NCT06220747 Effectiveness of HPV Vaccine Among Adolescents and Reproductive Women
| NCT ID | NCT06220747 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mahidol University |
| Condition | Hpv |
| Study Type | OBSERVATIONAL |
| Enrollment | 760 participants |
| Start Date | 2024-03-29 |
| Primary Completion | 2025-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 760 participants in total. It began in 2024-03-29 with a primary completion date of 2025-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Punnee Pitisuttithum, Prof.
STUDY CHAIR
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
Frequently Asked Questions
Who can join the NCT06220747 clinical trial?
This trial is open to female participants only, aged 12 Years or older, up to 45 Years, studying Hpv. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06220747 currently recruiting?
Yes, NCT06220747 is actively recruiting participants. Contact the research team at supitcha.kam@mahidol.edu for enrollment information.
Where is the NCT06220747 trial being conducted?
This trial is being conducted at Bangkok, Thailand, Bangkok, Thailand.
Who is sponsoring the NCT06220747 clinical trial?
NCT06220747 is sponsored by Mahidol University. The principal investigator is Punnee Pitisuttithum, Prof. at Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University. The trial plans to enroll 760 participants.