Effectiveness of HPV Vaccine Among Adolescents and Reproductive Women

Mahidol University

Status: Enrolling

Conditions: Hpv

Study type: Observational

Funder types: Other

Identifiers

NCT06220747

NRCT9-3

Details and patient eligibility

About

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.

Enrollment: 760 estimated patients

Sex: Female

Ages: 12 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women aged 12-45 who willing to do HPV test check-up.
• Subject has provided written informed consent prior to performance of any study-specific procedures and is willing and has means to be contacted and to contact the investigator during the study.
• Based on clinical judgment, the participant with underlying chronic disease who has stable and well-controlled medical conditions.

Exclusion criteria

• Participant with history of total hysterectomy and loop electrosurgical excision procedure.
• Participant who received 3 doses HPV vaccine.
• Any condition that might confound the interpretation of vaccine effectiveness by investigator

Trial design

760 participants in 1 patient group

women aged 12-45 years old