Actively Recruiting

Age: 12Years - 45Years
FEMALE
Healthy Volunteers
NCT06220747

Effectiveness of HPV Vaccine Among Adolescents and Reproductive Women

Led by Mahidol University · Updated on 2024-10-09

760

Participants Needed

2

Research Sites

61 weeks

Total Duration

On this page

Sponsors

M

Mahidol University

Lead Sponsor

N

National Research Council of Thailand

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Effectiveness of HPV Vaccine Among Adolescents and Reproductive Women

Who Can Participate

Age: 12Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 12-45 who are willing to do an HPV test check-up.
  • Provided written informed consent before any study procedures.
  • Have stable and well-controlled chronic medical conditions as judged clinically.
Not Eligible

You will not qualify if you...

  • History of total hysterectomy or loop electrosurgical excision procedure.
  • Received three doses of HPV vaccine.
  • Any condition that may affect interpretation of vaccine effectiveness as determined by the investigator.

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Bangkok, Select..., Thailand, 10400

Actively Recruiting

2

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

Bangkok, Thailand, 10400

Actively Recruiting

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Research Team

S

Supitcha Kamolratanakul, Asst.Prof.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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