No medical condition will be investigated in this study. The study will follow vaccinated females and collect safety data focussing on autoimmune diseases, pregnancy outcomes and SAEs considered to be related to the vaccine.
Conditions
Interventions
Trade Name: Cervarix ™
Product Name: Cervarix ™
Product Code: HPV-16/18 L1 VLP AS04 vaccine
Pharmaceutical Form: Suspension for injection
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female subjects who the GP or other healthcare professional believes that they can and will comply with the requirements of the protocol (e.g. willing to receive full vaccination course, available for a 24 month follow-up period) should be enrolled in the study. A female between, and including, 18-25 years of age at the time of the first vaccination (i.e. ineligible on the subject’s 26th birthday). Female subjects who are registered with a GP practice in Scotland. Written informed consent obtained from the female subject. Willing to give permission for their paper record, electronic medical records and prescribing data to be accessed and abstracted by study investigators. Willing to be contacted and interviewed by study investigators, should the need arise for assessment of all events of interest to the study. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previous vaccination against HPV or HAV. Hypersensitivity to the active substances or to any of the excipients of the vaccines. Suffering from an acute severe febrile illness. However, the presence of a minor infection, such as a cold, is not a contraindication for immunization. Pregnant or lactating female (self-reported). Subjects of childbearing potential must not be pregnant. Absence of pregnancy should be verified (e.g. urine pregnancy test) as per the investigator's clinical judgement. Female planning to become pregnant or planning to discontinue contraceptive precautions from first dose of vaccine up to 2 months after the last dose of vaccine. Females with confirmed diagnosis of AIDs. Females with a suspected diagnosis of an AID can be enrolled in the study if before the end of the recruitment period it is firmly established that the disease in question is not an AID. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether there is an increased incidence of neuroinflammatory AIDs or other autoimmune diseases, with onset during the theoretical risk period of 12 months (the period beginning with administration of the first dose and ending 6 months after the last dose of vaccine) in the group vaccinated with Cervarix® compared to the group vaccinated with Havrix®.; Secondary Objective: To evaluate whether there is an increased incidence of systemic, organ-specific T-cell mediated, or organ specific-antibody mediated AIDs with onset during the theoretical risk period of 12 months (the period beginning with administration of the first dose and ending 6 months after the last dose of vaccine) in the group vaccinated with Cervarix® compared to the group vaccinated with Havrix®. To assess the impact of vaccination on pregnancy measured as incidence of adverse pregnancy outcomes. To assess the safety of the vaccines administered with regards to SAEs considered by the investigator to be possibly related to vaccination in both groups throughout the study period. ; Primary end point(s): Occurrence of validated AIDs during the theoretical risk period within the following two composite endpoints [1] Neuroinflammatory autoimmune diseases: multiple sclerosis, transverse myelitis, optic neuritis, Guillain-Barré syndrome, demyelinating disease. [2] Other autoimmune diseases: myasthenia gravis, autoimmune uveitis, rheumatoid arthritis, juvenile rheumatoid arthritis, reactive arthritis, ankylosing spondylitis, undifferentiated spondylarthropathy, psoriatic arthritis, cutaneous lupus, systemic lupus erythematosus, Sjögren’s syndrome, scleroderma, dermatomyositis, insulin-dependent diabetes mellitus, Grave/Basedow disease, autoimmune thyroiditis, Hashimoto thyroiditis, Addison’s disease, Crohn’s disease, ulcerative colitis, inflammatory bowel disease, Coeliac di | — |
Countries
United Kingdom
Outcome results
None listed