cervical cancer: the study is conducted in healthy female adolescents
Conditions
Interventions
Product Name: Prophylactic bivalent HPV/AS04 Vaccine candidate
Product Code: HPV
Pharmaceutical Form: Injection*
Other descriptive name: Recombinant L1 proteins from Human Papilloma Virus type-16 & -1
Sponsors
GlaxoSmithKline AS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female subjects 10 – 14 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.) Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: 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. Pregnant or breastfeeding. Planning to become pregnant or likely to become pregnant. 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 infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare between the HPV vaccine group and the control group (Havrix™ recipients) the occurrence of serious adverse events (SAEs) throughout the study period (up to month 7). ;Secondary Objective: Evaluate solicited local and general symptoms during the 7-days after vaccination & unsolicited symptoms during the 30-days after vaccination. Evaluate between the HPV vaccine and control groups occurrence of new onset chronic diseases and other medically significant conditions. Evaluate in pre-specified sites the effect of vaccination on biochemical & haematological parameters at months 0, 2 & 7. Evaluate in HPV vaccine recipients from pre-specified sites: antibody responses against HPV-16 & -18 and against MPL at months 0,2,7. Compare, one month after the third dose the immune responses to the HPV vaccine in healthy females aged 10–14 years in this study with responses from adults of the efficacy study 580299/001 (HPV-001). Compare between the HPV vaccine group and the control group the occurrence of SAEs, new onset chronic diseases and other medically significant conditions through the month 12 follow-up telephone call (annex analysis). ;Primary end point(s): Occurrence of SAEs throughout the study period (up to month 7). | — |
Countries
Norway, Spain
Outcome results
None listed