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
|Condition or disease||Intervention/treatment||Phase|
|HPV 16 Infection||Biological: Comparator: HPV 16 L1 Vaccine Biological: Comparator: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2409 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Study of Pilot Manufacturing Lot of HPV 16 Virus-Like Particle (VLP) Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females|
|Study Start Date :||September 1999|
|Actual Primary Completion Date :||March 2004|
|Actual Study Completion Date :||July 2009|
HPV 16 L1 VLP vaccine
Biological: Comparator: HPV 16 L1 Vaccine
A 0.5 intramuscular injection given at Day 1, Month 2, and Month 6
Other Name: V501
Placebo Comparator: 2
Biological: Comparator: Placebo
A 0.5 intramuscular placebo injection given at Day 1, Month 2, and Month 6
- Incidence of Persistent HPV 16 Infection [ Time Frame: Through Month 48 ]Cases of persistent infection were those with detection of HPV 16 by PCR (Polymerase chain reaction) on at least 2 consecutive visits at least 4 months apart; or detection of HPV 16 in a cervical biopsy specimen showing pathologic evidence of CIN1 (Cervical intraepithelial neoplasia), CIN2 or CIN3 together with HPV 16 detected at the visit immediately before or after the biopsy; or detection of HPV 16 on a subject's last visit.
- Incidence of HPV 16-related CIN1, CIN2 or C1N3 [ Time Frame: Through Month 48 ]Cases of HPV 16-related CIN1, CIN2 or CIN3 are those with detection of HPV 16 in a cervical biopsy specimen showing pathologic evidence of CIN1, CIN2 or CIN3 together with HPV 16 detected at the visit immediately before or after the biopsy.
- Serum Anti-HPV 16 Geometric Mean Titers [ Time Frame: Month 7 ]The limit of detection of the assay was 6 mMU/ml. Samples with titer below the limit of detection were assigned a value of 3 for calculation of GMT and confidence interval. GMTs and confidence limits below the limit of detection are shown as "6.0".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00365378
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|