116239 - 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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/31665
• EU PAS number:
  EUPAS4584
• Study ID:
  31665
• Official title and acronym:
  116239 - 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
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  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 (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 UK has had sufficient Cervarix® vaccination coverage during the period mid-September 2008 to 2011 to allow suitable data to be collected.Four cohorts will be defined based on exposure to Cervarix and sex as recorded in the CPRD GOLD data source:1. Cervarix vaccinated (exposed) female cohort2. Unexposed historical female cohort3. Unexposed concurrent male cohort4. Unexposed historical male cohortNOAD represent a heterogeneous group of diseases with different clinical conditions and disease progression. Some NOAD present with a chronic disease pattern of relapse over time e.g. multiple sclerosis or systemic lupus erythematous, or an acute disease pattern (e.g. Guillain Barré Syndrome).In addition to the comparison of the exposed vs. non exposed cohort (cohort design), the confirmed NOAD in the exposed cohort will also be analysed using a self-control case series (SCCS) analysis.In the cohort design, specified NOAD will be collected over a period of one year following the administration of at least one dose of Cervarix in an exposed cohort and over a comparable period in the unexposed cohorts.The unexposed male cohorts will be enrolled in order to assess a possible change over time in the incidence rate of NOAD in CPRD GOLD independent of Cervarix introduction.
• Study status:
  Finalised

Research institutions and networks

Institutions

Clinical Practice Research Datalink (CPRD)

United Kingdom

Study timelines

Date when funding contract was signed

Actual: 19/07/2013

Study start date

Actual: 28/10/2013

Data analysis start date

Actual: 26/08/2014

Date of final study report

Actual: 23/03/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

EPI-HPV-040 VS UK (116239) Protocol (FDA - EMA PASS) (09-Jul-2013)_PASS Registry

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)