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

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ClinicalTrials.gov Identifier: NCT00092547
Recruitment Status : Completed
First Posted : September 28, 2004
Results First Posted : May 4, 2010
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Human
Papillomavirus Infections
Interventions Biological: V501
Biological: Comparator: Placebo
Enrollment 1781

Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title qHPV Vaccine in Base Study Placebo in Base Study qHPV Vaccine in Extension Study
Hide Arm/Group Description 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. 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. 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.
Period Title: Base Vaccine Phase (Day 1 to Month 7)
Started 1184 597 0
Vaccinated 1179 596 0
Completed 1121 561 0
Not Completed 63 36 0
Reason Not Completed
Not Vaccinated             5             1             0
Adverse Event             4             1             0
Lost to Follow-up             18             7             0
Withdrawal by Subject             28             21             0
Moved             3             1             0
per sponsor request: (noncompliant)             0             1             0
Did not meet local regulations             0             1             0
Refused Vaccination             5             3             0
Period Title: Base Follow-up Phase (Month 7 to 18)
Started 1128 [1] 565 [1] 0
Completed 1108 551 0
Not Completed 20 14 0
Reason Not Completed
Subject moved             1             5             0
Withdrawal by Subject             4             2             0
Lost to Follow-up             13             7             0
Protocol Violation             1             0             0
Physician Decision             1             0             0
[1]
Includes participants continuing and who previously discontinued who re-entered the study
Period Title: Base Follow-up Phase (Month 18 to 30)
Started 964 [1] 490 [1] 0
Completed 956 485 0
Not Completed 8 5 0
Reason Not Completed
Subject moved             4             2             0
Withdrawal by Subject             1             3             0
Lost to Follow-up             2             0             0
Protocol Violation             1             0             0
[1]
Includes participants continuing and who previously discontinued who re-entered the study
Period Title: Extension Vaccine Phase (Month 30 to 37)
Started 956 [1] 0 485 [1]
Vaccinated in Extension Study 0 0 482
Completed 933 0 469
Not Completed 23 0 16
Reason Not Completed
Subject moved             3             0             0
Withdrawal by Subject             6             0             9
Lost to Follow-up             14             0             7
[1]
Includes participants continuing and who previously discontinued who re-entered the study
Period Title: Long-term Follow-up (Month 42 Visit)
Started 612 [1] 0 308 [1]
Completed 611 0 308
Not Completed 1 0 0
Reason Not Completed
Adverse Event             1             0             0
[1]
Includes participants continuing and who previously discontinued who re-entered the study
Period Title: Long-term Follow-up (Month 72 Visit)
Started 550 [1] 0 276 [1]
Completed 550 0 276
Not Completed 0 0 0
[1]
Includes participants continuing and who previously discontinued who re-entered the study
Period Title: Long-term Follow-up (Month 96 Visit)
Started 508 [1] 0 267 [1]
Completed 508 0 267
Not Completed 0 0 0
[1]
Includes participants continuing and who previously discontinued who re-entered the study
Period Title: Long-term Follow-up (Month 126 Visit)
Started 454 0 211
Completed 454 0 211
Not Completed 0 0 0
Arm/Group Title qHPV Vaccine in Base Study Placebo in Base Study Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 1184 597 1781
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1184 participants 597 participants 1781 participants
11.9  (1.9) 11.8  (1.9) 11.9  (1.9)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1184 participants 597 participants 1781 participants
8 Years of Age and Under 0 0 0
9 to 16 Years of Age 1184 597 1781
17 Years of Age and Over 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1184 participants 597 participants 1781 participants
Female
616
  52.0%
322
  53.9%
938
  52.7%
Male
568
  48.0%
275
  46.1%
843
  47.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1184 participants 597 participants 1781 participants
Asian 149 70 219
Black 50 21 71
Hispanic American 260 130 390
Native American 0 1 1
White 716 369 1085
Other 9 6 15
1.Primary Outcome
Title Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18
Hide Description 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.
Time Frame Up to Month 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.
Arm/Group Title qHPV Vaccine in Base Study Placebo in Base Study
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 1165 584
Measure Type: Number
Unit of Measure: participants
6 0
2.Primary Outcome
Title Number of Participants Reporting SAEs From Month 18 Through Month 37
Hide Description Tolerability as assessed by the number of participants with clinical adverse experiences from Month 18 through Month 37
Time Frame Month 18 to Month 37
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.
Arm/Group Title qHPV Vaccine in Base Study qHPV Vaccine in Extension Study
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 923 477
Measure Type: Number
Unit of Measure: participants
0 3
3.Primary Outcome
Title Number of Participants Reporting Other (Non-serious) AEs Through Month 18
Hide Description Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18
Time Frame 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.
Arm/Group Title qHPV Vaccine in Base Study Placebo in Base Study
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 1165 584
Measure Type: Number
Unit of Measure: participants
918 340
4.Primary Outcome
Title Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72
Hide Description 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.
Time Frame Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title qHPV Vaccine in Base Study qHPV Vaccine in Extension Study
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 550 276
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Type 6: n=475, 151
93.3
(90.6 to 95.3)
91.4
(85.7 to 95.3)
Type 11: n=475, 151
96.0
(93.8 to 97.6)
96.7
(92.4 to 98.9)
Type 16: n=473, 154
97.9
(96.1 to 99.0)
97.4
(93.5 to 99.3)
Type 18: n=477, 160
74.4
(70.3 to 78.3)
79.4
(72.3 to 85.4)
5.Primary Outcome
Title Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72
Hide Description [Not Specified]
Time Frame Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title qHPV Vaccine in Base Study qHPV Vaccine in Extension Study
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 550 276
Geometric Mean (95% Confidence Interval)
Unit of Measure: milliMerck units/mL
Type 6: n=475, 151
118.9
(108.4 to 130.4)
113.9
(95.7 to 135.6)
Type 11: n=475, 151
135.7
(122.6 to 150.3)
137.9
(114.9 to 165.5)
Type 16: n=473, 154
521.2
(466.2 to 582.6)
485.8
(396.4 to 595.3)
Type 18: n=477, 160
70.9
(61.8 to 81.4)
67.7
(53.1 to 86.3)
6.Primary Outcome
Title Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96
Hide Description [Not Specified]
Time Frame Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Group and 60 Months Post-dose 3 for Extension Group)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title qHPV Vaccine in Base Study qHPV Vaccine in Extension Study
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 508 267
Geometric Mean (95% Confidence Interval)
Unit of Measure: milliMerck units/mL
Type 6: n=451, 141
71.4
(64.6 to 79.0)
91.0
(76.4 to 108.6)
Type 11: n=451, 141
67.5
(60.1 to 75.7)
90.3
(74.0 to 110.1)
Type 16: n=447, 143
325.5
(288.6 to 367.1)
387.4
(314.7 to 476.9)
Type 18: n=452, 152
41.6
(36.5 to 47.5)
48.3
(37.6 to 62.0)
7.Primary Outcome
Title Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96
Hide Description 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.
Time Frame Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Cohort and 60 Months Post-dose 3 for Extension Group)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title qHPV Vaccine in Base Study qHPV Vaccine in Extension Study
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 508 267
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Type 6: n=451, 141
88.2
(84.9 to 91.1)
91.5
(85.6 to 95.5)
Type 11: n=451, 141
89.1
(85.9 to 91.9)
93.6
(88.2 to 97.0)
Type 16: n=447, 143
96.9
(94.8 to 98.3)
97.9
(94.0 to 99.6)
Type 18: n=452, 152
63.9
(59.3 to 68.4)
69.1
(61.1 to 76.3)
8.Primary Outcome
Title Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126
Hide Description [Not Specified]
Time Frame Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title qHPV Vaccine in Base Study qHPV Vaccine in Extension Study
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 454 211
Geometric Mean (95% Confidence Interval)
Unit of Measure: milliMerck units/mL
Type 6: n=409, 112
88.0
(78.9 to 98.2)
99.3
(81.0 to 121.6)
Type 11: n=409, 112
74.6
(66.1 to 84.1)
96.0
(76.1 to 121.1)
Type 16: n=403, 115
320.1
(281.2 to 364.4)
351.6
(277.1 to 446.2)
Type 18: n=408, 120
36.5
(31.7 to 42.1)
39.6
(30.7 to 51.2)
9.Primary Outcome
Title Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126
Hide Description 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.
Time Frame Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title qHPV Vaccine in Base Study qHPV Vaccine in Extension Study
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 454 211
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Type 6: n=409, 112
89.0
(85.6 to 91.9)
91.1
(84.2 to 95.6)
Type 11: n=409, 112
88.8
(85.3 to 91.6)
92.9
(86.4 to 96.9)
Type 16: n=403, 115
96.0
(93.6 to 97.7)
96.5
(91.3 to 99.0)
Type 18: n=408, 120
60.5
(55.6 to 65.3)
65.0
(55.8 to 73.5)
10.Primary Outcome
Title Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up
Hide Description 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.
Time Frame Month 37 to Month 126
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population was all participants who were vaccinated according to actual treatment received and had safety follow-up.
Arm/Group Title qHPV Vaccine in Base Study qHPV Vaccine in Extension Study
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 821 424
Measure Type: Number
Unit of Measure: Participants
0 1
11.Secondary Outcome
Title Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7)
Hide Description 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.
Time Frame Month 7 (1 Month Postdose 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title qHPV Vaccine in Base Study
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 1082
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Type 6: n=953
99.8
(99.2 to 100)
Type 11: n=954
99.8
(99.2 to 100)
Type 16: n=949
99.7
(99.1 to 99.9)
Type 18: n=956
99.7
(99.1 to 99.9)
12.Secondary Outcome
Title Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (Month 18).
Hide Description 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.
Time Frame Month 18 (12 Months Post-dose 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title qHPV Vaccine in Base Study
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 1106
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Type 6: n=937
97.8
(96.6 to 98.6)
Type 11: n=938
99.3
(98.5 to 99.7)
Type 16: n=933
99.6
(98.9 to 99.9)
Type 18: n=940
91.6
(89.6 to 93.3)
13.Secondary Outcome
Title Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24)
Hide Description 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.
Time Frame Month 24 (18 Months Post-dose 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title qHPV Vaccine in Base Study
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 595
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Type 6: n=446
95.1
(92.6 to 96.9)
Type 11: n=447
98.2
(96.5 to 99.2)
Type 16: n=442
98.4
(96.8 to 99.4)
Type 18: n=447
87.5
(84.0 to 90.4)
14.Secondary Outcome
Title Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30)
Hide Description 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.
Time Frame Month 30 (24 Months Post-dose 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title qHPV Vaccine in Base Study
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 911
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Type 6: n=799
95.6
(94.0 to 96.9)
Type 11: n=800
97.5
(96.2 to 98.5)
Type 16: n=795
98.6
(97.5 to 99.3)
Type 18: n=803
84.3
(81.6 to 86.8)
15.Secondary Outcome
Title Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37).
Hide Description 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.
Time Frame Month 37 (31 Months Post-dose 3)
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Hide Analysis Population Description
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.
Arm/Group Title qHPV Vaccine in Base Study
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 772
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Type 6: n=657
94.5
(92.5 to 96.1)
Type 11: n=657
96.0
(94.3 to 97.4)
Type 16: n=655
98.2
(96.8 to 99.0)
Type 18: n=660
81.1
(77.9 to 84.0)
16.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Month 37 (1 Month Post-dose 3 of qHPV)
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Hide Analysis Population Description
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.
Arm/Group Title qHPV Vaccine in Extension Study
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 440
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Type 6: n=246
99.6
(97.8 to 100)
Type 11: n=246
100
(98.5 to 100)
Type 16: n=246
100
(98.5 to 100)
Type 18: n=255
98.8
(96.6 to 99.8)
17.Secondary Outcome
Title 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)
Hide Description [Not Specified]
Time Frame Month 7 (1 Month Post-dose 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title qHPV Vaccine in Base Study
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 1082
Geometric Mean (95% Confidence Interval)
Unit of Measure: milliMerck units/mL
Type 6: n=953
929.2
(871.0 to 991.4)
Type 11: n=954
1362.8
(1279.8 to 1451.3)
Type 16: n=949
5512.7
(5109.9 to 5947.2)
Type 18: n=956
1278.9
(1183.2 to 1382.4)
18.Secondary Outcome
Title 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)
Hide Description [Not Specified]
Time Frame Month 18 (Month 12 Post-dose 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title qHPV Vaccine in Base Study
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 1106
Geometric Mean (95% Confidence Interval)
Unit of Measure: milliMerck units/mL
Type 6: n=937
219.3
(204.9 to 234.7)
Type 11: n=938
296.9
(276.9 to 318.3)
Type 16: n=933
1314.8
(1220.5 to 1416.5)
Type 18: n=940
203.0
(184.1 to 223.9)
19.Secondary Outcome
Title 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)
Hide Description [Not Specified]
Time Frame Month 24 (18 Months Post-dose 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title qHPV Vaccine in Base Study
Hide Arm/Group Description:
Represent participants randomized to the qHPV vaccine group
Overall Number of Participants Analyzed 595
Geometric Mean (95% Confidence Interval)
Unit of Measure: milliMerck units/mL
Type 6: n=446
143.5
(129.2 to 159.5)
Type 11: n=447
206.6
(186.9 to 228.3)
Type 16: n=442
932.1
(833.3 to 1042.7)
Type 18: n=447
136.2
(118.5 to 156.6)
20.Secondary Outcome
Title 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)
Hide Description [Not Specified]
Time Frame Month 30 (24 Months Post-dose 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title qHPV Vaccine in Base Study
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 911
Geometric Mean (95% Confidence Interval)
Unit of Measure: milliMerck units/mL
Type 6: n=799
146.5
(135.6 to 158.2)
Type 11: n=800
177.0
(163.6 to 191.5)
Type 16: n=795
826.1
(757.8 to 900.5)
Type 18: n=803
114.7
(102.8 to 127.9)
21.Secondary Outcome
Title 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)
Hide Description [Not Specified]
Time Frame Month 37 (31 Months Post-dose 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title qHPV Vaccine in Base Study
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 772
Geometric Mean (95% Confidence Interval)
Unit of Measure: milliMerck units/mL
Type 6: n=657
128.6
(118.2 to 139.9)
Type 11: n=657
149.7
(137.0 to 163.6)
Type 16: n=655
680.4
(617.2 to 750.1)
Type 18: n=660
102.4
(90.9 to 115.3)
22.Secondary Outcome
Title 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)
Hide Description [Not Specified]
Time Frame Month 37 (1 Month Post-dose 3 of qHPV)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title qHPV Vaccine in Extension Study
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 440
Geometric Mean (95% Confidence Interval)
Unit of Measure: milliMerck units/mL
Type 6: n=246
768.6
(676.6 to 873.0)
Type 11: n=246
1041.0
(919.8 to 1178.2)
Type 16: n=246
4312.7
(3715.6 to 5005.7)
Type 18: n=255
830.1
(714.0 to 965.1)
23.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Up to Month 126
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Hide Analysis Population Description
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.
Arm/Group Title qHPV Vaccine in Base Study qHPV Vaccine in Extension Study
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 259 96
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Cases per 100 person-years at risk
0.2
(0.1 to 0.7)
0.2
(0.0 to 1.4)
24.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Up to Month 126
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title qHPV Vaccine in Base Study qHPV Vaccine in Extension Study
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 179 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Cases per 100 person-years at risk
0.6
(0.2 to 1.5)
0.3
(0.0 to 1.9)
Time Frame Day 1 to Month 30 and Month 30 to Month 126
Adverse Event Reporting Description 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.
 
Arm/Group Title qHPV Vaccine in Base: Vaccine Phase and Follow-up Placebo in Base: Vaccine Phase and Follow-up qHPV Vaccine in Base: Extension and Long-term Follow-up qHPV Vaccine in Extension: Extension and Long-term Follow-up
Hide Arm/Group Description 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.

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.

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. 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.
All-Cause Mortality
qHPV Vaccine in Base: Vaccine Phase and Follow-up Placebo in Base: Vaccine Phase and Follow-up qHPV Vaccine in Base: Extension and Long-term Follow-up qHPV Vaccine in Extension: Extension and Long-term Follow-up
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
qHPV Vaccine in Base: Vaccine Phase and Follow-up Placebo in Base: Vaccine Phase and Follow-up qHPV Vaccine in Base: Extension and Long-term Follow-up qHPV Vaccine in Extension: Extension and Long-term Follow-up
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/1165 (0.52%)      0/584 (0.00%)      2/932 (0.21%)      3/481 (0.62%)    
Blood and lymphatic system disorders         
Haemorrhagic anaemia * 1  1/1165 (0.09%)  1 0/584 (0.00%)  0 0/932 (0.00%)  0 0/481 (0.00%)  0
Gastrointestinal disorders         
Colitis ulcerative * 1  1/1165 (0.09%)  1 0/584 (0.00%)  0 0/932 (0.00%)  0 0/481 (0.00%)  0
General disorders         
Chest pain * 1  0/1165 (0.00%)  0 0/584 (0.00%)  0 0/932 (0.00%)  0 1/481 (0.21%)  1
Infections and infestations         
Appendicitis * 1  1/1165 (0.09%)  1 0/584 (0.00%)  0 0/932 (0.00%)  0 0/481 (0.00%)  0
Localised infection * 1  1/1165 (0.09%)  1 0/584 (0.00%)  0 0/932 (0.00%)  0 0/481 (0.00%)  0
Injury, poisoning and procedural complications         
Meniscus injury * 1  0/1165 (0.00%)  0 0/584 (0.00%)  0 0/932 (0.00%)  0 1/481 (0.21%)  1
Road traffic accident * 1  0/1165 (0.00%)  0 0/584 (0.00%)  0 1/932 (0.11%)  1 0/481 (0.00%)  0
Metabolism and nutrition disorders         
Type 1 diabetes mellitus * 1  1/1165 (0.09%)  1 0/584 (0.00%)  0 0/932 (0.00%)  0 0/481 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Pain in extremity * 1  1/1165 (0.09%)  1 0/584 (0.00%)  0 0/932 (0.00%)  0 0/481 (0.00%)  0
Nervous system disorders         
VIIth nerve paralysis * 1  0/1165 (0.00%)  0 0/584 (0.00%)  0 0/932 (0.00%)  0 1/481 (0.21%)  1
Tonic clonic movements * 1  0/1165 (0.00%)  0 0/584 (0.00%)  0 1/932 (0.11%)  1 0/481 (0.00%)  0
Renal and urinary disorders         
Acute kidney injury * 1  1/1165 (0.09%)  1 0/584 (0.00%)  0 0/932 (0.00%)  0 0/481 (0.00%)  0
Reproductive system and breast disorders         
Dysfunctional uterine bleeding * 1  1/1165 (0.09%)  1 0/584 (0.00%)  0 0/932 (0.00%)  0 0/481 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
qHPV Vaccine in Base: Vaccine Phase and Follow-up Placebo in Base: Vaccine Phase and Follow-up qHPV Vaccine in Base: Extension and Long-term Follow-up qHPV Vaccine in Extension: Extension and Long-term Follow-up
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   918/1165 (78.80%)      344/584 (58.90%)      0/932 (0.00%)      3/481 (0.62%)    
General disorders         
Injection site erythema * 1  237/1165 (20.34%)  323 78/584 (13.36%)  109 0/932 (0.00%)  0 1/481 (0.21%)  1
Injection site pain * 2  853/1165 (73.22%)  1705 268/584 (45.89%)  434 0/932 (0.00%)  0 3/481 (0.62%)  3
Injection site swelling * 2  241/1165 (20.69%)  336 45/584 (7.71%)  63 0/932 (0.00%)  0 1/481 (0.21%)  1
Pyrexia * 1  100/1165 (8.58%)  114 44/584 (7.53%)  60 0/932 (0.00%)  0 0/481 (0.00%)  0
Nervous system disorders         
Headache * 1  221/1165 (18.97%)  297 111/584 (19.01%)  163 0/932 (0.00%)  0 0/481 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain * 1  52/1165 (4.46%)  56 24/584 (4.11%)  26 0/932 (0.00%)  0 0/481 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 7.1
2
Term from vocabulary, MedDRA 11.0
The difference between the prior and final data is a minor change in the definition of the per-protocol immunogenicity population, which was applied down to the base study. Also, protocol violators were identified and excluded from the analysis.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092547     History of Changes
Other Study ID Numbers: V501-018
2004_084
First Submitted: September 23, 2004
First Posted: September 28, 2004
Results First Submitted: November 3, 2009
Results First Posted: May 4, 2010
Last Update Posted: February 20, 2018