NCT06220747

Effectiveness of HPV Vaccine Among Adolescents and Reproductive Women

Effectiveness of Single Dose or Two Doses of HPV Vaccine Among Adolescents and Reproductive Women: A Test-negative Control Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 760 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: Female
• Age: 12 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To assess the effectiveness of HPV vaccine 2 doses or less to prevent HPV high risk infection among adolescents and adults. We conduct the test-negative control study including 12-45 women who interest to do a check-up pap smear. Cases were women who met the inclusion criteria and tested positive for HPV DNA, and controls were defined as women who met inclusion criteria but tested negative. For the proposed HPV VE study, we will enroll nine controls for each enrolled case. The participants will be interviewed about their demographics and vaccine histories. Potential confounders data will be collected by interview or self- report questionnaire. HPV DNA test will be done by urine or self-cervical sampling (optional). In case the participant has previous HPV test result within 1 year, the result will be recorded and analysed without repeating the test.

Conditions

• Hpv

Timeline

• Start date: 2024-03-29
• Primary completion: 2025-03-01
• Completion: 2025-06-01
• First posted: 2024-01-24
• Last updated: 2024-10-09

Locations

2 sites across 1 country: Thailand