Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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: September 26, 2016
Last verified: September 2016
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
  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.
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 
Overall Participants Analyzed 
[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 
[1] Age for study subjects was recorded at the time of subject entry into the base study.
Gender 
[Units: Participants]
     
Female   6087   6080   12167 
Male   0   0   0 
Race/Ethnicity [1] 
[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] 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 ]

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
  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