Study Assessing Risk of Autoimmune Diseases in Females (9 - 25 Years) Exposed to Cervarix® in United Kingdom
Condition: Infections, Papillomavirus
MeSH terms: Autoimmune Diseases
Study type: Observational

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.
    

Detailed description: 
      GSK's vaccine Cervarix® protects against Human Papilloma Virus Types-16 and 18-related
      pre-cancerous lesions. GSK is committed by the US Food and Drug Administration (FDA) to
      conduct a safety study to evaluate the incidence of new neurological and eye-related
      autoimmune diseases and other pre-specified autoimmune diseases in subjects receiving
      Cervarix® in the US. Because of the very low Cervarix® uptake in the US, the observational
      GSK study to address this commitment is due to be stopped, as it will take too long to
      recruit the target subjects.

      The unexposed male cohorts will be enrolled in order to assess a possible change over time in
      the incidence rate of new onset of autoimmune disease(s) (NOAD) in the UK Clinical Practice
      Research Datalink General Practitioner OnLine database (CPRD GOLD) independent of Cervarix®
      introduction. The cohorts will be frequency matched for the age (age class of one year) and
      practice region identifier at reference date (age at first dose of Cervarix).

      Additionally, the reference date (time = 0) for the vaccinated (exposed) cohort will be the
      date of the first dose of Cervarix® recorded in CPRD GOLD. The reference date for the
      unexposed (unvaccinated) cohorts will be a date randomly selected among the reference dates
      of the exposed subjects and minus 3 years for the historical cohorts.

      The other observational study model is a self-control case-series (SCCS) analysis for
      confirmed NOAD in the exposed female cohort, using a risk period of one year after the first
      Cervarix® dose, a control period of one year and a six month buffer period between risk and
      control periods.

      Human Papillomavirus Bivalent (Types 16 and 18) vaccine (recombinant) exposed cohort was
      investigated between 1-SEP-2008 and 31-AUG-2010.

      The unexposed concurrent male cohort was investigated between 1-SEP-2008 and 31-AUG-2010.

      Unexposed historical female and male cohorts were investigated between 1-SEP-2005 and
      31-AUG-2007.
    

Intervention name(s): Data collection
Intervention type(s): Other
Intervention description(s): Data collection from an existing electronic healthcare databases - Clinical Practice Research Datalink (CPRD) GOLD.
Observational model: Cohort
Time perspective: Retrospective
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®.
      
Keywords: Observational; Cohort; Autoimmune disease; Cervarix®; Women aged 9 to 25 years; United Kingdom