cervical cancer => study is conducted in healthy female
Conditions
Sponsors
GlaxoSmithKline SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Female subjects 15 – 25 years of age who have a negative urine pregnancy test at the time of the first vaccination. (If they are of childbearing potential at the time of study entry, they must be abstinent or must be using an effective method of birth control.) - No more than 6 lifetime sexual partners prior enolment - Subject must have intact cervix 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: - Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy - Planning to become pregnant or planning to discontinue contraceptive during he first 9 months of the study. - Previous administration of monophosphoryl lipid A (MPL) or AS04 adjuvant (no vaccines currently licensed contain these). - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. - Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. - History of vaccination against Hepatitis A or a known clinical history of Hepatitis A disease (no laboratory testing required). - Previous vaccination against human papillomavirus (HPV). - History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test. - Planned administration/administration of a vaccine (except Meningococcal, Hepatitis B, Inactivated Influenza, and Diptheria/Tetanus) not foreseen by the study protocol within 30 days before and after the administration of each dose of vaccine. - Planned administration/administration of routine vaccines such as Meningococcal, Hepatitis B, Inactivated Influenza, and Diphtheria/Tetanus and/or Diphtheria/Tetanus-containing vaccine within 8 days before and 30 days after the administration of each vaccine. - Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination (no laboratory testing required). - History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines, e.g. MPL, AS04, Hepatitis A antigen, 2-phenoxyethanol or neomycin. - Hypersensitivity to latex (found in syringe-tip cap and plunger). - Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests. - History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes, or autoimmune disease. - Received immunoglobulins and/or blood product within 90 days preceding enrollment. Enrollment will be deferred until the subject is outside of specified window. - Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Enrollment will be deferred until condition is resolved. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral/axillary temperature <37.5°C (99.5°F). - Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a pelvic exam cannot be performed. Enrollment will be deferred until condition is resolved according to investigators medical judgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: primary objectives: - To demonstrate efficacy of the candidate vaccine compared with control in the prevention of histopathologically confirmed CIN2+ associated with HPV-16 or HPV-18 cervical infection detected in the preceding cytological specimen (by PCR) post dose 3 (after Month 6 to Month 48) in adolescent and young adult women who are negative for HPV DNA (by PCR) at Months 0 and 6 for the corresponding HPV type The principal analysis will be performed on subjects who are seronegative (by ELISA) prior to vaccination for the corresponding HPV type present in the sample. ;Secondary Objective: For all serostratified secondary and exploratory efficacy analyses, the principal analysis will be performed on subjects who are seronegative (by ELISA) prior to vaccination for the corresponding HPV type present in the sample. -safety of HPV vaccine throughout study period -efficacy of the candidate vaccine compared with control in the prevention of histopathologically confirmed CIN2+ associated with the following oncogenic HPV types (or combination of types) detected within the lesional component of the cervical tissue specimen (by PCR): HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 -•efficacy of the candidate vaccine compared with control in the prevention of histopathologically confirmed CIN1+ associated with the following oncogenic HPV types (or combination of types) detected within the lesional component of the cervical tissue specimen (by PCR): HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 (please refer to protocol);Primary end point(s): Histopathological - Histopathologically confirmed CIN2+ associated with HPV-16 or HPV-18 cervical infection detected in the preceding cytological specimen (by PCR). CIN2+ (cervical intraepithelial neoplasia) is defined as CIN2, CIN3, adenocarcinoma in-situ (AIS), and invasive cervical cancer. Preceding cytological specimen is defined as the last cervical cytology specimen collected | — |
Countries
Spain
Outcome results
None listed