臨床研究等提出・公開システム

Date of registration	Aug. 21, 2019
Last modified on	April. 27, 2026
Trial ID	jRCTs051190039

Scientific Title	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)
Public Title	HAKUOH Study (HAKUOH Study)

Contact for Scientific Queries	Name	Orisaka Makoto
	Affiliation	University of Fukui Hospital
	Address	23-3Matsuoka Shimoaiduki,Eiheiji-cho,Yoshida-gun,Fukui
	Telephone	+81-776-61-8392
	E-mail	orisaka@u-fukui.ac.jp
Contact for Public Queries	Name	Shinagawa Akiko
	Affiliation	University of Fukui Hospital
	Address	23-3Matsuoka Shimoaiduki,Eiheiji-cho,Yoshida-gun,Fukui
	Telephone	+81-776-61-8392
	E-mail	hakuoh@ml.u-fukui.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Aug. 21, 2019
Target sample size		2100
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion 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 >Pregnant women >Undergo treatment or the follow-up evaluation for CIN within the previous 12 months >Previously administered HPV vaccine
	Age Minimum	27age old over
	Age Maximum	45age old under
	Gender	Female
Health Condition(s) or Problem(s) Studied		Uterine cervical cancer
Intervention(s)		arm A:vaccine group 3 times(0 month, 2 month, 6 month) arm B:non-vaccine group
Health Condition(s) Keyword		HPV infection
Primary Outcome(s)		Persistent inflectional rate
Secondary Outcome(s)		Vaccinationrate by age group,Persistent inflectional rate by age group

Source of Monetary Support / Secondary Sponsor	Merck Sharp & Dohme Corp.

Name of Certified Review Board	Certified Review Board, University of Fukui
Address	23-3Matsuoka Shimoaiduki,Eiheiji-cho,Yoshida-gun, Fukui
Telephone	+81-776-61-8640
E-Mail	rinrisys@ml.u-fukui.ac.jp
Approval Status	Approval
Date of approval	May. 20, 2019

Plan to share IPD	No
Plan description	No

Countries of Recruitment（Except Japan）	None

History of Changes

No	Publication date
17	April. 27, 2026	(this page)	Changes
16	Aug. 22, 2025	Detail	Changes
15	May. 01, 2025	Detail	Changes
14	April. 28, 2025	Detail	Changes
13	April. 15, 2025	Detail	Changes
12	April. 26, 2023	Detail	Changes
11	April. 06, 2023	Detail	Changes
10	April. 05, 2023	Detail	Changes
9	Jan. 18, 2023	Detail	Changes
8	Oct. 19, 2022	Detail	Changes
7	Sept. 16, 2022	Detail	Changes
6	Oct. 27, 2021	Detail	Changes
5	July. 19, 2021	Detail	Changes
4	Nov. 11, 2020	Detail	Changes
3	Oct. 22, 2020	Detail	Changes
2	Dec. 02, 2019	Detail	Changes
1	Aug. 21, 2019	Detail

List of change history