HpvNCT06220747
Effectiveness of HPV Vaccine Among Adolescents and Reproductive Women
An observational study of Hpv, run by Mahidol University at 2 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hpv
- How many people
- 760 participants
- Where
- 2 sitesThailand
- Study dates
- 29 Mar 2024to 31 Oct 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Target populations are any women aged 12-45-year-old who interest this project. For the proposed HPV VE study, we will enroll nine controls for each enrolled case. The participants will selection based on their outcome, not based on exposure. Cases were women who met the inclusion criteria and tested positive for HPV DNA (self-cervical swab/ urine sample: positive), and controls were defined as women who met inclusion criteria but HPV DNA tested negative.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Thailand2 sites
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
Bangkok, Select..., 10400
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, 420/6 Ratchawithi Road, Ratchathewi,
Bangkok, 10400
About this study
Official title: Effectiveness of Single Dose or Two Doses of HPV Vaccine Among Adolescents and Reproductive Women: A Test-negative Control Study
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
- Hpv
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| women aged 12-45 years old | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The real world effectiveness of HPV vaccine 2 doses or less to prevent HPV high risk infection among women aged 12-45
Estimation of overall vaccine effectiveness For the planned analyses, the log odds of disease for individuals in matched sets will be modelled using the following conditional logistic model:Model 1 : Log (oddcase) = α¬i + β e(HPV_vaccination) + β1(cov_1) +β2(cov_2) + ... + βk(cov_k)where αi is the stratum-specific constant term for each matched set, βe is the parameter coefficient for the exposure of interest (receipt of HPV vaccine), and β1 through βk are the parameter coefficients for each covariate included in the model to control for confounding. Our modelling strategy will be to create models that always contain the exposure variable of interest (receipt of HPV vaccine) and additional covariates as needed.
Measured: 1 visit (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start29 Mar 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HpvStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 760 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council of Thailand
- Responsible party
- Principal investigator, Punnee Pitisuttithum, Mahidol University
- Investigators
- Punnee Pitisuttithum, Prof., Study chair, Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220747
- Sponsor's protocol ID
- NRCT9-3
- Status last verified
- Oct 2026
- First submitted
- 15 Jan 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No