Status:
COMPLETED
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Papillomavirus
Eligibility:
FEMALE
20-60 years
Phase:
PHASE3
Brief Summary
Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the GSK ...
Detailed Description
Subjects were aged 15-55 years at the time of entry into the primary study (NCT00196937). No vaccine was administered in this extension study. Results on outcome measures describing analyses on other...
Eligibility Criteria
Inclusion
- Subjects who the investigator believed that they could and would comply with the requirements of the protocol.
- A female who had been enrolled in NCT00196937 study and received three doses of HPV-16/18 vaccine.
- Written informed consent obtained from the subject.
Exclusion
- Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
- Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
- 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).
- Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
- Administration or planned administration of any HPV vaccine, other than the three doses of HPV-16/18 vaccine administered in NCT00196937 study.
Key Trial Info
Start Date :
September 22 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2015
Estimated Enrollment :
525 Patients enrolled
Trial Details
Trial ID
NCT00947115
Start Date
September 22 2009
End Date
February 3 2015
Last Update
October 30 2020
Active Locations (6)
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1
GSK Investigational Site
Munich, Bavaria, Germany, 80637
2
GSK Investigational Site
Würzburg, Bavaria, Germany, 97070
3
GSK Investigational Site
Berlin, Germany, 12200
4
GSK Investigational Site
Bydgoszcz, Poland, 85-079