Status:
UNKNOWN
The Prospective Cohort Study to Evaluate the Preventive Efficacy of HPV Vaccine in Japanese Women Aged 27-45 Years
Lead Sponsor:
University of Fukui
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Cancer of Cervix
Vaccinia
Eligibility:
FEMALE
27-45 years
Brief 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 ...
Detailed Description
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 quadrivalen...
Eligibility Criteria
Inclusion
- 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
- Pregnant women
- Undergo treatment or the follow-up evaluation for CIN within the previous 12 months
- Previously administered HPV vaccine
Key Trial Info
Start Date :
August 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
2800 Patients enrolled
Trial Details
Trial ID
NCT04022148
Start Date
August 1 2019
End Date
December 31 2020
Last Update
July 19 2019
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