The Prospective Cohort Study to Evaluate the Preventive Efficacy of HPV Vaccine in Japanese Women Aged 27-45 Years
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ClinicalTrials.gov Identifier: NCT04022148
Recruitment Status : Unknown
Verified July 2019 by Yoshio Yoshida, University of Fukui. Recruitment status was: Not yet recruiting
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.
Condition or disease
Cancer of CervixVaccinia
A series of evidence for HPV vaccines has demonstrated the efficacy in young women (Aged less than 26) across the globe. In contrast, limited evidence are available for the efficacy of the quadrivalent HPV6/11/16/18 vaccine in adult women (Aged 27+). Most importantly, evidence for Japanese adult women is not available to date. Nevertheless, , we hypothesize that the quadrivalent HPV6/11/16/18 vaccine demonstrate the efficacy also in Japanese adult women. The outcome from this trial will be the first local evidence, which brings a considerable impact in OB/GY academia where local evidence is weighed heavily compared with global evidence - serves as a strong basis to support catch up program of HPV vaccines for young adults. As a consequence, we believe this study will develop a local supportive evidence for prevention of HPV infection by an HPV vaccine in young adults, which results in substantial public health improvement through prevention of HPV infection in Japan where active recommendation is halted long time.
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.
Estimated Study Start Date :
August 1, 2019
Estimated Primary Completion Date :
December 31, 2020
Estimated Study Completion Date :
December 31, 2020
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Layout table for eligibility information
Ages Eligible for Study:
27 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Japanese adult women (aged 27-45 years) undergo the cervical cancer screening.
Women with normal cytology results confirmed in cervical cancer screening programs from May 2019 to March 2020
Willing to undergo the HPV-DNA test (cobas4800) within 12 months
Undergo treatment or the follow-up evaluation for CIN within the previous 12 months