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.
Conditions
Interventions
Trade Name: Cervarix
Product Name: Cervarix™
Product Code: HPV-16/18 L1 VLP AS04 vaccine
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Human Papillomavirus type 16 L1 protein
Othe
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. • 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. • 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). | — |
Countries
Germany
Outcome results
None listed