Status:
COMPLETED
Extension Study of the Efficacy of the GSK 580299 Vaccine in Japanese Women Vaccinated in the Primary NCT00316693 Study
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Papillomavirus
Eligibility:
FEMALE
20-25 years
Phase:
PHASE3
Brief Summary
This extension study is conducted to assess the efficacy of the GSK 580299 vaccine against cervical intraepithelial neoplasia (CIN) lesions, cervical cancer and cytological abnormalities associated wi...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol;
- Written informed consent obtained from the subject prior to enrolment in the extension study;
- A subject previously vaccinated in the NCT00316693 study.
- Subjects who showed, at the last NCT00316693 study visit (at Month 24) willingness to participate in this extension study.
Exclusion
- Use of any HPV vaccine other than the one administered in the NCT00316693 study;
- Use of any investigational or non-registered product other than the study vaccine since last NCT00316693 study visit, or planned use during the study period;
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product;
- Subjects who were diagnosed high grade or missing cytology at Month 0 in the NCT00316693 study;
- Pregnant females and females who were pregnant less than 3 months ago.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
752 Patients enrolled
Trial Details
Trial ID
NCT00929526
Start Date
June 1 2009
End Date
February 1 2011
Last Update
October 20 2016
Active Locations (13)
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1
GSK Investigational Site
Aomori, Japan, 036-8003
2
GSK Investigational Site
Fukui, Japan, 910-0858
3
GSK Investigational Site
Hiroshima, Japan, 733-0813
4
GSK Investigational Site
Hiroshima, Japan, 734-0036