Cervarix is indicated in females from 10 years of age onwards for the prevention of persistent infection, premalignant cervical lesions and cervical cancer (squamous-cell carcinoma and adenocarcinoma) caused by oncogenic human papillomaviruses (HPV) types 16 and 18. In addition, Cervarix has shown efficacy against persistent infection caused by oncogenic HPV types other than HPV-16 and HPV-18. MedDRA version: 17.1 Level: LLT Classification code 10063001 Term: Human papilloma virus infection Sy
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who the investigator believes can and will comply with the requirements of the protocol or/ and subjects who the investigator believes their parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol. A female between, and including, 9 and 25 years of age at the time of the first vaccination. Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject prior to enrolment in the study. In addition, subjects below the legal age of consent should sign and personally date a written informed assent form. Healthy subjects. Female subjects of non-childbearing potential may be enrolled in the study. Female subjects of childbearing potential may be enrolled in the study, if the subject: 1) has practiced adequate contraception for 30 days prior to vaccination, and 2) has a negative pregnancy test on the day of vaccination, and 3) has agreed to continue adequate contraception during the entire vaccination period and up to two months after the last study vaccine dose. Are the trial subjects under 18? yes Number of subjects for this age range: 1095 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 333 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. A female planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the entire vaccination period and up to two months after the last study vaccine dose. Previous vaccination against HPV or planned administration of another HPV vaccine during the study. Child in care. (A child in care is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian.) Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines. Cancer or autoimmune disease under treatment. Planned administration/administration of a vaccine/product not foreseen by the study protocol within 30 days before each dose of vaccine. Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window. 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. Previous administration of MPL or AS04 adjuvant. Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. Any confirmed or suspected immunosuppressive or immunodeficient condition. Family history of congenital or hereditary immunodeficiency. Major congenital defects or serious chronic illness. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine. Acute disease and/or fever at the time of enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the immunogenicity of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine administered as a 2-dose schedule of 0,6 months in 9-14 year old females is non-inferior to that administered as the standard 3-dose schedule of 0,1,6 months in 15-25 year old females.;Secondary Objective: To demonstrate non-inferiority of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine administered as a 2-dose schedule of 0,12 months in 9-14 year old females as compared to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females. To evaluate if the immunogenicity of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine administered as a 2-dose schedule of 0,12 months in 9-14 year old females is non-inferior to a 2-dose schedule of 0,6 months in 9-14 year old females. To assess the humoral and the cell-mediated immune response to HPV types 16 and 18. To assess the reactogenicity and safety of the vaccine, and the compliance with completion of vaccination in all groups. ;Primary end point(s): Anti-HPV-16/18 seroconversion rates and antibody titres (by ELISA) 1 month after the last dose of study vaccine, in the group (0,6) and the group (0,1,6). ;Timepoint(s) of evaluation of this end point: 1 month after the last dose of study vaccine (Month 7) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Anti-HPV-16/18 seroconversion rates and antibody titres (by ELISA) in all subjects. Anti-HPV-16/18 antibody titres (by Pseudovirion-Based Neutralisation Assay (PBNA)) in a subset of subjects. Anti HPV-16/18 specific T and B cell-mediated immune responses in a sub-cohort of subjects. Occurrence and intensity of solicited local symptoms in all groups. Occurrence, intensity and relationship to vaccination of solicited general symptoms in all groups. Occurrence, intensity and relationship to vaccination of unsolicited symptoms in all groups. Occurrence of potential Immune-Mediated Diseases (pIMDs) in all groups. Occurrence of Medically Significant Conditions (MSCs) in all groups. Occurrence of Serious Adverse Events (SAEs) in all groups. Occurrence of SAEs related to the investigational product, to study participation, to GSK concomitant products or any fatal SAE in all groups. Occurrence of pregnancy and pregnancy outcomes in all groups. The percentage of subjects completing the vaccination schedule in all groups.;Timepoint(s) of evaluation of this end point: ELISA and PBNA: At Day 0 and Months 7, 12, 18, 24 and 36 (for subjects with last vaccine dose at M. 6), or at Day 0 and Months 13, 18, 24 and 36 (for subjects with last vaccine dose at Month 12). T and B cell-mediated immune response: At Day 0, Months 7, 12, 24 and 36 (for subjects with last vaccine dose at M. 6), or at Day 0, Months 13, 18 and 36 (for subjects with last vaccine dose at Month 12). Solicited symptoms: 7-day period following each vaccination. Unsolicited symptoms: 30-day period following each vaccination. pIMDs: From first vaccination to 6 months after the last vaccine dose. MSCs, SAEs, pregnancy: Throughout the study period. Completing vaccination: At Month 6 for subjects with last vaccine dose at M. 6 or at M. 12 for subjects with last vaccine dose at Month 12. | — |
Countries
Canada, Germany, Italy, Taiwan, Thailand
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed