An observational study in Hpv, sponsored by Mahidol University. Completed at 2 sites in Thailand. Open to female participants aged 12 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Mahidol University · Observational
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.
505 studies on the registry are indexed under Papillomavirus Infections; 128 are open to participants now.
This study's enrollment of 760 is above the median of 400 across 151 observational studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →Mahidol University is the lead sponsor of 744 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
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.
Time frame: 1 visit (1 day)
Ran from Mar 2024 to primary completion in Oct 2024, 7 months.
Of 57 non-industry observational studies under Papillomavirus Infections, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 90. This study's 7 months is below that.
Counting every sponsor, half of 69 studies reached it within 46 months; a quarter within 21 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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