Clinical trial NCT00456807: Complementary Testing to Evaluate Immunogenicity of Human Papillomavirus (HPV) Vaccine (580299) in Healthy Female Subjects Aged >/= 26 Years
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Papillomavirus
Keywords: Human Papillomavirus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-04-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 26
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. This study will supplement an ongoing study evaluating the safety, efficacy and immunogenicity of the vaccine in women aged 26 years and above. This study will therefore assess additional immunogenicity parameters of the vaccine in women from selected investigative sites.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Cytokine-positive CD4/CD8 Cells Per Million in Tests Producing at Least 2 Different Cytokines
timeFrame: At Month 12 and Month 18 after first vaccination
measure: Number of B-cells Per Million Showing a Specific Memory Response for HPV-16 and HPV-18
timeFrame: At Month 12 and Month 18 after first vaccination
measure: Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above Pre-defined Cut-off Values
timeFrame: At Month 12 and Month 18 after first vaccination
measure: Titers of Anti-HPV-16 and Anti-HPV-18 Antibodies
timeFrame: At Month 12 and Month 18 after first vaccination
measure: Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) Immunoglobulin G (IgG) Antibodies
timeFrame: At Month 12 and Month 18 after first vaccination
measure: Correlation of Anti-HPV-16 and Anti-HPV-18 Antibodies in Serum and in Cervical Secretion (CVS) Samples
timeFrame: At Month 12 and Month 18 after first vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: GSK Investigational Site
city: Delft
country: Netherlands
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: