HAKUOH Study

A nonrandomized, non-double blinded prospective cohort study to evaluate the preventive efficacy of quadrivalent HPV6/11/16/18 vaccine (Gardasil) for the persistent infection of HPV16 genotype or HPV18 genotype in Japanese women aged 27-45 years. - HAKUOH Study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051190039

Enrollment

2100

Registered

2019-08-21

Start date

2019-08-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine cervical cancer HPV infection

Interventions

arm A:vaccine group 3 times(0 month, 2 month, 6 month) arm B:non-vaccine group

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: Exclusion criteria >Pregnant women >Undergo treatment or the follow-up evaluation for CIN within the previous 12 months >Previously administered HPV vaccine

Design outcomes

Primary

Measure	Time frame
Persistent inflectional rate	—

Secondary

Measure	Time frame
Vaccinationrate by age group,Persistent inflectional rate by age group	—

Contacts

Public ContactAkiko Shinagawa

University of Fukui Hospital

hakuoh@ml.u-fukui.ac.jp+81-776-61-8392

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026