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

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 12
Maximum Age: 45
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Thailand
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
RECRUITING
Bangkok
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, 420/6 Ratchawithi Road, Ratchathewi,
RECRUITING
Bangkok
Contact Information
Primary
Supitcha Kamolratanakul, Asst.Prof.
supitcha.kam@mahidol.edu
66 81 699 6660
Time Frame
Start Date: 2024-03-29
Estimated Completion Date: 2025-06
Participants
Target number of participants: 760
Treatments
women aged 12-45 years old
Related Therapeutic Areas
Sponsors
Collaborators: National Research Council of Thailand
Leads: Mahidol University

This content was sourced from clinicaltrials.gov