Unique ID issued by UMIN | UMIN000005656 |
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Receipt number | R000006665 |
Scientific Title | preventive effect for reinfection of human papillomavirus (HPV) 16/18 against cervical intraepithelial neoplasia (CIN) 1 |
Date of disclosure of the study information | 2011/06/30 |
Last modified on | 2011/05/26 11:01:44 |
preventive effect for reinfection of human papillomavirus (HPV) 16/18 against cervical intraepithelial neoplasia (CIN) 1
preventive effect for reinfection of human papillomavirus (HPV) 16/18 against cervical intraepithelial neoplasia (CIN) 1
preventive effect for reinfection of human papillomavirus (HPV) 16/18 against cervical intraepithelial neoplasia (CIN) 1
preventive effect for reinfection of human papillomavirus (HPV) 16/18 against cervical intraepithelial neoplasia (CIN) 1
Japan |
patient with cervical intraepithelial neoplasia (CIN) 1
Obstetrics and Gynecology |
Malignancy
NO
HPV typing test for female with 20s and 30s who have some experience in diagnosis of low-grade squamous intraepithelial lesion by tissue diagnosis, check the situation of infection with or without HPV 16/18, and also demonstrate the HPV vaccine efficacy to protect against 6-month persistent cervical infections, effect for reinfection by HPV typing test in one/ two year after vaccination.
Safety,Efficacy
situation of infection with or without HPV 16/18
situation in one/ two year of both group
Interventional
Parallel
Non-randomized
Open -no one is blinded
No treatment
2
Prevention
Vaccine |
HPV typing test and receive Cervarix
HPV typing test and not-receive Cervarix
20 | years-old | <= |
40 | years-old | > |
Female
1.Sex: female
2.Age: and above 20, under 40
3.patients who have a diagnosis of low-grade squamous intraepithelial lesion (CIN 1) by tissue diagnosis
1.obvious progression of squamous intraepithelial lesion
2.diagnosis of cervical cancer in past times
3.diagnosis of above middle-grade squamous intraepithelial lesion in past times
4.obvious fever
5.obvious any severe acute disease
6.history of hypersensitivity to any ingredient of Cervarix
7.during pregnancy
8.during lactation
9.receive live vaccine within 27 days
10.receive inactivated vaccine within 6 days
200
1st name | |
Middle name | |
Last name | Hiroshi Tsujioka |
Fukuoka University Hospital
Department of gynecology
7-45-1 nanakuma, jonan-ku, fukuoka, Japan
1st name | |
Middle name | |
Last name |
Fukuoka University Hospital
Department of gynecology
7-45-1 nanakuma, jonan-ku, fukuoka, Japan
Department of gynecology, Fukuoka University Hospital
None
Self funding
NO
2011 | Year | 06 | Month | 30 | Day |
Unpublished
Open public recruiting
2011 | Year | 02 | Month | 08 | Day |
2011 | Year | 08 | Month | 01 | Day |
2011 | Year | 05 | Month | 26 | Day |
2011 | Year | 05 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006665
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