Complementary Testing to Further Evaluate the Immunogenicity of a GSK Biologicals' HPV Vaccine (580299) in Healthy Female Subjects Aged Over 26 Years Enrolled in Study 104820.
26 Years
N/A
Female
Human Papillomavirus (HPV) Infection, Papillomavirus Vaccines, Cervical Neoplasia
Trial Information
Complementary Testing to Further Evaluate the Immunogenicity of a GSK Biologicals' HPV Vaccine (580299) in Healthy Female Subjects Aged Over 26 Years Enrolled in Study 104820.
Inclusion Criteria:
- 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 Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Number of Cytokine-positive CD4/CD8 Cells Per Million in Tests Producing at Least 2 Different Cytokines
Outcome Description:
The geometric mean and 95% confidence interval of the number of Human Papilloma Virus type 16 (HPV-16) and HPV-18 specific CD4 and CD8 cells producing at least 2 different cytokines is reported per million of CD4 or CD8 T-cells, respectively.
Outcome Time Frame:
At Month 12 and Month 18 after first vaccination
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
109801
NCT ID:
NCT00456807
Start Date:
April 2007
Completion Date:
January 2008
Related Keywords:
- Human Papillomavirus (HPV) Infection
- Papillomavirus Vaccines
- Cervical Neoplasia
- Human Papillomavirus
- Neoplasms
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