Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil)(V501-015)

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: April 21, 2014
Last verified: April 2014
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


  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.
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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  
[units: years]
Mean ± Standard Deviation
  20.0  ± 2.2     19.9  ± 2.1     19.9  ± 2.1  
Age, Customized [1]
[units: participants]
     
Between 15 and 26 years     6087     6080     12167  
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
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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 ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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