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 : April 24, 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
Condition: Condylomata Acuminata
Interventions: Biological: (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
Biological: Comparator: placebo (unspecified)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 4164 participants were screened and 4065 were randomized

Reporting Groups
  Description
qHPV Vaccine in Base Study

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.

Placebo in 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.

EXT1: Placebo in Base Study

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.

EXT1: Incomplete qHPV Regimen in Base Study

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.

LTFU (EXT2): Early Vaccination Group 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).
LTFU (EXT2): Catch-up Vaccination Group 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).

Participant Flow for 4 periods

Period 1:   Base Study Vaccination Period
    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
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 
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 2:   Base Study Follow-up Period
    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
STARTED   1822 [1]   1821 [2]   0   0   0   0 
COMPLETED   1487   1479   0   0   0   0 
NOT COMPLETED   335   342   0   0   0   0 
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 3:   Extension 1
    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
STARTED   0   0   1098 [1]   16 [1]   0   0 
COMPLETED   0   0   1041   15   0   0 
NOT COMPLETED   0   0   57   1   0   0 
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 4:   Long-term Follow-up (EXT2)
    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
STARTED   0   0   0   0   936 [1]   867 [1] 
COMPLETED   0   0   0   0   709   664 
NOT COMPLETED   0   0   0   0   227   203 
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)



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
qHPV Vaccine in Base Study

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.

Placebo in 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.

Total Total of all reporting groups

Baseline Measures
   qHPV Vaccine in Base Study   Placebo in Base Study   Total 
Overall Participants Analyzed 
[Units: Participants]
 2032   2033   4065 
Age 
[Units: Years]
Mean (Standard Deviation)
 20.6  (2.0)   20.5  (2.0)   20.5  (2.0) 
Age [1] 
[Units: Years]
Median (Full Range)
 20 
 (16 to 26) 
 20 
 (15 to 27) 
 20 
 (15 to 27) 
[1] Although the upper age limit for this study was 26 years old, one subject age 27 was randomized into the study.
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      2032 100.0%      2033 100.0%      4065 100.0% 
Race/Ethnicity, Customized 
[Units: 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 


  Outcome Measures

1.  Primary:   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   [ Time Frame: Base study: through Month 36 ]

Measure Type Primary
Measure 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
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
qHPV Vaccine in Base Study

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.

Placebo in 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.


Measured Values
   qHPV Vaccine in Base Study   Placebo in Base Study 
Participants Analyzed   1394   1404 
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 
[Units: Incidence per 100 person-years]
 0.1   1.0 


Statistical Analysis 1 for 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
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Risk Difference (RD) [3] 90.6
95% Confidence Interval 70.1 to 98.2
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter.



2.  Primary:   Overall Study: Incidence of HPV Type 6/11-related Genital Warts   [ Time Frame: Up to 10 years after the first dose of qHPV vaccine ]

Measure Type Primary
Measure Title Overall Study: Incidence of HPV Type 6/11-related Genital Warts
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
qHPV Vaccine in Base Study 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.

Measured Values
   qHPV Vaccine in Base Study 
Participants Analyzed   1243 
Overall Study: Incidence of HPV Type 6/11-related Genital Warts 
[Units: Incidence per 10,000 person-years]
Number (95% Confidence Interval)
 4.3 
 (0.9 to 12.5) 

No statistical analysis provided for Overall Study: Incidence of HPV Type 6/11-related Genital Warts



3.  Primary:   Overall Study: Incidence of HPV Type 6/11/16/18-related External Genital Warts, PIN, Penile, Perianal or Perineal Cancer   [ Time Frame: Up to 10 years after the first dose of qHPV vaccine ]

Measure Type Primary
Measure Title Overall Study: Incidence of HPV Type 6/11/16/18-related External Genital Warts, PIN, Penile, Perianal or Perineal Cancer
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
qHPV Vaccine in Base Study

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.


Measured Values
   qHPV Vaccine in Base Study 
Participants Analyzed   1395 
Overall Study: Incidence of HPV Type 6/11/16/18-related External Genital Warts, PIN, Penile, Perianal or Perineal Cancer 
[Units: Incidence per 10,000 person-years]
Number (95% Confidence Interval)
 3.8 
 (0.8 to 11.1) 

No statistical analysis provided for Overall Study: Incidence of HPV Type 6/11/16/18-related External Genital Warts, PIN, Penile, Perianal or Perineal Cancer



4.  Primary:   Overall Study: Incidence of HPV Type 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer   [ Time Frame: Up to 10 years after the first dose of qHPV vaccine ]

Measure Type Primary
Measure Title Overall Study: Incidence of HPV Type 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
MSM qHPV Vaccine in Base Study

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.


Measured Values
   MSM qHPV Vaccine in Base Study 
Participants Analyzed   194 
Overall Study: Incidence of HPV Type 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer 
[Units: Incidence per 10,000 person-years]
Number (95% Confidence Interval)
 69.3 
 (25.4 to 150.8) 

No statistical analysis provided for Overall Study: Incidence of HPV Type 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer



5.  Primary:   Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs)   [ Time Frame: Base study: through Day 5 after any vaccination ]

Measure Type Primary
Measure Title Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs)
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis population included all vaccinated participants excluding 6 participants who received non-compliant mixed regimens of qHPV vaccine and placebo.

Reporting Groups
  Description
qHPV Vaccine in Base Study

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.

Placebo in 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.


Measured Values
   qHPV Vaccine in Base Study   Placebo in Base Study 
Participants Analyzed   2020   2029 
Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs) 
[Units: Participants]
Count of Participants
 25   20 

No statistical analysis provided for Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs)



6.  Primary:   Base Study: Number of Participants With Vaccine-Related Serious Adverse Events (SAEs)   [ Time Frame: Base study: through Month 36 ]

Measure Type Primary
Measure Title Base Study: Number of Participants With Vaccine-Related Serious Adverse Events (SAEs)
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis population included all vaccinated participants excluding 6 participants who received non-compliant mixed regimens of qHPV vaccine and placebo.

Reporting Groups
  Description
qHPV Vaccine: Base Study and Followup

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.

Placebo: Base Study and Followup

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.


Measured Values
   qHPV Vaccine: Base Study and Followup   Placebo: Base Study and Followup 
Participants Analyzed   2020   2029 
Base Study: Number of Participants With Vaccine-Related Serious Adverse Events (SAEs) 
[Units: Participants]
Count of Participants
 0   0 

No statistical analysis provided for Base Study: Number of Participants With Vaccine-Related Serious Adverse Events (SAEs)



7.  Primary:   LTFU (EXT2): Number of Participants With Vaccine-Related SAEs   [ 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 ]

Measure Type Primary
Measure Title LTFU (EXT2): Number of Participants With Vaccine-Related SAEs
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
LTFU (EXT2): Early Vaccination Group 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).
LTFU (EXT2): Catch-up Vaccination Group 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).

Measured Values
   LTFU (EXT2): Early Vaccination Group   LTFU (EXT2): Catch-up Vaccination Group 
Participants Analyzed   936   867 
LTFU (EXT2): Number of Participants With Vaccine-Related SAEs 
[Units: Participants]
Count of Participants
 0   0 

No statistical analysis provided for LTFU (EXT2): Number of Participants With Vaccine-Related SAEs



8.  Primary:   LTFU (EXT2): Number of Participants Who Died   [ 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 ]

Measure Type Primary
Measure Title LTFU (EXT2): Number of Participants Who Died
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
LTFU (EXT2): Early Vaccination Group 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).
LTFU (EXT2): Catch-up Vaccination Group 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).

Measured Values
   LTFU (EXT2): Early Vaccination Group   LTFU (EXT2): Catch-up Vaccination Group 
Participants Analyzed   936   867 
LTFU (EXT2): Number of Participants Who Died 
[Units: Participants]
Count of Participants
 5   2 

No statistical analysis provided for LTFU (EXT2): Number of Participants Who Died



9.  Secondary:   Base Study: Incidence of HPV 6/11/16/18-related Persistent Infection   [ Time Frame: Base study: through Month 36 ]

Measure Type Secondary
Measure Title Base Study: Incidence of HPV 6/11/16/18-related Persistent Infection
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
qHPV Vaccine in Base Study

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.

Placebo in 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.


Measured Values
   qHPV Vaccine in Base Study   Placebo in Base Study 
Participants Analyzed   1390   1402 
Base Study: Incidence of HPV 6/11/16/18-related Persistent Infection 
[Units: Infection per 100 person-years]
 0.7   4.8 


Statistical Analysis 1 for Base Study: Incidence of HPV 6/11/16/18-related Persistent Infection
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Risk Difference (RD) [3] 85.5
95% Confidence Interval 77.0 to 91.3
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  CI based on binomial tail probabilities and not from a dispersion parameter. Hochberg multiplicity adjustment applied to the CI.



10.  Secondary:   Base Study: Incidence of HPV 6/11/16/18-related Deoxyribonucleic Acid (DNA) Detection   [ Time Frame: Base study: through Month 36 ]

Measure Type Secondary
Measure Title Base Study: Incidence of HPV 6/11/16/18-related Deoxyribonucleic Acid (DNA) Detection
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
qHPV Vaccine in Base Study

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.

Placebo in 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.


Measured Values
   qHPV Vaccine in Base Study   Placebo in Base Study 
Participants Analyzed   1390   1402 
Base Study: Incidence of HPV 6/11/16/18-related Deoxyribonucleic Acid (DNA) Detection 
[Units: Detection per 100 person-years]
 5.3   10.7 


Statistical Analysis 1 for Base Study: Incidence of HPV 6/11/16/18-related Deoxyribonucleic Acid (DNA) Detection
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Risk Difference (RD) [3] 51.0
95% Confidence Interval 40.3 to 59.9
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  CI based on binomial tail probabilities and not from a dispersion parameter. Hochberg multiplicity adjustment applied to the CI.



11.  Secondary:   Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 7 Assessed by Competitive Luminex Immunoassay (cLIA)   [ Time Frame: Month 7 ]

Measure Type Secondary
Measure Title Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 7 Assessed by Competitive Luminex Immunoassay (cLIA)
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
qHPV Vaccine in Base Study

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.


Measured Values
   qHPV Vaccine in Base Study 
Participants Analyzed   2025 
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 7 Assessed by Competitive Luminex Immunoassay (cLIA) 
[Units: cLIA mMU/mL]
Geometric Mean (95% Confidence Interval)
 
HPV Type 6   
Participants Analyzed   1090 
HPV Type 6   447.7 
 (415.9 to 481.9) 
HPV Type 11   
Participants Analyzed   1090 
HPV Type 11   624.4 
 (588.4 to 662.6) 
HPV Type 16   
Participants Analyzed   1133 
HPV Type 16   2406.1 
 (2245.0 to 2578.8) 
HPV Type 18   
Participants Analyzed   1173 
HPV Type 18   402.8 
 (373.9 to 433.9) 

No statistical analysis provided for Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 7 Assessed by Competitive Luminex Immunoassay (cLIA)



12.  Secondary:   Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA   [ Time Frame: Month 36 ]

Measure Type Secondary
Measure Title Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
qHPV Vaccine in Base Study

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.


Measured Values
   qHPV Vaccine in Base Study 
Participants Analyzed   2025 
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA 
[Units: cLIA mMU/mL]
Geometric Mean (95% Confidence Interval)
 
HPV Type 6   
Participants Analyzed   845 
HPV Type 6   71.5 
 (66.7 to 76.7) 
HPV Type 11   
Participants Analyzed   845 
HPV Type 11   82.5 
 (77.0 to 88.5) 
HPV Type 16   
Participants Analyzed   875 
HPV Type 16   293.6 
 (271.6 to 317.4) 
HPV Type 18   
Participants Analyzed   904 
HPV Type 18   33.2 
 (30.2 to 36.4) 

No statistical analysis provided for Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA



13.  Secondary:   Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 72 Assessed by cLIA   [ Time Frame: Month 72 ]

Measure Type Secondary
Measure Title Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 72 Assessed by cLIA
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
qHPV Vaccine in Base Study

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.


Measured Values
   qHPV Vaccine in Base Study 
Participants Analyzed   2025 
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 72 Assessed by cLIA 
[Units: cLIA mMU/mL]
Geometric Mean (95% Confidence Interval)
 
HPV Type 6   
Participants Analyzed   575 
HPV Type 6   57.2 
 (52.3 to 62.5) 
HPV Type 11   
Participants Analyzed   575 
HPV Type 11   62.1 
 (56.7 to 68.1) 
HPV Type 16   
Participants Analyzed   609 
HPV Type 16   249.4 
 (225.6 to 275.8) 
HPV Type 18   
Participants Analyzed   633 
HPV Type 18   25.9 
 (23.2 to 28.9) 

No statistical analysis provided for Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 72 Assessed by cLIA



14.  Secondary:   Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by cLIA   [ Time Frame: Month 120 ]

Measure Type Secondary
Measure Title Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by cLIA
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
qHPV Vaccine in Base Study

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.


Measured Values
   qHPV Vaccine in Base Study 
Participants Analyzed   2025 
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by cLIA 
[Units: cLIA mMU/mL]
Geometric Mean (95% Confidence Interval)
 
HPV Type 6   
Participants Analyzed   374 
HPV Type 6   49.4 
 (44.1 to 55.4) 
HPV Type 11   
Participants Analyzed   374 
HPV Type 11   38.7 
 (34.5 to 43.5) 
HPV Type 16   
Participants Analyzed   393 
HPV Type 16   182.9 
 (161.4 to 207.3) 
HPV Type 18   
Participants Analyzed   408 
HPV Type 18   17.6 
 (15.5 to 19.9) 

No statistical analysis provided for Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by cLIA



15.  Secondary:   Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 7 Assessed by cLIA   [ Time Frame: Month 7 ]

Measure Type Secondary
Measure Title Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 7 Assessed by cLIA
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
qHPV Vaccine in Base Study

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.


Measured Values
   qHPV Vaccine in Base Study 
Participants Analyzed   2025 
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 7 Assessed by cLIA 
[Units: Percentage of participants]
Number (95% Confidence Interval)
 
HPV Type 6   
Participants Analyzed   1090 
HPV Type 6   98.9 
 (98.1 to 99.4) 
HPV Type 11   
Participants Analyzed   1090 
HPV Type 11   99.2 
 (98.4 to 99.6) 
HPV Type 16   
Participants Analyzed   1133 
HPV Type 16   98.8 
 (97.9 to 99.3) 
HPV Type 18   
Participants Analyzed   1173 
HPV Type 18   97.4 
 (96.3 to 98.2) 

No statistical analysis provided for Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 7 Assessed by cLIA



16.  Secondary:   Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 36 Assessed by cLIA   [ Time Frame: Month 36 ]

Measure Type Secondary
Measure Title Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 36 Assessed by cLIA
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
qHPV Vaccine in Base Study

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.


Measured Values
   qHPV Vaccine in Base Study 
Participants Analyzed   2025 
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 36 Assessed by cLIA 
[Units: Percentage of participants]
Number (95% Confidence Interval)
 
HPV Type 6   
Participants Analyzed   845 
HPV Type 6   88.9 
 (86.6 to 90.9) 
HPV Type 11   
Participants Analyzed   845 
HPV Type 11   94.0 
 (92.1 to 95.5) 
HPV Type 16   
Participants Analyzed   875 
HPV Type 16   97.9 
 (96.8 to 98.8) 
HPV Type 18   
Participants Analyzed   904 
HPV Type 18   57.1 
 (53.8 to 60.3) 

No statistical analysis provided for Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 36 Assessed by cLIA



17.  Secondary:   Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 72 Assessed by cLIA   [ Time Frame: Month 72 ]

Measure Type Secondary
Measure Title Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 72 Assessed by cLIA
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
qHPV Vaccine in Base Study

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.


Measured Values
   qHPV Vaccine in Base Study 
Participants Analyzed   2025 
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 72 Assessed by cLIA 
[Units: Percentage of participants]
Number (95% Confidence Interval)
 
HPV Type 6   
Participants Analyzed   575 
HPV Type 6   84.3 
 (81.1 to 87.2) 
HPV Type 11   
Participants Analyzed   575 
HPV Type 11   88.0 
 (85.1 to 90.5) 
HPV Type 16   
Participants Analyzed   609 
HPV Type 16   97.0 
 (95.4 to 98.2) 
HPV Type 18   
Participants Analyzed   633 
HPV Type 18   49.6 
 (45.6 to 53.6) 

No statistical analysis provided for Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 72 Assessed by cLIA



18.  Secondary:   Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by cLIA   [ Time Frame: Month 120 ]

Measure Type Secondary
Measure Title Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by cLIA
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
qHPV Vaccine in Base Study

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.


Measured Values
   qHPV Vaccine in Base Study 
Participants Analyzed   2025 
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by cLIA 
[Units: Percentage of participants]
Number (95% Confidence Interval)
 
HPV Type 6   
Participants Analyzed   374 
HPV Type 6   79.1 
 (74.7 to 83.2) 
HPV Type 11   
Participants Analyzed   374 
HPV Type 11   79.9 
 (75.5 to 83.9) 
HPV Type 16   
Participants Analyzed   393 
HPV Type 16   94.9 
 (92.2 to 96.9) 
HPV Type 18   
Participants Analyzed   408 
HPV Type 18   40.2 
 (35.4 to 45.1) 

No statistical analysis provided for Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by cLIA



19.  Secondary:   Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)   [ Time Frame: Month 120 ]

Measure Type Secondary
Measure Title Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
qHPV Vaccine in Base Study

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.


Measured Values
   qHPV Vaccine in Base Study 
Participants Analyzed   2025 
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) 
[Units: IgG LIA mMU/mL]
Geometric Mean (95% Confidence Interval)
 
HPV Type 6   
Participants Analyzed   278 
HPV Type 6   38.8 
 (34.0 to 44.2) 
HPV Type 11   
Participants Analyzed   274 
HPV Type 11   31.0 
 (27.2 to 35.3) 
HPV Type 16   
Participants Analyzed   291 
HPV Type 16   162.0 
 (141.2 to 185.7) 
HPV Type 18   
Participants Analyzed   305 
HPV Type 18   19.7 
 (17.0 to 22.9) 

No statistical analysis provided for Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)



20.  Secondary:   Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by IgG LIA   [ Time Frame: Month 120 ]

Measure Type Secondary
Measure Title Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by IgG LIA
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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..

Reporting Groups
  Description
qHPV Vaccine in Base Study

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.


Measured Values
   qHPV Vaccine in Base Study 
Participants Analyzed   2025 
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by IgG LIA 
[Units: Percentage of participants]
Number (95% Confidence Interval)
 
HPV Type 6   
Participants Analyzed   278 
HPV Type 6   91.7 
 (87.8 to 94.7) 
HPV Type 11   
Participants Analyzed   274 
HPV Type 11   92.0 
 (88.1 to 94.9) 
HPV Type 16   
Participants Analyzed   291 
HPV Type 16   99.7 
 (98.1 to 100) 
HPV Type 18   
Participants Analyzed   305 
HPV Type 18   92.1 
 (88.5 to 94.9) 

No statistical analysis provided for Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by IgG LIA



21.  Other Pre-specified:   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)   [ Time Frame: Base study: through Month 36 ]

Measure Type Other Pre-specified
Measure 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)
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
qHPV Vaccine in Base Study

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.

Placebo in 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.


Measured Values
   qHPV Vaccine in Base Study   Placebo in Base Study 
Participants Analyzed   194   208 
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) 
[Units: Incidence per 100 person-years]
 1.3   5.8 


Statistical Analysis 1 for 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)
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Risk Difference (RD) [3] 77.5
95% Confidence Interval 39.6 to 93.3
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information