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.
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.
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Observational Model: Cohort, Time Perspective: Retrospective
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