Effectiveness of HPV Vaccine Among Adolescents and Reproductive Women

Last updated: October 7, 2024
Sponsor: Mahidol University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06220747
NRCT9-3
  • Ages 12-45
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women aged 12-45 who willing to do HPV test check-up.

  • Subject has provided written informed consent prior to performance of anystudy-specific procedures and is willing and has means to be contacted and tocontact the investigator during the study.

  • Based on clinical judgment, the participant with underlying chronic disease who hasstable and well-controlled medical conditions.

Exclusion

Exclusion Criteria:

  • Participant with history of total hysterectomy and loop electrosurgical excisionprocedure.

  • Participant who received 3 doses HPV vaccine.

  • Any condition that might confound the interpretation of vaccine effectiveness byinvestigator

Study Design

Total Participants: 760
Study Start date:
March 29, 2024
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

    Bangkok, Select... 10400
    Thailand

    Active - Recruiting

  • Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, 420/6 Ratchawithi Road, Ratchathewi,

    Bangkok, 10400
    Thailand

    Active - Recruiting

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