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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00128661 | Vaccine To Prevent Cervical Intraepithelial Neoplasia or Cervical Cancer in Younger Healthy Participants | PHASE3 | COMPLETED | 7,466 | — | — | Jun 30, 2004 | Dec 31, 2010 | Mar 8, 2019 | 1 | Costa Rica |
CIN2+ was defined as CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer. Preceding cervical cytology means the last cervical cytology specimen collected before the histopathology specimen was obtained. Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) by polymerase chain reaction (PCR) at Month 0 and Month 6 for the corresponding HPV-type.
| Arm | Type | Description |
|---|---|---|
| Cervarix Group | EXPERIMENTAL | Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm. |
| Havrix Group | ACTIVE_COMPARATOR | Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm. |
| Name | Type | Description |
|---|---|---|
| human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine | BIOLOGICAL | Three doses of Cervarix vaccine administered on a 0, 1, 6-month schedule |
| hepatitis A inactivated virus vaccine | BIOLOGICAL | Three doses of Havrix vaccine administered on a 0, 1, 6-month schedule |
DISEASE CHARACTERISTICS: •Healthy participants * Deemed to be in good general health by history and physical examination •Resident of Guanacaste Province of Costa Rica and surrounding areas * Must remain a resident for ≥ 6 months after the first study vaccination PATIENT CHARACTERISTICS: Age ...