Study of Human Papillomavirus (HPV) 16 Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females (V501-005)
|ClinicalTrials.gov Identifier: NCT00365378|
Recruitment Status : Completed
First Posted : August 17, 2006
Results First Posted : April 9, 2010
Last Update Posted : October 23, 2015
|Study Design:||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, 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.|
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|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|
Overall Participants Analyzed
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 ]|
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.|