Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil)(V501-015 AM5; EXT1; EXT2(AM1))

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092534
First received: September 23, 2004
Last updated: October 17, 2012
Last verified: October 2012
Results First Received: July 20, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Cervical Cancer
Genital Warts
Interventions: Biological: Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
Biological: Matching Placebo

  Participant Flow
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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
No text entered.

Reporting Groups
  Description
Quadrivalent Human Papillomavirus Vaccine (Group 1)

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

Placebo (Group 2)

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

Extension Study This group includes 581 subjects who received placebo during the base study, (Group 2-Base Study) and 13 additional subjects who were randomized to the active vaccine arm of the base study (from Group 1-Base Study), but received fewer than the full three doses of Quadrivalent HPV vaccine during the base study. Subjects designated as "Completed Period" are those who received three doses of Quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as "Not Completed" are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up.

Participant Flow for 3 periods

Period 1:   Base Study Vaccination Period
    Quadrivalent Human Papillomavirus Vaccine (Group 1)     Placebo (Group 2)     Extension Study  
STARTED     6087     6080     0  
COMPLETED     5916     5954     0  
NOT COMPLETED     171     126     0  
Randomized not Vaccinated                 5                 5                 0  
Adverse Event                 3                 1                 0  
Death                 5                 4                 0  
Lost to Follow-up                 41                 37                 0  
Physician Decision                 1                 0                 0  
Pregnancy                 9                 7                 0  
Protocol Violation                 2                 1                 0  
Withdrawal by Subject                 85                 58                 0  
Moved                 14                 12                 0  
New Medical History (Not AEs)                 5                 0                 0  
Travel                 1                 0                 0  
Site Closed                 0                 1                 0  

Period 2:   Base Study Follow Up Period
    Quadrivalent Human Papillomavirus Vaccine (Group 1)     Placebo (Group 2)     Extension Study  
STARTED     5942 [1]   5971 [1]   0  
COMPLETED     5626     5277     0  
NOT COMPLETED     316     694     0  
Adverse Event                 2                 4                 0  
Death                 2                 1                 0  
Lost to Follow-up                 120                 146                 0  
Pregnancy                 6                 10                 0  
Protocol Violation                 1                 2                 0  
Withdrawal by Subject                 71                 62                 0  
Moved                 62                 58                 0  
Travel                 10                 7                 0  
Site Closed                 0                 2                 0  
Subjects continuing                 27                 31                 0  
Subjects in extension                 15                 371                 0  
[1] Includes subjects who did not receive 3 doses of vaccine/placebo but continued into the follow-up.

Period 3:   Extension Study
    Quadrivalent Human Papillomavirus Vaccine (Group 1)     Placebo (Group 2)     Extension Study  
STARTED     0     0     594  
COMPLETED     0     0     449  
NOT COMPLETED     0     0     145  
Lost to Follow-up                 0                 0                 41  
Physician Decision                 0                 0                 1  
Pregnancy                 0                 0                 12  
Withdrawal by Subject                 0                 0                 18  
Moved                 0                 0                 6  
Travel                 0                 0                 2  
Site Closed                 0                 0                 21  
Study Ended                 0                 0                 29  
Protocol Deviation                 0                 0                 15  



  Baseline Characteristics
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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
Quadrivalent Human Papillomavirus Vaccine (Group 1)

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

Placebo (Group 2)

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

Total Total of all reporting groups

Baseline Measures
    Quadrivalent Human Papillomavirus Vaccine (Group 1)     Placebo (Group 2)     Total  
Number of Participants  
[units: participants]
  6087     6080     12167  
Age, Customized [1]
[units: participants]
     
Between 15 and 26 years     6087     6080     12167  
Age  
[units: years]
Mean ± Standard Deviation
  20.0  ± 2.2     19.9  ± 2.1     19.9  ± 2.1  
Gender  
[units: participants]
     
Female     6087     6080     12167  
Male     0     0     0  
Race/Ethnicity [2]
[units: participants]
     
Asian     151     135     286  
Black     171     227     398  
Hispanic American     555     557     1112  
Native American     1     1     2  
White     4584     4550     9134  
Other-Unspecified     625     610     1235  
[1] Age for study subjects was recorded at the time of subject entry into the base study.
[2] Subject race was determined at subject entry into the base study.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Tolerability; Incidence of the Composite Endpoint of HPV 16 or HPV 18 Related CIN2/3 or Invasive Cervical Carcinoma After Completion of the Vaccination Series for Relevant HPV Type   [ Time Frame: Follow-up through end of study (4 years) ]

2.  Secondary:   Subjects With Anti-HPV 6 Titer >/= 20 mMU/mL   [ Time Frame: week 4 Postdose 3 (4 weeks after 3rd vaccine dose) ]

3.  Secondary:   Subjects With Anti-HPV 11 Titer >/= 16 mMU/mL   [ Time Frame: week 4 Postdose 3 ]

4.  Secondary:   Subjects With Anti-HPV 16 Titer >/= 20 mMU/mL   [ Time Frame: week 4 Postdose 3 ]
  Hide Outcome Measure 4

Measure Type Secondary
Measure Title Subjects With Anti-HPV 16 Titer >/= 20 mMU/mL
Measure Description Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 20mMU/mL
Time Frame week 4 Postdose 3  
Safety Issue No  

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.
Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide data. Only subjects participating in a substudy had blood samples at Month 7.

Reporting Groups
  Description
Quadrivalent Human Papillomavirus Vaccine (Group 1)

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

Placebo (Group 2)

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.


Measured Values
    Quadrivalent Human Papillomavirus Vaccine (Group 1)     Placebo (Group 2)  
Number of Participants Analyzed  
[units: participants]
  1017     994  
Subjects With Anti-HPV 16 Titer >/= 20 mMU/mL  
[units: Participants]
  1014     15  

No statistical analysis provided for Subjects With Anti-HPV 16 Titer >/= 20 mMU/mL



5.  Secondary:   Subjects With Anti-HPV 18 Titer >/= 24 mMU/mL   [ Time Frame: week 4 Postdose 3 ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


Results Point of Contact:  
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


Publications:

Publications automatically indexed to this study:


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092534     History of Changes
Other Study ID Numbers: 2004_082, V501-015
Study First Received: September 23, 2004
Results First Received: July 20, 2009
Last Updated: October 17, 2012
Health Authority: United States: Food and Drug Administration