Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092521
First received: September 23, 2004
Last updated: November 27, 2013
Last verified: November 2013
Results First Received: August 3, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Cervical Cancer
Genital Warts
Interventions: Biological: V501
Biological: Comparator: Placebo
Biological: Human Papillomavirus (HPV) 16 Monovalent

  Participant Flow


  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
Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine

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.

Group 2 - Base Study Monovalent HPV (Type 16) Vaccine

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 the Monovalent (HPV 16) HPV vaccine.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

Group 3 - Base Study Placebo

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 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
    Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine     Group 2 - Base Study Monovalent HPV (Type 16) Vaccine     Group 3 - Base Study Placebo     Total  
Number of Participants  
[units: participants]
  2723     304     2732     5759  
Age  
[units: years]
Mean ± Standard Deviation
  20.2  ± 1.8     20.2  ± 1.74     20.3  ± 1.8     20.3  ± 1.8  
Age  
[units: Years]
Median ( Full Range )
  20  
  ( 16 to 24 )  
  20  
  ( 16 to 24 )  
  20  
  ( 16 to 24 )  
  20  
  ( 16 to 24 )  
Age, Customized [1]
[units: Participants]
       
16 to 24 Years of Age     2723     304     2732     5759  
Gender  
[units: participants]
       
Female     2723     304     2732     5759  
Male     0     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
       
Asian     151     27     165     343  
Black     136     5     167     308  
Hispanic American     567     93     566     1226  
Native American     10     2     10     22  
White     1600     171     1558     3329  
Other - Unspecified     259     6     266     531  
[1] Although the upper age limit for this study was 23 years old, four subjects aged 24 were randomized into the study.



  Outcome Measures
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1.  Primary:   Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer   [ Time Frame: Follow-up through end of study (4 years) ]

2.  Primary:   Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer]   [ Time Frame: Follow-up through end of study (4 years) ]


  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
e-mail: ClinicalTrialsDisclosure@merck.com


Publications:

Publications automatically indexed to this study:


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092521     History of Changes
Other Study ID Numbers: V501-013, 2004_081
Study First Received: September 23, 2004
Results First Received: August 3, 2009
Last Updated: November 27, 2013
Health Authority: United States: Food and Drug Administration