Status:
COMPLETED
Complementary Testing to Evaluate Immunogenicity of Human Papillomavirus (HPV) Vaccine (580299) in Healthy Female Subjects Aged >/= 26 Years
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Papillomavirus
Eligibility:
FEMALE
26+ years
Phase:
PHASE3
Brief Summary
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb...
Eligibility Criteria
Inclusion
- A female enrolled in study 104820 and who received three doses of study vaccine/control.
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- Written informed consent obtained from the subject prior to enrolment in this ancillary study.
Exclusion
- Pregnancy.
- Administration of any HPV vaccine other than that foreseen by the study protocol.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine since study start.
- Chronic administration of immunosuppressants or other immune-modifying drugs since study start.
- Administration of immunoglobulins and/or any blood products within 90 days preceding a blood sampling.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00456807
Start Date
April 1 2007
End Date
January 1 2008
Last Update
December 16 2016
Active Locations (2)
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1
GSK Investigational Site
Amsterdam, Netherlands, 1007 MB
2
GSK Investigational Site
Delft, Netherlands, 2625 AD