UnknownNot Applicable

The Prospective Cohort Study to Evaluate the Preventive Efficacy of HPV Vaccine in Japanese Women Aged 27-45 Years

2,800 participantsStarted 2019-08-01

Plain-language summary

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.

Who can participate

Age range27 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

The rate of the persistent infection

Timeframe: 48months

Trial details

NCT IDNCT04022148

SponsorUniversity of Fukui

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-12-31

Contact for this trial

Tetsuji Kurokawa, AP

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

View on ClinicalTrials.gov More Cancer of Cervix trials