly related to study vaccine.

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1890 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=1888 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120

Population: Participants who received \>=1 qHPV vaccination in the Base Study or EXT1 and had safety follow-up

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1890 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=1327 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Number of Participants With Vaccine-Related SAEs After Vaccine Administration	0 Participants	1 Participants	—

PRIMARY outcome

Timeframe: qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120

Population: Participants who received \>=1 qHPV vaccination in the Base Study or EXT1 and had safety follow-up

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1890 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=1327 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Number of Participants With an SAE Resulting in Death After Vaccine Administration	8 Participants	4 Participants	—

PRIMARY outcome

Timeframe: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)

The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Day 1 to Year 4, conditional on having been event-free at Day 1.

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1602 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=1599 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Cumulative Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN) or Condyloma: Day 1 to Year 4	0.0006 Cumulative Incidence Probability Interval 0.0001 to 0.0045	0.0124 Cumulative Incidence Probability Interval 0.0079 to 0.0195	—

PRIMARY outcome

Timeframe: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study

Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.

The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 4 to Year 8, conditional on having been event-free from Day 1 to Year 4. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=927 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 4 to 8	0.0000 Cumulative Incidence Probability Interval 0.0 to 0.0	—	—

PRIMARY outcome

Timeframe: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study

Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.

The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10, conditional on having been event-free from Day 1 to Year 6.

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=599 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 6 to 10	0.0000 Cumulative Incidence Probability Interval 0.0 to 0.0	—	—

PRIMARY outcome

Timeframe: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)

The four HPV types were determined by PCR testing.

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1602 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=1599 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Day 1 to Year 4	0.0 Incidence per 100 person-years Interval 0.0 to 0.1	0.4 Incidence per 100 person-years Interval 0.2 to 0.6	—

PRIMARY outcome

Timeframe: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study

The four HPV types were determined by PCR testing. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=927 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 4 to 8	0.0 Incidence per 100 person-years Interval 0.0 to 0.2	—	—

PRIMARY outcome

Timeframe: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study

Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.

The four HPV types were determined by PCR testing.

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=599 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 6 to 10	0.0 Incidence per 100 person-years Interval 0.0 to 0.2	—	—

PRIMARY outcome

Timeframe: Month 7 (1 month after the third dose of qHPV vaccine in the Base Study)

Population: Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.

Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1910 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=953 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old n=957 Participants 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study HPV Type 6: n=1249, 605, 644	416.2 mMU/mL Interval 391.9 to 442.0	437.4 mMU/mL Interval 401.2 to 476.8	397.3 mMU/mL Interval 365.4 to 431.9
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study HPV Type 11: n=1249, 605, 644	551.2 mMU/mL Interval 520.5 to 583.6	595.1 mMU/mL Interval 548.3 to 646.0	512.8 mMU/mL Interval 473.6 to 555.2
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study HPV Type 16: n=1269, 612, 657	2225.9 mMU/mL Interval 2101.2 to 2358.0	2334.2 mMU/mL Interval 2148.4 to 2536.1	2129.5 mMU/mL Interval 1965.7 to 2307.1
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study HPV Type 18: n=1430, 708, 722	356.9 mMU/mL Interval 335.8 to 379.4	393.1 mMU/mL Interval 360.6 to 428.7	324.6 mMU/mL Interval 298.0 to 353.6

PRIMARY outcome

Timeframe: Month 12 (6 months after the third dose of qHPV vaccine in the Base Study)

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1910 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=953 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old n=957 Participants 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study HPV Type 16: n=1236, 588, 648	719.6 mMU/mL Interval 684.0 to 757.0	743.4 mMU/mL Interval 690.8 to 800.1	698.6 mMU/mL Interval 651.3 to 749.2
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study HPV Type 18: n=1387, 678, 709	79.2 mMU/mL Interval 74.3 to 84.5	84.2 mMU/mL Interval 76.9 to 92.3	74.7 mMU/mL Interval 68.3 to 81.7
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study HPV Type 6: n=1225, 589, 636	155.1 mMU/mL Interval 147.8 to 162.8	157.3 mMU/mL Interval 146.7 to 168.6	153.2 mMU/mL Interval 143.3 to 163.8
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study HPV Type 11: n=1225, 589, 636	176.9 mMU/mL Interval 168.2 to 186.1	184.5 mMU/mL Interval 171.5 to 198.4	170.2 mMU/mL Interval 158.6 to 182.5

PRIMARY outcome

Timeframe: Month 24 (18 months after the third dose of qHPV vaccine in the Base Study)

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1910 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=953 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old n=957 Participants 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study HPV Type 6: n=1207, 579, 628	70.3 mMU/mL Interval 66.2 to 74.6	71.3 mMU/mL Interval 65.4 to 77.8	69.3 mMU/mL Interval 63.8 to 75.3
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study HPV Type 18: n=1378, 673, 705	28.3 mMU/mL Interval 26.3 to 30.5	31.0 mMU/mL Interval 27.9 to 34.4	26.0 mMU/mL Interval 23.5 to 28.8
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study HPV Type 11: n=1207, 579, 628	77.6 mMU/mL Interval 73.1 to 82.5	82.5 mMU/mL Interval 75.6 to 90.0	73.4 mMU/mL Interval 67.5 to 79.8
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study HPV Type 16: n=1225, 583, 642	278.9 mMU/mL Interval 260.7 to 298.3	287.3 mMU/mL Interval 260.6 to 316.9	271.4 mMU/mL Interval 247.2 to 297.9

PRIMARY outcome

Timeframe: Month 36 (30 months after the third dose of qHPV vaccine in the Base Study)

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1910 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=953 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old n=957 Participants 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study HPV Type 6: n=1169, 551, 618	80.8 mMU/mL Interval 76.4 to 85.5	80.5 mMU/mL Interval 74.2 to 87.4	81.1 mMU/mL Interval 75.1 to 87.7
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study HPV Type 11: n=1169, 551, 618	81.0 mMU/mL Interval 76.6 to 85.6	85.3 mMU/mL Interval 78.6 to 92.5	77.4 mMU/mL Interval 71.7 to 83.5
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study HPV Type 16: n=1190, 559, 631	285.7 mMU/mL Interval 269.0 to 303.4	296.2 mMU/mL Interval 271.2 to 323.4	276.7 mMU/mL Interval 254.7 to 300.5
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study HPV Type 18: n=1331, 642, 689	29.4 mMU/mL Interval 27.4 to 31.6	32.2 mMU/mL Interval 29.1 to 35.7	27.0 mMU/mL Interval 24.5 to 29.8

PRIMARY outcome

Timeframe: Month 48 (42 months after the third dose of qHPV vaccine in the Base Study)

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1910 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=953 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old n=957 Participants 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study HPV Type 18: n=1313, 625, 688	23.1 mMU/mL Interval 21.5 to 24.8	25.3 mMU/mL Interval 22.8 to 28.1	21.2 mMU/mL Interval 19.2 to 23.4
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study HPV Type 6: n=1152, 536, 616	60.9 mMU/mL Interval 57.3 to 64.7	59.6 mMU/mL Interval 54.5 to 65.2	62.0 mMU/mL Interval 57.1 to 67.4
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study HPV Type 11: n=1152, 536, 616	65.9 mMU/mL Interval 62.1 to 69.9	69.7 mMU/mL Interval 63.9 to 76.0	62.7 mMU/mL Interval 57.8 to 68.0
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study HPV Type 16: n=1172, 544, 628	202.1 mMU/mL Interval 189.5 to 215.5	213.4 mMU/mL Interval 194.1 to 234.5	192.8 mMU/mL Interval 176.5 to 210.5

PRIMARY outcome

Timeframe: Month 72 (66 months after the third dose of qHPV vaccine in the Base Study)

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1910 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=953 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old n=957 Participants 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study HPV Type 6: n=468, 198, 270	64.3 mMU/mL Interval 58.4 to 70.7	60.7 mMU/mL Interval 52.5 to 70.3	67.0 mMU/mL Interval 59.1 to 75.9
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study HPV Type 18: n=530, 237, 293	20.9 mMU/mL Interval 18.8 to 23.4	22.8 mMU/mL Interval 19.4 to 26.9	19.5 mMU/mL Interval 16.8 to 22.6
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study HPV Type 11: n=466, 196, 270	64.3 mMU/mL Interval 58.6 to 70.5	68.9 mMU/mL Interval 59.7 to 79.5	61.1 mMU/mL Interval 54.1 to 69.0
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study HPV Type 16: n=473, 197, 276	219.5 mMU/mL Interval 198.3 to 242.9	220.3 mMU/mL Interval 188.2 to 257.8	218.9 mMU/mL Interval 191.6 to 250.0

PRIMARY outcome

Timeframe: Month 96 (90 months after the third dose of qHPV vaccine in the Base Study)

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1910 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=953 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old n=957 Participants 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study HPV Type 6: n=459, 193, 266	56.7 mMU/mL Interval 51.4 to 62.6	56.1 mMU/mL Interval 48.2 to 65.3	57.2 mMU/mL Interval 50.2 to 65.1
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study HPV Type 11: n=459, 193, 266	45.9 mMU/mL Interval 41.7 to 50.6	49.6 mMU/mL Interval 42.8 to 57.5	43.5 mMU/mL Interval 38.3 to 49.3
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study HPV Type 16: n=464, 192, 272	168.3 mMU/mL Interval 151.3 to 187.3	174.1 mMU/mL Interval 147.4 to 205.6	164.4 mMU/mL Interval 142.9 to 189.0
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study HPV Type 18: n=519, 230, 289	18.3 mMU/mL Interval 16.5 to 20.4	19.1 mMU/mL Interval 16.3 to 22.4	17.7 mMU/mL Interval 15.4 to 20.4

PRIMARY outcome

Timeframe: Month 120 (114 months after the third dose of qHPV vaccine in the Base Study)

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1910 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=953 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old n=957 Participants 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study HPV Type 16: n=443, 179, 264	140.9 mMU/mL Interval 125.9 to 157.7	147.0 mMU/mL Interval 123.2 to 175.5	136.9 mMU/mL Interval 118.3 to 158.4
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study HPV Type 18: n=498, 216, 282	16.0 mMU/mL Interval 14.3 to 17.8	16.6 mMU/mL Interval 14.1 to 19.6	15.5 mMU/mL Interval 13.4 to 17.9
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study HPV Type 6: n=441, 181, 260	46.9 mMU/mL Interval 42.2 to 52.0	45.7 mMU/mL Interval 38.9 to 53.8	47.7 mMU/mL Interval 41.6 to 54.6
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study HPV Type 11: n=441, 181, 260	42.3 mMU/mL Interval 38.2 to 46.9	45.2 mMU/mL Interval 38.6 to 53.0	40.4 mMU/mL Interval 35.4 to 46.2

PRIMARY outcome

Timeframe: Month 7 (1 month after the third dose of qHPV vaccine in the Base Study)

Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were \>20 for Type 6, \>16 for Type 11, \>20 for Type 16, and \>24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1910 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=953 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old n=957 Participants 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study HPV Type 6: n=1249, 605, 644	98.4 Percentage of participants Interval 97.5 to 99.0	98.7 Percentage of participants Interval 97.4 to 99.4	98.1 Percentage of participants Interval 96.8 to 99.0
Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study HPV Type 11: n=1249, 605, 644	98.1 Percentage of participants Interval 97.2 to 98.8	98.5 Percentage of participants Interval 97.2 to 99.3	97.7 Percentage of participants Interval 96.2 to 98.7
Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study HPV Type 16: n=1269, 612, 657	98.8 Percentage of participants Interval 98.1 to 99.3	99.5 Percentage of participants Interval 98.6 to 99.9	98.2 Percentage of participants Interval 96.8 to 99.1
Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study HPV Type 18: n=1430, 708, 722	97.3 Percentage of participants Interval 96.4 to 98.1	98.3 Percentage of participants Interval 97.1 to 99.1	96.4 Percentage of participants Interval 94.8 to 97.6

PRIMARY outcome

Timeframe: Month 12 (6 months after the third dose of qHPV vaccine in the Base Study)

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1910 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=953 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old n=957 Participants 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study HPV Type 6: n=1225, 589, 636	98.7 Percentage of participants Interval 97.9 to 99.3	98.6 Percentage of participants Interval 97.3 to 99.4	98.7 Percentage of participants Interval 97.5 to 99.5
Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study HPV Type 11: n=1225, 589, 636	98.8 Percentage of participants Interval 98.0 to 99.3	99.3 Percentage of participants Interval 98.3 to 99.8	98.3 Percentage of participants Interval 96.9 to 99.1
Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study HPV Type 16: n=1236, 588, 648	99.7 Percentage of participants Interval 99.2 to 99.9	99.8 Percentage of participants Interval 99.1 to 100.0	99.5 Percentage of participants Interval 98.7 to 99.9
Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study HPV Type 18: n=1387, 678, 709	84.6 Percentage of participants Interval 82.6 to 86.5	86.1 Percentage of participants Interval 83.3 to 88.6	83.2 Percentage of participants Interval 80.3 to 85.9

PRIMARY outcome

Timeframe: Month 24 (18 months after the third dose of qHPV vaccine in the Base Study)

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1910 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=953 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old n=957 Participants 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study HPV Type 11: n=1207, 579, 628	92.4 Percentage of participants Interval 90.7 to 93.8	94.0 Percentage of participants Interval 91.7 to 95.8	90.9 Percentage of participants Interval 88.4 to 93.1
Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study HPV Type 16: n=1225, 583, 642	96.5 Percentage of participants Interval 95.3 to 97.4	96.9 Percentage of participants Interval 95.2 to 98.2	96.1 Percentage of participants Interval 94.3 to 97.5
Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study HPV Type 18: n=1378, 673, 705	54.6 Percentage of participants Interval 52.0 to 57.3	57.4 Percentage of participants Interval 53.5 to 61.1	52.1 Percentage of participants Interval 48.3 to 55.8
Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study HPV Type 6: n=1207, 579, 628	89.3 Percentage of participants Interval 87.4 to 91.0	89.5 Percentage of participants Interval 86.7 to 91.8	89.2 Percentage of participants Interval 86.5 to 91.5

PRIMARY outcome

Timeframe: Month 36 (30 months after the third dose of qHPV vaccine in the Base Study)

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1910 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=953 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old n=957 Participants 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study HPV Type 6: n=1169, 551, 618	91.5 Percentage of participants Interval 89.8 to 93.1	92.0 Percentage of participants Interval 89.4 to 94.1	91.1 Percentage of participants Interval 88.6 to 93.2
Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study HPV Type 11: n=1169, 551, 618	95.5 Percentage of participants Interval 94.1 to 96.6	96.7 Percentage of participants Interval 94.9 to 98.1	94.3 Percentage of participants Interval 92.2 to 96.0
Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study HPV Type 16: n=1190, 559, 631	98.7 Percentage of participants Interval 97.9 to 99.3	99.1 Percentage of participants Interval 97.9 to 99.7	98.4 Percentage of participants Interval 97.1 to 99.2
Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study HPV Type 18: n=1331, 642, 689	55.5 Percentage of participants Interval 52.8 to 58.2	58.7 Percentage of participants Interval 54.8 to 62.6	52.5 Percentage of participants Interval 48.7 to 56.3

PRIMARY outcome

Timeframe: Month 48 (42 months after the third dose of qHPV vaccine in the Base Study)

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1910 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=953 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old n=957 Participants 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study HPV Type 6: n=1152, 536, 616	85.6 Percentage of participants Interval 83.4 to 87.6	86.2 Percentage of participants Interval 83.0 to 89.0	85.1 Percentage of participants Interval 82.0 to 87.8
Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study HPV Type 11: n=1152, 536, 616	92.0 Percentage of participants Interval 90.3 to 93.5	93.8 Percentage of participants Interval 91.5 to 95.7	90.4 Percentage of participants Interval 87.8 to 92.6
Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study HPV Type 16: n=1172, 544, 628	97.4 Percentage of participants Interval 96.3 to 98.2	97.8 Percentage of participants Interval 96.2 to 98.9	97.0 Percentage of participants Interval 95.3 to 98.2
Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study HPV Type 18: n=1313, 625, 688	47.9 Percentage of participants Interval 45.2 to 50.6	50.7 Percentage of participants Interval 46.7 to 54.7	45.3 Percentage of participants Interval 41.6 to 49.2

PRIMARY outcome

Timeframe: Month 72 (66 months after the third dose of qHPV vaccine in the Base Study)

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1910 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=953 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old n=957 Participants 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study HPV Type 6: n=468, 198, 270	89.1 Percentage of participants Interval 85.9 to 91.8	89.4 Percentage of participants Interval 84.2 to 93.3	88.9 Percentage of participants Interval 84.5 to 92.4
Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study HPV Type 11: n=466, 196, 270	92.1 Percentage of participants Interval 89.2 to 94.3	94.4 Percentage of participants Interval 90.2 to 97.2	90.4 Percentage of participants Interval 86.2 to 93.6
Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study HPV Type 16: n=473, 197, 276	97.3 Percentage of participants Interval 95.3 to 98.5	97.5 Percentage of participants Interval 94.2 to 99.2	97.1 Percentage of participants Interval 94.4 to 98.7
Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study HPV Type 18: n=530, 237, 293	45.3 Percentage of participants Interval 41.0 to 49.6	48.5 Percentage of participants Interval 42.0 to 55.1	42.7 Percentage of participants Interval 36.9 to 48.5

PRIMARY outcome

Timeframe: Month 96 (96 months after the third dose of qHPV vaccine in the Base Study)

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1910 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=953 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old n=957 Participants 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study HPV Type 6: n=459, 193, 266	84.7 Percentage of participants Interval 81.1 to 87.9	85.0 Percentage of participants Interval 79.1 to 89.7	84.6 Percentage of participants Interval 79.7 to 88.7
Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study HPV Type 11: n=459, 193, 266	85.0 Percentage of participants Interval 81.4 to 88.1	90.7 Percentage of participants Interval 85.7 to 94.4	80.8 Percentage of participants Interval 75.6 to 85.4
Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study HPV Type 16: n=464, 192, 272	95.5 Percentage of participants Interval 93.2 to 97.2	95.8 Percentage of participants Interval 92.0 to 98.2	95.2 Percentage of participants Interval 92.0 to 97.4
Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study HPV Type 18: n=519, 230, 289	40.1 Percentage of participants Interval 35.8 to 44.4	41.3 Percentage of participants Interval 34.9 to 48.0	39.1 Percentage of participants Interval 33.4 to 45.0

PRIMARY outcome

Timeframe: Month 120 (114 months after the third dose of qHPV vaccine in the Base Study)

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1910 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=953 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old n=957 Participants 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study HPV Type 6: n=441, 181, 260	78.7 Percentage of participants Interval 74.6 to 82.4	79.0 Percentage of participants Interval 72.3 to 84.7	78.5 Percentage of participants Interval 73.0 to 83.3
Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study HPV Type 11: n=441, 181, 260	85.0 Percentage of participants Interval 81.4 to 88.2	86.7 Percentage of participants Interval 80.9 to 91.3	83.8 Percentage of participants Interval 78.8 to 88.1
Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study HPV Type 16: n=443, 179, 264	93.9 Percentage of participants Interval 91.3 to 95.9	95.0 Percentage of participants Interval 90.7 to 97.7	93.2 Percentage of participants Interval 89.4 to 95.9
Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study HPV Type 18: n=498, 216, 282	35.9 Percentage of participants Interval 31.7 to 40.3	38.9 Percentage of participants Interval 32.3 to 45.7	33.7 Percentage of participants Interval 28.2 to 39.5

SECONDARY outcome

Timeframe: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)

HPV 6/11: The two types of HPV (types 6/11) were determined by PCR testing

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1316 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=1316 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Incidence Rate of HPV 6/11 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer	0.0 Incidence per 100 person-years	0.9 Incidence per 100 person-years	—

SECONDARY outcome

Timeframe: Up to 48 months (4 years) after the first dose of qHPV vaccine or placebo in the Base Study

The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Day 1 to Year 4 conditional on having been event-free at Day 1.

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1316 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=1316 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Cumulative Incidence of HPV 6/11-related Condyloma: Day 1 to Year 4	0.0000 Cumulative Incidence Probability Interval 0.0 to 0.0	0.0055 Cumulative Incidence Probability Interval 0.0026 to 0.0115	—

SECONDARY outcome

Timeframe: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study

The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 4 to Year 8 conditional on having been event-free from Day 1 to Year 4. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=751 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Cumulative Incidence of HPV 6/11-related Condyloma: Year 4 to Year 8	0.0000 Cumulative Incidence Probability Interval 0.0 to 0.0	—	—

SECONDARY outcome

Timeframe: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study

Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.

The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10 conditional on having been event-free from Day 1 to Year 6.

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=492 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Cumulative Incidence of HPV 6/11-related Condyloma: Year 6 to Year 10	0.0000 Cumulative Incidence Probability Interval 0.0 to 0.0	—	—

SECONDARY outcome

Timeframe: Up to 48 months (4 years) after the first dose of qHPV vaccine or placebo in the Base Study

The four HPV types were determined by PCR testing.

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1316 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=1316 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Day 1 to Year 4	0.0 Incidence per 100 person-years Interval 0.0 to 0.1	0.2 Incidence per 100 person-years Interval 0.1 to 0.3	—

SECONDARY outcome

Timeframe: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=751 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Year 4 to Year 8	0.0 Incidence per 100 person-years Interval 0.0 to 0.2	—	—

SECONDARY outcome

Timeframe: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study

Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=492 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Year 6 to Year 10	0.0 Incidence per 100 person-years Interval 0.0 to 0.2	—	—

SECONDARY outcome

Timeframe: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)

This outcome measure was not analyzed because of diminished interest by experts in composite efficacy endpoints associated with these HPV types

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)

HPV 16/18: The two types of HPV (types 16/18) were determined by PCR testing

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1587 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=1571 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Incidence Rate of HPV 16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer	0.2 Incidence per 100 person-years	1.0 Incidence per 100 person-years	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1570 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=1558 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Day 1 to Year 4	0.0007 Cumulative Incidence Probability Interval 0.0001 to 0.0046	0.0041 Cumulative Incidence Probability Interval 0.0019 to 0.0092	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=842 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Year 4 to 8	0.0000 Cumulative Incidence Probability Interval 0.0 to 0.0	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study

Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=541 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Year 6 to 10	0.0000 Cumulative Incidence Probability Interval 0.0 to 0.0	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)

The four HPV types were determined by PCR testing.

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=1570 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study n=1558 Participants Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Day 1 to Year 4	0.0 Incidence per 100 person-years Interval 0.0 to 0.1	0.1 Incidence per 100 person-years Interval 0.0 to 0.3	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=842 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Year 4 to 8	0.0 Incidence per 100 person-years Interval 0.0 to 0.2	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study

Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.

The four HPV types were determined by PCR testing.

Outcome measures

Outcome measures
Measure	qHPV in Base Study n=541 Participants Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study	Placebo in Base Study Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study	qHPV in Base Study: Participants 35 to 45 Years Old 35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Year 6 to 10	0.0 Incidence per 100 person-years Interval 0.0 to 0.2	—	—

Adverse Events

qHPV Vaccine: Base Study

Serious events: 15 serious events

Other events: 1565 other events

Deaths: 0 deaths

Placebo: Base Study

Serious events: 17 serious events

Other events: 1390 other events

Deaths: 0 deaths

qHPV Vaccine: EXT1

Serious events: 6 serious events

Other events: 2 other events

Deaths: 0 deaths

Long-term Follow-up: EXT2

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	qHPV Vaccine: Base Study n=1890 participants at risk Participants received qHPV vaccination at Day 1, Month 2, and Month 6 and were followed up to approximately Month 48	Placebo: Base Study n=1888 participants at risk Participants received placebo at Day 1, Month 2, and Month 6 and were followed up to approximately Month 48	qHPV Vaccine: EXT1 n=1327 participants at risk Participants who received placebo or an incomplete regimen of qHPV in the Base Study were offered open-label qHPV vaccine starting at approximately Month 60 (EXT1) and were followed up to Month 67	Long-term Follow-up: EXT2 n=1336 participants at risk Participants at sites in Colombia who received qHPV vaccination in the Base Study or in EXT1 were followed from Month 72 up to approximately Month 120 in LTFU (EXT2)
General disorders Injection site erythema	14.6% 275/1890 • Number of events 392 • Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2). Base Study: MedDRA v12.0; EXT1: MedDRA v14.1; LTFU (EXT2): MedDRA v18.1. Adverse events are reported for all participants who received ≥1 dose of qHPV or placebo and had safety follow-up data. Although other AEs were not solicited in EXT1 and LTFU (EXT2), some were voluntarily reported.	10.6% 200/1888 • Number of events 280 • Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2). Base Study: MedDRA v12.0; EXT1: MedDRA v14.1; LTFU (EXT2): MedDRA v18.1. Adverse events are reported for all participants who received ≥1 dose of qHPV or placebo and had safety follow-up data. Although other AEs were not solicited in EXT1 and LTFU (EXT2), some were voluntarily reported.	0.00% 0/1327 • Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2). Base Study: MedDRA v12.0; EXT1: MedDRA v14.1; LTFU (EXT2): MedDRA v18.1. Adverse events are reported for all participants who received ≥1 dose of qHPV or placebo and had safety follow-up data. Although other AEs were not solicited in EXT1 and LTFU (EXT2), some were voluntarily reported.	0.00% 0/1336 • Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2). Base Study: MedDRA v12.0; EXT1: MedDRA v14.1; LTFU (EXT2): MedDRA v18.1. Adverse events are reported for all participants who received ≥1 dose of qHPV or placebo and had safety follow-up data. Although other AEs were not solicited in EXT1 and LTFU (EXT2), some were voluntarily reported.
General disorders Injection site pain	75.3% 1424/1890 • Number of events 3168 • Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2). Base Study: MedDRA v12.0; EXT1: MedDRA v14.1; LTFU (EXT2): MedDRA v18.1. Adverse events are reported for all participants who received ≥1 dose of qHPV or placebo and had safety follow-up data. Although other AEs were not solicited in EXT1 and LTFU (EXT2), some were voluntarily reported.	62.1% 1173/1888 • Number of events 2252 • Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2). Base Study: MedDRA v12.0; EXT1: MedDRA v14.1; LTFU (EXT2): MedDRA v18.1. Adverse events are reported for all participants who received ≥1 dose of qHPV or placebo and had safety follow-up data. Although other AEs were not solicited in EXT1 and LTFU (EXT2), some were voluntarily reported.	0.00% 0/1327 • Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2). Base Study: MedDRA v12.0; EXT1: MedDRA v14.1; LTFU (EXT2): MedDRA v18.1. Adverse events are reported for all participants who received ≥1 dose of qHPV or placebo and had safety follow-up data. Although other AEs were not solicited in EXT1 and LTFU (EXT2), some were voluntarily reported.	0.00% 0/1336 • Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2). Base Study: MedDRA v12.0; EXT1: MedDRA v14.1; LTFU (EXT2): MedDRA v18.1. Adverse events are reported for all participants who received ≥1 dose of qHPV or placebo and had safety follow-up data. Although other AEs were not solicited in EXT1 and LTFU (EXT2), some were voluntarily reported.
General disorders Injection site swelling	18.8% 356/1890 • Number of events 530 • Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2). Base Study: MedDRA v12.0; EXT1: MedDRA v14.1; LTFU (EXT2): MedDRA v18.1. Adverse events are reported for all participants who received ≥1 dose of qHPV or placebo and had safety follow-up data. Although other AEs were not solicited in EXT1 and LTFU (EXT2), some were voluntarily reported.	11.4% 215/1888 • Number of events 293 • Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2). Base Study: MedDRA v12.0; EXT1: MedDRA v14.1; LTFU (EXT2): MedDRA v18.1. Adverse events are reported for all participants who received ≥1 dose of qHPV or placebo and had safety follow-up data. Although other AEs were not solicited in EXT1 and LTFU (EXT2), some were voluntarily reported.	0.00% 0/1327 • Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2). Base Study: MedDRA v12.0; EXT1: MedDRA v14.1; LTFU (EXT2): MedDRA v18.1. Adverse events are reported for all participants who received ≥1 dose of qHPV or placebo and had safety follow-up data. Although other AEs were not solicited in EXT1 and LTFU (EXT2), some were voluntarily reported.	0.00% 0/1336 • Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2). Base Study: MedDRA v12.0; EXT1: MedDRA v14.1; LTFU (EXT2): MedDRA v18.1. Adverse events are reported for all participants who received ≥1 dose of qHPV or placebo and had safety follow-up data. Although other AEs were not solicited in EXT1 and LTFU (EXT2), some were voluntarily reported.
General disorders Pyrexia	11.6% 219/1890 • Number of events 295 • Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2). Base Study: MedDRA v12.0; EXT1: MedDRA v14.1; LTFU (EXT2): MedDRA v18.1. Adverse events are reported for all participants who received ≥1 dose of qHPV or placebo and had safety follow-up data. Although other AEs were not solicited in EXT1 and LTFU (EXT2), some were voluntarily reported.	12.3% 232/1888 • Number of events 298 • Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2). Base Study: MedDRA v12.0; EXT1: MedDRA v14.1; LTFU (EXT2): MedDRA v18.1. Adverse events are reported for all participants who received ≥1 dose of qHPV or placebo and had safety follow-up data. Although other AEs were not solicited in EXT1 and LTFU (EXT2), some were voluntarily reported.	0.00% 0/1327 • Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2). Base Study: MedDRA v12.0; EXT1: MedDRA v14.1; LTFU (EXT2): MedDRA v18.1. Adverse events are reported for all participants who received ≥1 dose of qHPV or placebo and had safety follow-up data. Although other AEs were not solicited in EXT1 and LTFU (EXT2), some were voluntarily reported.	0.00% 0/1336 • Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2). Base Study: MedDRA v12.0; EXT1: MedDRA v14.1; LTFU (EXT2): MedDRA v18.1. Adverse events are reported for all participants who received ≥1 dose of qHPV or placebo and had safety follow-up data. Although other AEs were not solicited in EXT1 and LTFU (EXT2), some were voluntarily reported.
Infections and infestations Influenza	5.2% 98/1890 • Number of events 107 • Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2). Base Study: MedDRA v12.0; EXT1: MedDRA v14.1; LTFU (EXT2): MedDRA v18.1. Adverse events are reported for all participants who received ≥1 dose of qHPV or placebo and had safety follow-up data. Although other AEs were not solicited in EXT1 and LTFU (EXT2), some were voluntarily reported.	5.3% 101/1888 • Number of events 113 • Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2). Base Study: MedDRA v12.0; EXT1: MedDRA v14.1; LTFU (EXT2): MedDRA v18.1. Adverse events are reported for all participants who received ≥1 dose of qHPV or placebo and had safety follow-up data. Although other AEs were not solicited in EXT1 and LTFU (EXT2), some were voluntarily reported.	0.00% 0/1327 • Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2). Base Study: MedDRA v12.0; EXT1: MedDRA v14.1; LTFU (EXT2): MedDRA v18.1. Adverse events are reported for all participants who received ≥1 dose of qHPV or placebo and had safety follow-up data. Although other AEs were not solicited in EXT1 and LTFU (EXT2), some were voluntarily reported.	0.00% 0/1336 • Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2). Base Study: MedDRA v12.0; EXT1: MedDRA v14.1; LTFU (EXT2): MedDRA v18.1. Adverse events are reported for all participants who received ≥1 dose of qHPV or placebo and had safety follow-up data. Although other AEs were not solicited in EXT1 and LTFU (EXT2), some were voluntarily reported.
Nervous system disorders Headache	27.9% 528/1890 • Number of events 857 • Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2). Base Study: MedDRA v12.0; EXT1: MedDRA v14.1; LTFU (EXT2): MedDRA v18.1. Adverse events are reported for all participants who received ≥1 dose of qHPV or placebo and had safety follow-up data. Although other AEs were not solicited in EXT1 and LTFU (EXT2), some were voluntarily reported.	27.5% 519/1888 • Number of events 787 • Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2). Base Study: MedDRA v12.0; EXT1: MedDRA v14.1; LTFU (EXT2): MedDRA v18.1. Adverse events are reported for all participants who received ≥1 dose of qHPV or placebo and had safety follow-up data. Although other AEs were not solicited in EXT1 and LTFU (EXT2), some were voluntarily reported.	0.15% 2/1327 • Number of events 2 • Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2). Base Study: MedDRA v12.0; EXT1: MedDRA v14.1; LTFU (EXT2): MedDRA v18.1. Adverse events are reported for all participants who received ≥1 dose of qHPV or placebo and had safety follow-up data. Although other AEs were not solicited in EXT1 and LTFU (EXT2), some were voluntarily reported.	0.00% 0/1336 • Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2). Base Study: MedDRA v12.0; EXT1: MedDRA v14.1; LTFU (EXT2): MedDRA v18.1. Adverse events are reported for all participants who received ≥1 dose of qHPV or placebo and had safety follow-up data. Although other AEs were not solicited in EXT1 and LTFU (EXT2), some were voluntarily reported.

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 The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication or presentation
Publication restrictions are in place

Restriction type: OTHER