Status:
COMPLETED
Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women
Lead Sponsor:
GlaxoSmithKline
Conditions:
Papillomavirus Type 16/18 Infection
Cervical Intraepithelial Neoplasia
Eligibility:
FEMALE
10-25 years
Phase:
PHASE3
Brief Summary
The study will be extended for subjects who received all three doses of vaccine in Finland, Denmark and Estonia to determine long-term safety and immunogenicity of the HPV-16/18 vaccine. Human Papillo...
Detailed Description
Approximately 750 study subjects received different lots of the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule. The Protocol Posting has been updated in order to comply ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- A female who enrolled in the HPV-012 (NCT00337818) study in Denmark, Estonia and Finland, received three doses of vaccine and completed Visit 4 (Month 7).
- Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative (LAR) and, in addition, the subject must sign and personally date a written informed assent).
- Exclusion criteria
- Use of any investigational or non-registered product (drug or vaccine) 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 (pharmaceutical product or device).
- Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
- Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
770 Patients enrolled
Trial Details
Trial ID
NCT00337818
Start Date
June 1 2006
End Date
January 1 2009
Last Update
May 30 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Tallinn, Estonia, 1162