Study Assessing Risk of Autoimmune Diseases in Females (9 - 25 Years) Exposed to Cervarix® in United Kingdom

NCT01953822 | Completed

• 1 other identifier: 116239
• Study Type: observational
• Target: 1,053
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Infections, Papillomavirus

Keywords

Observational; Cohort; Autoimmune disease; Cervarix®; Women aged 9 to 25 years; United Kingdom

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (3)

• 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®

• Occurrence of idiopathic thrombocytopenic purpura (ITP)

  Within six months following the administration of the first dose of Cervarix®

• Occurrence of new onset of individual confirmed autoimmune disease

  Within 1 year following the administration of the first dose of Cervarix®

Study Arms (4)

Cervarix vaccinated (exposed) female cohort

Female subjects vaccinated with at least one dose of Cervarix® between the ages of 9 to 25 years.

Other: Data collection

Unexposed historical female cohort

Unexposed female subjects identified from historical data, will be frequency matched for age and practice region identifier to the subjects included in the vaccinated (exposed) cohort.

Other: Data collection

Unexposed concurrent male cohort

Male population is composed of 9- to 25-year-old male subjects not vaccinated with Cervarix®.

Other: Data collection

Unexposed historical male cohort

Male population is composed of 9- to 25-year-old male subjects not vaccinated with Cervarix®. Comparison of the unexposed concurrent male cohort with the unexposed historical male cohort will be used as an internal control for changes over time in Clinical Practice Research Datalink (CPRD) GOLD in reporting New Onset of Autoimmune Diseases (NOAD). The male subjects will be frequency matched for age and practice region identifier to the subjects included in the vaccinated (exposed) cohort.

Other: Data collection

Interventions

Data collection OTHER

Data collection from an existing electronic healthcare databases - Clinical Practice Research Datalink (CPRD) GOLD.

Cervarix vaccinated (exposed) female cohort; Unexposed concurrent male cohort; Unexposed historical female cohort; Unexposed historical male cohort

Eligibility Criteria

• Age: 9 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Female population is composed of female subjects vaccinated with Cervarix® between the ages of 9 to 25 years and unexposed female subjects identified from historical data. Male population is composed of 9- to 25-year-old male subjects not vaccinated with Cervarix®.

You may qualify if:

• Note: Other vaccines are allowed in this study regardless of the time of administration and the time interval between subsequent doses.
• 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.
• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• Subjects who received any dose of Cervarix at any time before the reference date.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Papillomavirus Infections; Autoimmune Diseases

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 1, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 26, 2016

Record last verified: 2016-12