For active immunization of women from the age of 10 years onwards to prevent cervical cancer (squamous-cell carcinoma and adenocarcinoma) by protecting against incident and persistent infections, cytological abnormalities including atypical squamous cells of undetermined significance (ASC US) and cervical intraepithelial neoplasia (CIN), CIN1 and pre-cancerous lesions (CIN2 and CIN3), caused by oncogenic human papillomavirus (HPV) types 16 and 18. MedDRA version: 15.1 Level: LLT Classification
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects who the investigator believes that they can and will comply with the requirements of the protocol. • A female who enrolled in study HPV-014 and received three doses of HPV-16/18 vaccine. • Written informed consent obtained from the subject. Are the trial subjects under 18? no 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 647 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period. • Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling. For corticosteroids, this will mean prednisone, >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. • 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). • Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling. • Administration or planned administration of any HPV vaccine, other than the three doses of HPV-16/18 vaccine administered in study HPV 014.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term immunogenicity of the HPV 16/18 vaccine in serum from all subjects by enzyme-linked immunosorbent assay (ELISA) at Years 5, 6, 7, 8, 9 and 10.;Secondary Objective: In serum samples collected at Years 5, 6, 7, 8, 9 and 10: • To compare the immune responses to the HPV-16/18 vaccine (as determined by anti-HPV-16/18 antibodies assessed by ELISA) to levels in efficacy studies HPV 001, HPV-007 and HPV-023 at equivalent time points. • To compare the immune responses to the HPV-16/18 vaccine (as determined by anti-HPV-16/18 antibodies assessed by ELISA) to levels after natural infection from study HPV-008. • To evaluate total immunoglobulin G (IgG). In cervico-vaginal secretion (CVS) samples collected from subjects who volunteer at Years 5, 6, 7, 8, 9 and 10: • To evaluate anti-HPV-16 and anti-HPV-18 antibody levels. • To compare anti-HPV-16 and anti-HPV-18 antibody levels in CVS samples with antibody levels in serum samples. • To evaluate total IgG. • To evaluate the long-term safety of the HPV-16/18 vaccine up to approximately 10 years after administration of the first vaccine dose.;Primary end point(s): • Evaluation of immune responses to components of the vaccine in serum of all subjects at Years 5, 6, 7, 8, 9 and 10: - Anti-HPV-16 and anti-HPV-18 antibody titres by ELISA, - Seroconversion rates by ELISA.;Timepoint(s) of evaluation of this end point: At Years 5, 6, 7, 8, 9 and 10. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Evaluation of immune responses to components of the vaccine in Cervico-vaginal Secretions (CVS) samples of subjects who volunteer at Years 5, 6, 7, 8, 9 and 10 following first dose of HPV 16/18 L1 VLP AS04 vaccine: - Anti-HPV-16 and anti-HPV-18 antibody titres by ELISA, - Total IgG evaluation by ELISA. •Evaluation of immune responses to components of the vaccine in serum from efficacy studies (HPV-001/ HPV 007/HPV-023): - Anti-HPV-16 and anti-HPV-18 antibody titres by ELISA. •Evaluation of immune responses to components of the vaccine in serum elicited after natural infection (study HPV 008): - Anti-HPV-16 and anti-HPV-18 antibody titres by ELISA. •Evaluation of immune responses in serum from subjects who volunteer at Years 5, 6, 7, 8, 9 and 10 following first dose of HPV-16/18 L1 VLP AS04 vaccine: - Total IgG evaluation by ELISA. •Occurrence of vaccine-, study participation-, or GSK concomitant medication-related SAEs and fatal SAEs throughout the study period.;Timepoint(s) of evaluation of this end point: Immune responses: At Years 5, 6, 7, 8, 9 and 10. SAEs: Throughout the study period. | — |
Countries
Germany, Poland
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed