A long-term, open follow-up of the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 VLP/AS04 vaccine in healthy female subjects up to 10 years after administration of the first vaccine dose in study HPV-013. - HPV-025 EXT 013
- Conditions
- For the prevention of high-grade cervical intraepithelial neoplasia (CIN grades 2 and 3) and cervical cancer causally related to human papillomavirus (HPV) types 16 and 18.
- Registration Number
- EUCTR2008-000369-44-DE
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 600
• 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 (e.g. return for follow-up visits) should be enrolled in the study.
• A female enrolled in the immunogenicity subset of study HPV-013, who received three doses of HPV-16/18 VLP/AS04 vaccine and participated in the long-term follow-up study Ext HPV-013.
• Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from a parent or LAR and, in addition, the subject should sign a written informed assent form.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• 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).
• 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 three doses of HPV-16/-18 vaccine administered in study HPV-013.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs occurring within the three months preceding study entry. (For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.)
• Administration of immunoglobulins and/or any blood products within the three months preceding study entry.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the long-term immunogenicity of the HPV-16/18 vaccine by enzyme-linked immunosorbent assay (ELISA).;Secondary Objective: • To evaluate the long-term safety of the HPV-16/18 vaccine.<br>• To evaluate the immune responses to the HPV-16/18 vaccine (as determined by anti-HPV-16/18 ELISA) in subjects in this study versus the immune responses to the HPV-16/18 vaccine in young women in the efficacy studies HPV-001/HPV-007/HPV-023 at equivalent time points.<br>• To evaluate the immune responses to the HPV-16/18 vaccine (as determined by anti-HPV-16/18 ELISA) in subjects in this study versus the immune responses elicited after natural infection.;Primary end point(s): Anti-HPV-16/18 antibody titres and seroconversion rates (ELISA).
- Secondary Outcome Measures
Name Time Method