Clinical trial · Observational
The Prospective Cohort Study to Evaluate the Preventive Efficacy of HPV Vaccine in Japanese Women Aged 27-45 Years
A Nonrandomized, Non-double Blinded Prospective Cohort Study to Evaluate the Preventive Efficacy of Quadrivalent HPV6/11/16/18 Vaccine for the Persistent Infection of HPV16 Genotype or HPV18 Genotype in Japanese Women Aged 27-45 Years.
NCT04022148CI-TRIAL-00039593unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A nonrandomized, non-double blinded prospective cohort study to evaluate the preventive efficacy of quadrivalent HPV6/11/16/18 vaccine for the persistent infection of HPV16 genotype or HPV18 genotype in Japanese women aged 27-45 years.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Cervix | Malignant Cervical Neoplasm | ALIAS | 0.90 |
| Vaccinia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gardasil | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The rate of the persistent infection
- timeFrame
- 48months
- description
- Persistent infection is the cases that the cells from women with HPV16/18 genotype overexpressed p16 and Ki67.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 27 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Women with normal cytology results confirmed in cervical cancer screening programs from May 2019 to March 2020 * 27-45 years-old * Intact uterus * Willing to undergo the HPV-DNA test (cobas4800) within 12 months Exclusion Criteria: * Pregnant women * Undergo treatment or the follow-up evaluation for CIN within the previous 12 months * Previously administered HPV vaccine
References
Publications (1)
- DERIVEDKurokawa T, Yamamoto M, Onuma T, Tsuyoshi H, Shinagawa A, Chino Y, Yoshida Y. The study protocol of the evaluation for the preventive efficacy of the HPV vaccine for persistent HPV16/18 infection in Japanese adult women: the HAKUOH study. BMC Cancer. 2020 Nov 3;20(1):1056. doi: 10.1186/s12885-020-07563-0. PMID 33143690