Study of Human Papillomavirus (HPV) 16 Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females (V501-005)(COMPLETED)
|Study Design:||Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Prevention|
HPV 16 Infection
Biological: Comparator: HPV 16 L1 Vaccine
Biological: Comparator: Placebo
|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.|
|HPV 16 L1 VLP (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 HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48.
|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.
|Total||Total of all reporting groups|
|HPV 16 L1 VLP (Group 1)||Placebo (Group 2)||Total|
Number of Participants
Mean ( Full Range )
( 16 to 25 )
( 16 to 23 )
( 16 to 25 )
|1. Primary:||Incidence of Persistent HPV 16 Infection [ Time Frame: Through Month 48 ]|
|2. Primary:||Incidence of HPV 16-related CIN1, CIN2 or C1N3 [ Time Frame: Through Month 48 ]|
|3. Primary:||Serum Anti-HPV 16 Geometric Mean Titers [ Time Frame: Month 7 ]|
|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:
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|
|Of note, the number of subjects reported in the results posting is slightly different than that specified in the publication by Koutsky, et al (2002). The data provided here is based on final data.|
Results Point of Contact:
Organization: Merck Sharp & Dohme Corp.
Publications automatically indexed to this study:
|Responsible Party:||Merck Sharp & Dohme Corp.|
|ClinicalTrials.gov Identifier:||NCT00365378 History of Changes|
|Other Study ID Numbers:||V501-005, 2006_515|
|Study First Received:||August 16, 2006|
|Results First Received:||March 22, 2010|
|Last Updated:||November 4, 2013|
|Health Authority:||United States: Food and Drug Administration