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
Papillomavirus Vaccines
Eligibility:
FEMALE
15-24 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 5802...
Detailed Description
Subjects were aged 10-14 years at the time of entry into the primary study. No vaccine will be administered in this extension study. Results on outcome measures describing analyses on other studies a...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that they and/or their parents or legally acceptable representative (LAR) can and will comply with the requirements of the protocol should be enrolled in the study.
- A female enrolled in the immunogenicity subset of study 580299-013, who received three doses of HPV vaccine and participated in the extension study of 580299-013.
- Written informed assent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative of the subject.
Exclusion
- 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.
- Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
- Administration or planned administration of any HPV vaccine, other than the vaccine administered in study 580299-013.
- Chronic administration of immunosuppressants or other immune-modifying drugs occurring within the three months preceding study entry.
- Administration of immunoglobulins and/or any blood products occurring within the three months preceding study entry.
Key Trial Info
Start Date :
May 7 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2015
Estimated Enrollment :
632 Patients enrolled
Trial Details
Trial ID
NCT00877877
Start Date
May 7 2009
End Date
January 6 2015
Last Update
January 18 2020
Active Locations (26)
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1
GSK Investigational Site
Bogotá, Colombia
2
GSK Investigational Site
Deggingen, Baden-Wurttemberg, Germany, 73326
3
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, Germany, 77955
4
GSK Investigational Site
Kehl, Baden-Wurttemberg, Germany, 77694