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

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ClinicalTrials.gov Identifier: NCT00092521
Recruitment Status : Completed
First Posted : September 28, 2004
Results First Posted : November 20, 2009
Last Update Posted : September 25, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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

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
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 
Overall Participants Analyzed 
[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 
[1] Although the upper age limit for this study was 23 years old, four subjects aged 24 were randomized into the study.
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 


  Outcome Measures

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


  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
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  More Information