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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00090220
First received: August 25, 2004
Last updated: March 23, 2017
Last verified: March 2017
Results First Received: October 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Prevention
Conditions: Healthy Adult Female Participants
Prevention
Papillomavirus Infection
Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
Interventions: Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Biological: Comparator: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Base Study Vaccination Period covers Day 1 to Month 7; Base Study Follow-up Period covers Month 7 up to approximately Month 48; Extension 1 (EXT1) Period covers approximately Month 60 to Month 67; Long-term Follow-up (LTFU, EXT2) covers approximately Month 72 up to Month 120

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
qHPV Vaccine in Base Study Participants received Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (qHPV, Gardasil) at Day 1, Month 2, and Month 6
Placebo in Base Study Participants received placebo at Day 1, Month 2, and Month 6
Placebo in Base Study: EXT1 Participants who received placebo in the Base Study were offered open-label qHPV vaccine at EXT1 Day 1 (approximately 60 months after Day 1 of the Base Study), Month 2, and Month 6 and were followed to EXT1 Month 7 (approximately 67 months after Day 1 of the Base Study)
Incomplete qHPV Regimen in Base Study: EXT1 Participants who received an incomplete regimen of qHPV in the Base Study were offered open-label qHPV vaccine beginning at EXT1 Day 1 (approximately 60 months after Day 1 of the Base Study) and were followed to EXT1 Month 7 (approximately 67 months after Day 1 of the Base Study)
qHPV Vaccine in Base Study: LTFU (EXT2) Participants at sites in Colombia who received qHPV vaccination in the Base Study were followed from approximately Month 72 up to Month 120 (Year 10) after Day 1 in the Base Study
Placebo in Base Study and qHPV Vaccine in EXT1: LTFU (EXT2) Participants at sites in Colombia who received placebo or an incomplete regimen of qHPV in the Base Study and open-label qHPV in EXT1 were followed from approximately Month 72 up to Month 120 (Year 10) after Day 1 in the Base Study.

Participant Flow for 4 periods

Period 1:   Base Study Vaccination Period
    qHPV Vaccine in Base Study   Placebo in Base Study   Placebo in Base Study: EXT1   Incomplete qHPV Regimen in Base Study: EXT1   qHPV Vaccine in Base Study: LTFU (EXT2)   Placebo in Base Study and qHPV Vaccine in EXT1: LTFU (EXT2)
STARTED   1911   1908   0   0   0   0 
Vaccinated   1910   1907   0   0   0   0 
COMPLETED   1847   1845   0   0   0   0 
NOT COMPLETED   64   63   0   0   0   0 
Randomized not Vaccinated                1                1                0                0                0                0 
Adverse Event                6                1                0                0                0                0 
Lost to Follow-up                24                28                0                0                0                0 
Withdrawal by Subject                23                27                0                0                0                0 
Patient Moved                6                2                0                0                0                0 
Unspecified                4                4                0                0                0                0 

Period 2:   Base Study Follow-up Period
    qHPV Vaccine in Base Study   Placebo in Base Study   Placebo in Base Study: EXT1   Incomplete qHPV Regimen in Base Study: EXT1   qHPV Vaccine in Base Study: LTFU (EXT2)   Placebo in Base Study and qHPV Vaccine in EXT1: LTFU (EXT2)
STARTED   1855 [1]   1851 [2]   0   0   0   0 
COMPLETED   1695   1687   0   0   0   0 
NOT COMPLETED   160   164   0   0   0   0 
Adverse Event                6                1                0                0                0                0 
Lost to Follow-up                88                78                0                0                0                0 
Withdrawal by Subject                27                36                0                0                0                0 
Patient Moved                20                28                0                0                0                0 
Unspecified                19                21                0                0                0                0 
[1] 8 participants did not complete the Vaccination Period but entered the Follow-up Period.
[2] 5 participants did not complete the Vaccination Period but entered the Follow-up Period.

Period 3:   Extension 1 (EXT1)
    qHPV Vaccine in Base Study   Placebo in Base Study   Placebo in Base Study: EXT1   Incomplete qHPV Regimen in Base Study: EXT1   qHPV Vaccine in Base Study: LTFU (EXT2)   Placebo in Base Study and qHPV Vaccine in EXT1: LTFU (EXT2)
STARTED   0   0   1322 [1]   7 [1]   0   0 
Vaccinated   0   0   1321   7   0   0 
COMPLETED   0   0   1267   5   0   0 
NOT COMPLETED   0   0   55   2   0   0 
Adverse Event                0                0                4                0                0                0 
Lost to Follow-up                0                0                22                0                0                0 
Moved                0                0                2                1                0                0 
Withdrawal by Subject                0                0                25                0                0                0 
Protocol Violation                0                0                0                1                0                0 
Other reason                0                0                2                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   Placebo in Base Study: EXT1   Incomplete qHPV Regimen in Base Study: EXT1   qHPV Vaccine in Base Study: LTFU (EXT2)   Placebo in Base Study and qHPV Vaccine in EXT1: LTFU (EXT2)
STARTED   0   0   0   0   685 [1]   651 [1] 
COMPLETED   0   0   0   0   641   623 
NOT COMPLETED   0   0   0   0   44   28 
Lost to Follow-up                0                0                0                0                38                23 
Death                0                0                0                0                1                1 
Withdrawal by Subject                0                0                0                0                4                4 
Other                0                0                0                0                1                0 
[1] Participation in LTFU was voluntary; not all participants eligible for LTFU enrolled.



  Baseline Characteristics
  Hide 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.
All randomized participants

Reporting Groups
  Description
qHPV Vaccine in Base Study Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
Placebo in Base Study Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
Total Total of all reporting groups

Baseline Measures
   qHPV Vaccine in Base Study   Placebo in Base Study   Total 
Overall Participants Analyzed 
[Units: Participants]
 1911   1908   3819 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.3  (6.3)   34.3  (6.3)   34.3  (6.3) 
Age [1] 
[Units: Years]
Median (Full Range)
 35 
 (24 to 45) 
 34 
 (21 to 46) 
 34 
 (21 to 46) 
[1] Although the upper age limit for this study was 45 years old, one subject 46 years of age was randomized into the study.
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1911 100.0%      1908 100.0%      3819 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   596   596   1192 
Black   100   82   182 
Hispanic American   822   827   1649 
Native American   2   1   3 
White   388   397   785 
Multi-Racial   3   4   7 
Polynesian   0   1   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence Rate of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer   [ Time Frame: Up to 48 months (4 years) after the first dose of qHPV vaccine in the Base Study ]

2.  Primary:   Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study   [ Time Frame: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) ]

3.  Primary:   Number of Participants With Vaccine-Related SAEs After Vaccine Administration   [ Time Frame: qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120 ]

4.  Primary:   Number of Participants With an SAE Resulting in Death After Vaccine Administration   [ Time Frame: qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120 ]

5.  Primary:   Cumulative Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN) or Condyloma: Day 1 to Year 4   [ Time Frame: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) ]

6.  Primary:   Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 4 to 8   [ Time Frame: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study ]

7.  Primary:   Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 6 to 10   [ Time Frame: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study ]

8.  Primary:   Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Day 1 to Year 4   [ Time Frame: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) ]

9.  Primary:   Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 4 to 8   [ Time Frame: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study ]

10.  Primary:   Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 6 to 10   [ Time Frame: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study ]

11.  Primary:   Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study   [ Time Frame: Month 7 (1 month after the third dose of qHPV vaccine in the Base Study) ]

12.  Primary:   Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study   [ Time Frame: Month 12 (6 months after the third dose of qHPV vaccine in the Base Study) ]

13.  Primary:   Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study   [ Time Frame: Month 24 (18 months after the third dose of qHPV vaccine in the Base Study) ]

14.  Primary:   Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study   [ Time Frame: Month 36 (30 months after the third dose of qHPV vaccine in the Base Study) ]

15.  Primary:   Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study   [ Time Frame: Month 48 (42 months after the third dose of qHPV vaccine in the Base Study) ]

16.  Primary:   Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study   [ Time Frame: Month 72 (66 months after the third dose of qHPV vaccine in the Base Study) ]

17.  Primary:   Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study   [ Time Frame: Month 96 (90 months after the third dose of qHPV vaccine in the Base Study) ]

18.  Primary:   Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study   [ Time Frame: Month 120 (114 months after the third dose of qHPV vaccine in the Base Study) ]

19.  Primary:   Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study   [ Time Frame: Month 7 (1 month after the third dose of qHPV vaccine in the Base Study) ]

20.  Primary:   Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study   [ Time Frame: Month 12 (6 months after the third dose of qHPV vaccine in the Base Study) ]

21.  Primary:   Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study   [ Time Frame: Month 24 (18 months after the third dose of qHPV vaccine in the Base Study) ]

22.  Primary:   Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study   [ Time Frame: Month 36 (30 months after the third dose of qHPV vaccine in the Base Study) ]

23.  Primary:   Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study   [ Time Frame: Month 48 (42 months after the third dose of qHPV vaccine in the Base Study) ]

24.  Primary:   Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study   [ Time Frame: Month 72 (66 months after the third dose of qHPV vaccine in the Base Study) ]

25.  Primary:   Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study   [ Time Frame: Month 96 (96 months after the third dose of qHPV vaccine in the Base Study) ]

26.  Primary:   Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study   [ Time Frame: Month 120 (114 months after the third dose of qHPV vaccine in the Base Study) ]

27.  Secondary:   Incidence Rate of HPV 6/11 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer   [ Time Frame: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) ]

28.  Secondary:   Cumulative Incidence of HPV 6/11-related Condyloma: Day 1 to Year 4   [ Time Frame: Up to 48 months (4 years) after the first dose of qHPV vaccine or placebo in the Base Study ]

29.  Secondary:   Cumulative Incidence of HPV 6/11-related Condyloma: Year 4 to Year 8   [ Time Frame: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study ]

30.  Secondary:   Cumulative Incidence of HPV 6/11-related Condyloma: Year 6 to Year 10   [ Time Frame: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study ]

31.  Secondary:   Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Day 1 to Year 4   [ Time Frame: Up to 48 months (4 years) after the first dose of qHPV vaccine or placebo in the Base Study ]

32.  Secondary:   Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Year 4 to Year 8   [ Time Frame: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study ]

33.  Secondary:   Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Year 6 to Year 10   [ Time Frame: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study ]

34.  Secondary:   Incidence Rate of HPV 31/33/35/52/58 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer   [ Time Frame: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) ]

35.  Other Pre-specified:   Incidence Rate of HPV 16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer   [ Time Frame: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) ]

36.  Other Pre-specified:   Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Day 1 to Year 4   [ Time Frame: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) ]

37.  Other Pre-specified:   Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Year 4 to 8   [ Time Frame: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study ]

38.  Other Pre-specified:   Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Year 6 to 10   [ Time Frame: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study ]

39.  Other Pre-specified:   Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Day 1 to Year 4   [ Time Frame: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) ]

40.  Other Pre-specified:   Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Year 4 to 8   [ Time Frame: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study ]

41.  Other Pre-specified:   Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Year 6 to 10   [ Time Frame: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00090220     History of Changes
Other Study ID Numbers: V501-019
2004_013
Study First Received: August 25, 2004
Results First Received: October 30, 2009
Last Updated: March 23, 2017