Infections, Papillomavirus Clinical Trial
Official title:
An Observational Cohort Study to Assess the Risk of Autoimmune Diseases in Adolescent and Young Adult Women Aged 9 to 25 Years Exposed to Cervarix® in the United Kingdom
This is an observational cohort study to assess the risk of autoimmune disease(s) within 12
months of receiving the first dose of Cervarix® in the exposed cohort and over a comparable
period in the unexposed cohorts.
This is an alternative study by GSK using the CPRD database in the UK to fulfil the US FDA
safety commitment. The UK has had sufficient Cervarix® vaccination coverage during the
period mid-September 2008 to 2011 to allow suitable data to be collected.
Status | Completed |
Enrollment | 1053 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 9 Years to 25 Years |
Eligibility |
Inclusion Criteria: Note: Other vaccines are allowed in this study regardless of the time of administration and the time interval between subsequent doses. Inclusion criteria for the exposed female cohort: - Female aged from 9 to 25 years at the reference date (01 September 2008 through 31 August 2010). - Recorded in the CPRD GOLD for at least 12 months before the reference date. - The first dose of Cervarix received between 01 September 2008 through 31 August 2010, Full date (day/month/year) of Cervarix vaccination(s) available. - Subject defined as acceptable in CPRD GOLD. Inclusion criteria for the unexposed historical female cohort: - Female aged 9 to 25 years at the reference date (01 September 2005 through 31 August 2007). - Recorded in the CPRD GOLD for at least 12 months before the reference date. - Subject defined as acceptable in CPRD GOLD. Inclusion criteria for the unexposed concurrent male cohort: - Male aged 9 to 25 years at the reference date (01 September 2008 through 31 August 2010). - Recorded in the CPRD GOLD for at least 12 months before the reference date. - Subject defined as acceptable in CPRD GOLD. Inclusion criteria for the unexposed historical male cohort: - Male aged 9 to 25 years at the reference date (01 September 2005 through 31 August 2007). - Recorded in the CPRD GOLD for at least 12 months before the reference date. - Subject defined as acceptable in CPRD GOLD. Exclusion Criteria: Exclusion criteria for all cohorts: - Subjects with a diagnostic code of any auto-immune disease during the year prior to the reference date. - Subjects who received at least one dose of unspecified HPV vaccine or Gardasil at any time before the reference date. - Subjects who have been included in the other cohort. Exclusion criteria for the non-exposed cohorts: • Subjects who received any dose of Cervarix at any time before the reference date. |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of new onset of confirmed autoimmune disease for neuroinflammatory/ophthalmic autoimmune diseases | Neuroinflammatory/ophthalmic autoimmune diseases: -Multiple Sclerosis; -Transverse myelitis; -Optic neuritis; -Guillain-Barré syndrome, including Miller Fisher syndrome and other variants; -Other demyelinating diseases: -Acute disseminated encephalomyelitis, including site specific variants: e.g. non-infectious encephalitis, encephalomyelitis, myelitis, myeloradiculomyelitis; -AI peripheral neuropathies and plexopathies (including chronic inflammatory demyelinating polyneuropathy, multifocal motor neuropathy and polyneuropathies associated with monoclonalgammopathy); -Auto-immune uveitis; | During the period of 1 year following administration of the first dose of Cervarix® (risk period) among an exposed cohort and during an equivalent time period in the unexposed cohorts | No |
Primary | Occurrence of new onset of confirmed autoimmune disease for other autoimmune diseases | Other autoimmune diseases: -Systemic lupus erythematous; -Autoimmune (AI) disease with rheumatologic conditions: -Rheumatoid arthritis (RA);-Juvenile rheumatoid arthritis (JRA); -Still's disease; -Psoriatic arthritis; -Ankylosing Spondylitis; -AI haematological conditions: -Idiopathic thrombocytopenic purpura (ITP); -AI haemolytic anaemia; -AI endocrine conditions: -Type 1 diabetes mellitus; -AI thyroiditis including Hashimoto's disease, Graves' /Basedows' disease; -Inflammatory bowel / hepatic diseases: -Crohn's diseases; -Ulcerative colitis; -Autoimmune hepatitis; | During the period of 1 year following administration of the first dose of Cervarix® (risk period) among an exposed cohort and during an equivalent time period in the unexposed cohorts | No |
Secondary | Occurrence of Guillain Barré syndrome (including Miller Fisher syndrome and other variants), and autoimmune haemolytic anaemia | Within 2 months following the administration of the first dose of Cervarix® | No | |
Secondary | Occurrence of idiopathic thrombocytopenic purpura (ITP) | Within six months following the administration of the first dose of Cervarix® | No | |
Secondary | Occurrence of new onset of individual confirmed autoimmune disease | Occurrence of multiple sclerosis, transverse myelitis, optic neuritis, other demyelinating diseases, auto-immune uveitis, systemic lupus erythematous (SLE), rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), Still's disease, psoriatic arthritis, ankylosing spondylitis, type 1 diabetes mellitus, auto-immune thyroiditis (including Hashimoto's disease, Graves'/Basedows' disease), and inflammatory bowel / hepatic disease (Crohn's disease, ulcerative colitis and autoimmune hepatitis) | Within 1 year following the administration of the first dose of Cervarix® | No |
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