We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Investigational Study of Gardasil™ (qHPV Vaccine) in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00090285
Recruitment Status : Completed
First Posted : August 27, 2004
Results First Posted : November 19, 2009
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Condylomata Acuminata
Interventions Biological: (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
Biological: Comparator: placebo (unspecified)
Enrollment 4065
Recruitment Details  
Pre-assignment Details A total of 4164 participants were screened and 4065 were randomized
Arm/Group Title qHPV Vaccine in Base Study Placebo in Base Study EXT1: Placebo in Base Study EXT1: Incomplete qHPV Regimen in Base Study LTFU (EXT2): Early Vaccination Group LTFU (EXT2): Catch-up Vaccination Group
Hide Arm/Group Description

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received quadrivalent human papillomavirus (qHPV) vaccination at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

Participants in the placebo arm in the base study were offered 3 doses of open-label qHPV vaccine at Extension 1 (EXT1) Day 1, Month 2 and Month 6.

Participants were followed to EXT1 Month 7.

Participants who received only 1 dose of qHPV vaccine in the Base Study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the Base Study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1).

Participants were followed to EXT1 Month 7.

Participants received ≥1 dose of qHPV vaccine in Base Study and were followed up to a total of 10 years after their first dose of qHPV vaccine. No vaccinations were administered during Long-term Follow-up (LTFU) (EXT2). Participants received placebo in Base Study and qHPV vaccine in EXT1 and were followed up to a total of 7 years after their first dose of qHPV vaccine. No vaccinations were administered during LTFU (EXT2).
Period Title: Base Study Vaccination Period
Started 2032 2033 0 0 0 0
Vaccinated 2025 2030 0 0 0 0
Completed 1818 1814 0 0 0 0
Not Completed 214 219 0 0 0 0
Reason Not Completed
Randomized Not Vaccinated             7             3             0             0             0             0
Adverse Event             2             4             0             0             0             0
Lost to Follow-up             111             112             0             0             0             0
Protocol Violation             2             3             0             0             0             0
Withdrawal by Subject             64             69             0             0             0             0
Uncooperative             2             2             0             0             0             0
Moved             20             21             0             0             0             0
Site Terminated             1             0             0             0             0             0
Other             2             2             0             0             0             0
Subject Incarcerated             2             2             0             0             0             0
HIV positive             1             1             0             0             0             0
Period Title: Base Study Follow-up Period
Started 1822 [1] 1821 [2] 0 0 0 0
Completed 1487 1479 0 0 0 0
Not Completed 335 342 0 0 0 0
Reason Not Completed
Adverse Event             3             10             0             0             0             0
Lost to Follow-up             232             226             0             0             0             0
Withdrawal by Subject             53             64             0             0             0             0
Moved             41             36             0             0             0             0
Other             2             0             0             0             0             0
Protocol Violation             1             0             0             0             0             0
Uncooperative             3             4             0             0             0             0
Subject Incarcerated             0             2             0             0             0             0
[1]
4 subjects who did not receive 3 doses of vaccine in base study continued into the Follow-up Period
[2]
7 subjects who did not receive 3 doses of placebo in base study continued into the Follow-up Period
Period Title: Extension 1
Started 0 0 1098 [1] 16 [1] 0 0
Completed 0 0 1041 15 0 0
Not Completed 0 0 57 1 0 0
Reason Not Completed
Adverse Event             0             0             2             0             0             0
Lost to Follow-up             0             0             35             0             0             0
Withdrawal by Subject             0             0             13             1             0             0
Other             0             0             4             0             0             0
Moved             0             0             3             0             0             0
[1]
Participation in EXT1 was voluntary; not all participants eligible for EXT1 enrolled.
Period Title: Long-term Follow-up (EXT2)
Started 0 0 0 0 936 [1] 867 [1]
Completed 0 0 0 0 709 664
Not Completed 0 0 0 0 227 203
Reason Not Completed
Adverse Event             0             0             0             0             5             2
Lost to Follow-up             0             0             0             0             156             143
Withdrawal by Subject             0             0             0             0             60             53
Physician Decision             0             0             0             0             6             5
[1]
Not all eligible participants enrolled in LTFU (EXT2)
Arm/Group Title qHPV Vaccine in Base Study Placebo in Base Study Total
Hide Arm/Group Description

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

Total of all reporting groups
Overall Number of Baseline Participants 2032 2033 4065
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2032 participants 2033 participants 4065 participants
20.6  (2.0) 20.5  (2.0) 20.5  (2.0)
Age, Continuous   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 2032 participants 2033 participants 4065 participants
20
(16 to 26)
20
(15 to 27)
20
(15 to 27)
[1]
Measure Description: Although the upper age limit for this study was 26 years old, one subject age 27 was randomized into the study.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2032 participants 2033 participants 4065 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
2032
 100.0%
2033
 100.0%
4065
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2032 participants 2033 participants 4065 participants
Asian 201 205 406
Black 405 400 805
Hispanic American 412 423 835
Native American 1 2 3
White 719 712 1431
Multi-Racial 291 283 574
Indian (subcontinent) 1 8 9
Polynesian 2 0 2
1.Primary Outcome
Title Base Study: Incidence of Human Papillomavirus (HPV) Type 6/11/16/18-related External Genital Warts, Penile/Perianal/Perineal Intraepithelial Neoplasia (PIN), Penile, Perianal or Perineal Cancer
Hide Description Participants with HPV 6/11/16/18-related external genital warts, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal or perineal cancer per 100 person-years of follow-up was assessed.
Time Frame Base study: through Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Participants must have received 3 doses of qHPV vaccine or placebo, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7.
Arm/Group Title qHPV Vaccine in Base Study Placebo in Base Study
Hide Arm/Group Description:

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

Overall Number of Participants Analyzed 1394 1404
Measure Type: Number
Unit of Measure: Incidence per 100 person-years
0.1 1.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection qHPV Vaccine in Base Study, Placebo in Base Study
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 90.6
Confidence Interval 95%
70.1 to 98.2
Estimation Comments Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter.
2.Primary Outcome
Title Overall Study: Incidence of HPV Type 6/11-related Genital Warts
Hide Description Incidence of HPV Type 6/11-related genital warts is expressed as events per 10,000 person-years of follow-up.
Time Frame Up to 10 years after the first dose of qHPV vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
Participants must have received 3 doses of qHPV vaccine, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7. This endpoint applied only to participants in the Base Study qHPV vaccine group.
Arm/Group Title qHPV Vaccine in Base Study
Hide Arm/Group Description:
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Overall Number of Participants Analyzed 1243
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Incidence per 10,000 person-years
4.3
(0.9 to 12.5)
3.Primary Outcome
Title Overall Study: Incidence of HPV Type 6/11/16/18-related External Genital Warts, PIN, Penile, Perianal or Perineal Cancer
Hide Description Incidence of HPV Type 6/11/16/18-related external genital warts, PIN, penile, perianal or perineal cancer is expressed as events per 10,000 person-years of follow-up.
Time Frame Up to 10 years after the first dose of qHPV vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
Participants must have received 3 doses of qHPV vaccine, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7. This endpoint applied only to participants in the Base Study qHPV vaccine group.
Arm/Group Title qHPV Vaccine in Base Study
Hide Arm/Group Description:

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

Overall Number of Participants Analyzed 1395
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Incidence per 10,000 person-years
3.8
(0.8 to 11.1)
4.Primary Outcome
Title Overall Study: Incidence of HPV Type 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer
Hide Description Incidence of HPV Type 6/11/16/18-related AIN and anal cancer is expressed as events per 10,000 person-years of follow-up. MSM is men having sex with men.
Time Frame Up to 10 years after the first dose of qHPV vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
Participants must have received 3 doses of qHPV vaccine, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7. This endpoint applied only to MSM in the Base Study qHPV vaccine group.
Arm/Group Title MSM qHPV Vaccine in Base Study
Hide Arm/Group Description:

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

Overall Number of Participants Analyzed 194
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Incidence per 10,000 person-years
69.3
(25.4 to 150.8)
5.Primary Outcome
Title Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs)
Hide Description An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an adverse experience. A severe AE is incapacitating with inability to work or do usual activities.
Time Frame Base study: through Day 5 after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all vaccinated participants excluding 6 participants who received non-compliant mixed regimens of qHPV vaccine and placebo.
Arm/Group Title qHPV Vaccine in Base Study Placebo in Base Study
Hide Arm/Group Description:

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

Overall Number of Participants Analyzed 2020 2029
Measure Type: Count of Participants
Unit of Measure: Participants
25
   1.2%
20
   1.0%
6.Primary Outcome
Title Base Study: Number of Participants With Vaccine-Related Serious Adverse Events (SAEs)
Hide Description A serious adverse event is an AE that 1) results in death, 2) is life threatening, 3) results in persistent or significant disability or incapacity, 4) results in or prolongs an existing hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) based on appropriate medical judgment may jeopardize the participant and may require medical or surgical intervention. A vaccine-related AE is one deemed to be possibly, probably or definitely related to study vaccine by the investigator.
Time Frame Base study: through Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all vaccinated participants excluding 6 participants who received non-compliant mixed regimens of qHPV vaccine and placebo.
Arm/Group Title qHPV Vaccine: Base Study and Followup Placebo: Base Study and Followup
Hide Arm/Group Description:

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the base study encompassed Month 7 through Month 36. The at-risk population was participants who received ≥ 1 qHPV vaccination in the base study.

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.

Follow-up for the base study encompassed Month 7 through Month 36. The at-risk population was participants who received ≥ 1 placebo injection in the base study.

Overall Number of Participants Analyzed 2020 2029
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
7.Primary Outcome
Title LTFU (EXT2): Number of Participants With Vaccine-Related SAEs
Hide Description An SAE is an AE that 1) results in death, 2) is life threatening, 3) results in persistent or significant disability or incapacity, 4) results in or prolongs an existing hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) based on appropriate medical judgment may jeopardize the participant and may require medical or surgical intervention. A vaccine-related AE is one deemed to be possibly, probably or definitely related to study vaccine by the investigator.
Time Frame LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
The population analyzed was all randomized participants receiving at least 1 dose of qHPV vaccine in the Base Study or EXT1 and enrolled in LTFU (EXT2).
Arm/Group Title LTFU (EXT2): Early Vaccination Group LTFU (EXT2): Catch-up Vaccination Group
Hide Arm/Group Description:
Participants received ≥1 dose of qHPV vaccine in Base Study and were followed up to a total of 10 years after their first dose of qHPV vaccine. No vaccinations were administered during Long-term Follow-up (LTFU) (EXT2).
Participants received placebo in Base Study and qHPV vaccine in EXT1 and were followed up to a total of 7 years after their first dose of qHPV vaccine. No vaccinations were administered during LTFU (EXT2).
Overall Number of Participants Analyzed 936 867
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
8.Primary Outcome
Title LTFU (EXT2): Number of Participants Who Died
Hide Description The number of participants who died was assessed.
Time Frame LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
The population analyzed was all randomized participants receiving at least 1 dose of qHPV vaccine in the Base Study or EXT1 and enrolled in LTFU (EXT2).
Arm/Group Title LTFU (EXT2): Early Vaccination Group LTFU (EXT2): Catch-up Vaccination Group
Hide Arm/Group Description:
Participants received ≥1 dose of qHPV vaccine in Base Study and were followed up to a total of 10 years after their first dose of qHPV vaccine. No vaccinations were administered during Long-term Follow-up (LTFU) (EXT2).
Participants received placebo in Base Study and qHPV vaccine in EXT1 and were followed up to a total of 7 years after their first dose of qHPV vaccine. No vaccinations were administered during LTFU (EXT2).
Overall Number of Participants Analyzed 936 867
Measure Type: Count of Participants
Unit of Measure: Participants
5
   0.5%
2
   0.2%
9.Secondary Outcome
Title Base Study: Incidence of HPV 6/11/16/18-related Persistent Infection
Hide Description Participants with HPV Type 6/11/16/18-related persistent infection per 100 person-years of follow-up was assessed.
Time Frame Base study: through Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Participants must have received 3 doses of qHPV vaccine or placebo, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7.
Arm/Group Title qHPV Vaccine in Base Study Placebo in Base Study
Hide Arm/Group Description:

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

Overall Number of Participants Analyzed 1390 1402
Measure Type: Number
Unit of Measure: Infection per 100 person-years
0.7 4.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection qHPV Vaccine in Base Study, Placebo in Base Study
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 85.5
Confidence Interval 95%
77.0 to 91.3
Estimation Comments CI based on binomial tail probabilities and not from a dispersion parameter. Hochberg multiplicity adjustment applied to the CI.
10.Secondary Outcome
Title Base Study: Incidence of HPV 6/11/16/18-related Deoxyribonucleic Acid (DNA) Detection
Hide Description Participants with HPV 6/11/16/18-related DNA detection per 100 person-years of follow-up was assessed.
Time Frame Base study: through Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Participants must have received 3 doses of qHPV vaccine or placebo, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7.
Arm/Group Title qHPV Vaccine in Base Study Placebo in Base Study
Hide Arm/Group Description:

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

Overall Number of Participants Analyzed 1390 1402
Measure Type: Number
Unit of Measure: Detection per 100 person-years
5.3 10.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection qHPV Vaccine in Base Study, Placebo in Base Study
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 51.0
Confidence Interval 95%
40.3 to 59.9
Estimation Comments CI based on binomial tail probabilities and not from a dispersion parameter. Hochberg multiplicity adjustment applied to the CI.
11.Secondary Outcome
Title Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 7 Assessed by Competitive Luminex Immunoassay (cLIA)
Hide Description Antibodies to HPV types were measured using cLIA. Antibody titers were expressed as cLIA milli Merck units/mL (cLIA mMU/mL).
Time Frame Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.
Arm/Group Title qHPV Vaccine in Base Study
Hide Arm/Group Description:

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

Overall Number of Participants Analyzed 2025
Geometric Mean (95% Confidence Interval)
Unit of Measure: cLIA mMU/mL
HPV Type 6 Number Analyzed 1090 participants
447.7
(415.9 to 481.9)
HPV Type 11 Number Analyzed 1090 participants
624.4
(588.4 to 662.6)
HPV Type 16 Number Analyzed 1133 participants
2406.1
(2245.0 to 2578.8)
HPV Type 18 Number Analyzed 1173 participants
402.8
(373.9 to 433.9)
12.Secondary Outcome
Title Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA
Hide Description Antibodies to HPV types were measured using cLIA. Antibody titers were expressed as cLIA milli Merck units/mL (cLIA mMU/mL).
Time Frame Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.
Arm/Group Title qHPV Vaccine in Base Study
Hide Arm/Group Description:

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

Overall Number of Participants Analyzed 2025
Geometric Mean (95% Confidence Interval)
Unit of Measure: cLIA mMU/mL
HPV Type 6 Number Analyzed 845 participants
71.5
(66.7 to 76.7)
HPV Type 11 Number Analyzed 845 participants
82.5
(77.0 to 88.5)
HPV Type 16 Number Analyzed 875 participants
293.6
(271.6 to 317.4)
HPV Type 18 Number Analyzed 904 participants
33.2
(30.2 to 36.4)
13.Secondary Outcome
Title Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 72 Assessed by cLIA
Hide Description Antibodies to HPV types were measured using cLIA. Antibody titers were expressed as cLIA milli Merck units/mL (cLIA mMU/mL).
Time Frame Month 72
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.
Arm/Group Title qHPV Vaccine in Base Study
Hide Arm/Group Description:

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the Base Study was through Month 36 and for LTFU (EXT2) was through Month 120.

Overall Number of Participants Analyzed 2025
Geometric Mean (95% Confidence Interval)
Unit of Measure: cLIA mMU/mL
HPV Type 6 Number Analyzed 575 participants
57.2
(52.3 to 62.5)
HPV Type 11 Number Analyzed 575 participants
62.1
(56.7 to 68.1)
HPV Type 16 Number Analyzed 609 participants
249.4
(225.6 to 275.8)
HPV Type 18 Number Analyzed 633 participants
25.9
(23.2 to 28.9)
14.Secondary Outcome
Title Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by cLIA
Hide Description Antibodies to HPV types were measured using cLIA. Antibody titers were expressed as cLIA milli Merck units/mL (cLIA mMU/mL).
Time Frame Month 120
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.
Arm/Group Title qHPV Vaccine in Base Study
Hide Arm/Group Description:

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the Base Study was through Month 36 and for LTFU (EXT2) was through Month 120.

Overall Number of Participants Analyzed 2025
Geometric Mean (95% Confidence Interval)
Unit of Measure: cLIA mMU/mL
HPV Type 6 Number Analyzed 374 participants
49.4
(44.1 to 55.4)
HPV Type 11 Number Analyzed 374 participants
38.7
(34.5 to 43.5)
HPV Type 16 Number Analyzed 393 participants
182.9
(161.4 to 207.3)
HPV Type 18 Number Analyzed 408 participants
17.6
(15.5 to 19.9)
15.Secondary Outcome
Title Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 7 Assessed by cLIA
Hide Description Antibodies to HPV types were measured using cLIA. Thresholds for seropositive were ≥20, 16, 20, and 24 cLIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.
Time Frame Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.
Arm/Group Title qHPV Vaccine in Base Study
Hide Arm/Group Description:

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

Overall Number of Participants Analyzed 2025
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
HPV Type 6 Number Analyzed 1090 participants
98.9
(98.1 to 99.4)
HPV Type 11 Number Analyzed 1090 participants
99.2
(98.4 to 99.6)
HPV Type 16 Number Analyzed 1133 participants
98.8
(97.9 to 99.3)
HPV Type 18 Number Analyzed 1173 participants
97.4
(96.3 to 98.2)
16.Secondary Outcome
Title Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 36 Assessed by cLIA
Hide Description Antibodies to HPV types were measured using cLIA. Thresholds for seropositive were ≥20, 16, 20, and 24 cLIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.
Time Frame Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.
Arm/Group Title qHPV Vaccine in Base Study
Hide Arm/Group Description:

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

Overall Number of Participants Analyzed 2025
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
HPV Type 6 Number Analyzed 845 participants
88.9
(86.6 to 90.9)
HPV Type 11 Number Analyzed 845 participants
94.0
(92.1 to 95.5)
HPV Type 16 Number Analyzed 875 participants
97.9
(96.8 to 98.8)
HPV Type 18 Number Analyzed 904 participants
57.1
(53.8 to 60.3)
17.Secondary Outcome
Title Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 72 Assessed by cLIA
Hide Description Antibodies to HPV types were measured using cLIA. Thresholds for seropositive were ≥20, 16, 20, and 24 cLIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.
Time Frame Month 72
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.
Arm/Group Title qHPV Vaccine in Base Study
Hide Arm/Group Description:

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the Base Study was through Month 36 and for LTFU (EXT2) was through Month 120.

Overall Number of Participants Analyzed 2025
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
HPV Type 6 Number Analyzed 575 participants
84.3
(81.1 to 87.2)
HPV Type 11 Number Analyzed 575 participants
88.0
(85.1 to 90.5)
HPV Type 16 Number Analyzed 609 participants
97.0
(95.4 to 98.2)
HPV Type 18 Number Analyzed 633 participants
49.6
(45.6 to 53.6)
18.Secondary Outcome
Title Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by cLIA
Hide Description Antibodies to HPV types were measured using cLIA. Thresholds for seropositive were ≥20, 16, 20, and 24 cLIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.
Time Frame Month 120
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.
Arm/Group Title qHPV Vaccine in Base Study
Hide Arm/Group Description:

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the Base Study was through Month 36 and for LTFU (EXT2) was through Month 120.

Overall Number of Participants Analyzed 2025
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
HPV Type 6 Number Analyzed 374 participants
79.1
(74.7 to 83.2)
HPV Type 11 Number Analyzed 374 participants
79.9
(75.5 to 83.9)
HPV Type 16 Number Analyzed 393 participants
94.9
(92.2 to 96.9)
HPV Type 18 Number Analyzed 408 participants
40.2
(35.4 to 45.1)
19.Secondary Outcome
Title Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Hide Description Antibodies to HPV types were measured using Luminex immunoassay (IgG-LIA). The unit of measure for this assay is IgG LIA mMU/mL; this unit cannot be directly compared with the cLIA mMU/mL unit reported for the cLIA results.
Time Frame Month 120
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.
Arm/Group Title qHPV Vaccine in Base Study
Hide Arm/Group Description:

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the Base Study was through Month 36 and for LTFU (EXT2) was through Month 120.

Overall Number of Participants Analyzed 2025
Geometric Mean (95% Confidence Interval)
Unit of Measure: IgG LIA mMU/mL
HPV Type 6 Number Analyzed 278 participants
38.8
(34.0 to 44.2)
HPV Type 11 Number Analyzed 274 participants
31.0
(27.2 to 35.3)
HPV Type 16 Number Analyzed 291 participants
162.0
(141.2 to 185.7)
HPV Type 18 Number Analyzed 305 participants
19.7
(17.0 to 22.9)
20.Secondary Outcome
Title Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by IgG LIA
Hide Description Antibodies to HPV types were measured using IgG LIA. Thresholds for seropositive were ≥9, 6, 5, and 5 IgG LIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.
Time Frame Month 120
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study..
Arm/Group Title qHPV Vaccine in Base Study
Hide Arm/Group Description:

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the Base Study was through Month 36 and for LTFU (EXT2) was through Month 120.

Overall Number of Participants Analyzed 2025
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
HPV Type 6 Number Analyzed 278 participants
91.7
(87.8 to 94.7)
HPV Type 11 Number Analyzed 274 participants
92.0
(88.1 to 94.9)
HPV Type 16 Number Analyzed 291 participants
99.7
(98.1 to 100)
HPV Type 18 Number Analyzed 305 participants
92.1
(88.5 to 94.9)
21.Other Pre-specified Outcome
Title Base Study: Substudy to Evaluate the Incidence of HPV 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer in Men Having Sex With Men (MSM)
Hide Description Participants with HPV 6/11/16/18-related AIN or anal cancer per 100 person-years of follow-up was assessed.
Time Frame Base study: through Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Only a subset of participants was included for this sub-study. Participants must have received 3 doses of qHPV vaccine or placebo, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7.
Arm/Group Title qHPV Vaccine in Base Study Placebo in Base Study
Hide Arm/Group Description:

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

Overall Number of Participants Analyzed 194 208
Measure Type: Number
Unit of Measure: Incidence per 100 person-years
1.3 5.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection qHPV Vaccine in Base Study, Placebo in Base Study
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 77.5
Confidence Interval 95%
39.6 to 93.3
Estimation Comments [Not Specified]
Time Frame Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Adverse Event Reporting Description

Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2).

Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data.

Other AEs were not solicited during EXT1 or LTFU (EXT2).

 
Arm/Group Title qHPV Vaccine: Base Study Placebo: Base Study qHPV Vaccine: EXT1 LTFU (EXT2)
Hide Arm/Group Description The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6. The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6. Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the base study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1). Participants received ≥1 dose of qHPV vaccine in Base Study, or received placebo in Base Study and qHPV vaccine in EXT1. This arm includes both groups enrolled in LTFU (EXT2): Early Vaccination Group and Catch-up Vaccination Group.
All-Cause Mortality
qHPV Vaccine: Base Study Placebo: Base Study qHPV Vaccine: EXT1 LTFU (EXT2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/2020 (0.15%)      10/2029 (0.49%)      2/1084 (0.18%)      7/1803 (0.39%)    
Hide Serious Adverse Events
qHPV Vaccine: Base Study Placebo: Base Study qHPV Vaccine: EXT1 LTFU (EXT2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/2020 (0.40%)      11/2029 (0.54%)      3/1084 (0.28%)      7/1803 (0.39%)    
Cardiac disorders         
Cardiac arrest   1/2020 (0.05%)  1 0/2029 (0.00%)  0 0/1084 (0.00%)  0 0/1803 (0.00%)  0
Myocardial ischaemia   0/2020 (0.00%)  0 1/2029 (0.05%)  1 0/1084 (0.00%)  0 0/1803 (0.00%)  0
Pericardial haemorrhage   0/2020 (0.00%)  0 1/2029 (0.05%)  1 0/1084 (0.00%)  0 0/1803 (0.00%)  0
Myocardial infarction   0/2020 (0.00%)  0 0/2029 (0.00%)  0 0/1084 (0.00%)  0 1/1803 (0.06%)  1
General disorders         
Non-cardiac chest pain   1/2020 (0.05%)  1 0/2029 (0.00%)  0 0/1084 (0.00%)  0 0/1803 (0.00%)  0
Immune system disorders         
Hypersensitivity   1/2020 (0.05%)  1 0/2029 (0.00%)  0 0/1084 (0.00%)  0 0/1803 (0.00%)  0
Infections and infestations         
Appendicitis   1/2020 (0.05%)  1 0/2029 (0.00%)  0 0/1084 (0.00%)  0 0/1803 (0.00%)  0
Cellulitis   1/2020 (0.05%)  1 0/2029 (0.00%)  0 0/1084 (0.00%)  0 0/1803 (0.00%)  0
Varicella   1/2020 (0.05%)  1 0/2029 (0.00%)  0 0/1084 (0.00%)  0 0/1803 (0.00%)  0
Pneumonia   0/2020 (0.00%)  0 0/2029 (0.00%)  0 1/1084 (0.09%)  1 1/1803 (0.06%)  1
HIV infection   0/2020 (0.00%)  0 0/2029 (0.00%)  0 0/1084 (0.00%)  0 1/1803 (0.06%)  1
Injury, poisoning and procedural complications         
Accidental overdose   0/2020 (0.00%)  0 1/2029 (0.05%)  1 1/1084 (0.09%)  1 0/1803 (0.00%)  0
Cervical vertebral fracture   1/2020 (0.05%)  1 0/2029 (0.00%)  0 0/1084 (0.00%)  0 0/1803 (0.00%)  0
Chemical poisoning   0/2020 (0.00%)  0 1/2029 (0.05%)  1 0/1084 (0.00%)  0 0/1803 (0.00%)  0
Contusion   0/2020 (0.00%)  0 1/2029 (0.05%)  1 0/1084 (0.00%)  0 0/1803 (0.00%)  0
Gun shot wound   1/2020 (0.05%)  1 3/2029 (0.15%)  3 1/1084 (0.09%)  1 1/1803 (0.06%)  1
Head injury   0/2020 (0.00%)  0 1/2029 (0.05%)  1 0/1084 (0.00%)  0 0/1803 (0.00%)  0
Multiple drug overdose   0/2020 (0.00%)  0 1/2029 (0.05%)  1 0/1084 (0.00%)  0 0/1803 (0.00%)  0
Road traffic accident   1/2020 (0.05%)  1 1/2029 (0.05%)  1 0/1084 (0.00%)  0 1/1803 (0.06%)  1
Traumatic brain injury   1/2020 (0.05%)  1 0/2029 (0.00%)  0 0/1084 (0.00%)  0 0/1803 (0.00%)  0
Traumatic intracranial haemorrhage   1/2020 (0.05%)  1 0/2029 (0.00%)  0 0/1084 (0.00%)  0 0/1803 (0.00%)  0
Blast injury   0/2020 (0.00%)  0 0/2029 (0.00%)  0 0/1084 (0.00%)  0 1/1803 (0.06%)  1
Burns second degree   0/2020 (0.00%)  0 0/2029 (0.00%)  0 0/1084 (0.00%)  0 1/1803 (0.06%)  1
Craniocerebral injury   0/2020 (0.00%)  0 0/2029 (0.00%)  0 0/1084 (0.00%)  0 1/1803 (0.06%)  1
Subarachnoid haemorrhage   0/2020 (0.00%)  0 0/2029 (0.00%)  0 0/1084 (0.00%)  0 1/1803 (0.06%)  1
Metabolism and nutrition disorders         
Metabolic acidosis   0/2020 (0.00%)  0 0/2029 (0.00%)  0 0/1084 (0.00%)  0 1/1803 (0.06%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Neuroma   0/2020 (0.00%)  0 0/2029 (0.00%)  0 0/1084 (0.00%)  0 1/1803 (0.06%)  1
Nervous system disorders         
Convulsion   1/2020 (0.05%)  1 0/2029 (0.00%)  0 0/1084 (0.00%)  0 0/1803 (0.00%)  0
Cerebral haemorrhage   0/2020 (0.00%)  0 0/2029 (0.00%)  0 0/1084 (0.00%)  0 1/1803 (0.06%)  1
Psychiatric disorders         
Completed suicide   0/2020 (0.00%)  0 2/2029 (0.10%)  2 0/1084 (0.00%)  0 0/1803 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
qHPV Vaccine: Base Study Placebo: Base Study qHPV Vaccine: EXT1 LTFU (EXT2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1277/2020 (63.22%)      1183/2029 (58.30%)      0/0      0/0    
Gastrointestinal disorders         
Abdominal pain upper   19/2020 (0.94%)  21 23/2029 (1.13%)  23 0/0  0 0/0  0
Diarrhoea   40/2020 (1.98%)  44 36/2029 (1.77%)  38 0/0  0 0/0  0
Nausea   27/2020 (1.34%)  30 16/2029 (0.79%)  16 0/0  0 0/0  0
General disorders         
Pyrexia   118/2020 (5.84%)  131 125/2029 (6.16%)  149 0/0  0 0/0  0
Injection Site Erythema   304/2020 (15.05%)  446 275/2029 (13.55%)  384 0/0  0 0/0  0
Injection Site Pain   1116/2020 (55.25%)  2087 992/2029 (48.89%)  1767 0/0  0 0/0  0
Injection Site Pruritus   23/2020 (1.14%)  27 24/2029 (1.18%)  29 0/0  0 0/0  0
Injection Site Swelling   219/2020 (10.84%)  318 187/2029 (9.22%)  270 0/0  0 0/0  0
Infections and infestations         
Influenza   42/2020 (2.08%)  43 44/2029 (2.17%)  47 0/0  0 0/0  0
Nasopharyngitis   44/2020 (2.18%)  46 50/2029 (2.46%)  59 0/0  0 0/0  0
Pharyngitis   22/2020 (1.09%)  23 20/2029 (0.99%)  21 0/0  0 0/0  0
Upper respiratory tract infection   27/2020 (1.34%)  28 20/2029 (0.99%)  22 0/0  0 0/0  0
Nervous system disorders         
Headache   179/2020 (8.86%)  222 207/2029 (10.20%)  275 0/0  0 0/0  0
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain   38/2020 (1.88%)  38 37/2029 (1.82%)  37 0/0  0 0/0  0
Indicates events were collected by systematic assessment
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.
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT00090285    
Other Study ID Numbers: V501-020
Formerly-0904HPVHMES
2004_103
2004-002945-10 ( EudraCT Number )
V501-020 ( Other Identifier: Merck Protocol Number )
First Submitted: August 25, 2004
First Posted: August 27, 2004
Results First Submitted: October 14, 2009
Results First Posted: November 19, 2009
Last Update Posted: August 23, 2018