Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00365378 | Study of Human Papillomavirus (HPV) 16 Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females (V501-005) | PHASE2 | COMPLETED | 2,409 | — | — | Sep 1, 1999 | Jul 1, 2009 | Oct 23, 2015 | - | — |
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.
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.
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".
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | HPV 16 L1 VLP vaccine |
| 2 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Comparator: HPV 16 L1 Vaccine | BIOLOGICAL | A 0.5 intramuscular injection given at Day 1, Month 2, and Month 6 |
| Comparator: Placebo | BIOLOGICAL | A 0.5 intramuscular placebo injection given at Day 1, Month 2, and Month 6 |
Inclusion Criteria: * Healthy, unmarried females age 16 to 23 years with intact uteri * Not pregnant at enrollment * Agreed to use effective contraception through Month 7 of the study * A lifetime history of 0 to 5 male partners with whom the subjects engaged in at least one episode of insertive in...