Post-licensure observational safety study of specific outcomes after Optaflu vaccination among adults in The Health Improvement Network (THIN) database of routine UK primary care records (V58_30OB (FLUPASS1))

Study identification

• EU PAS number:
  EUPAS4101
• Study ID:
  23738
• Official title and acronym:
  Post-licensure observational safety study of specific outcomes after Optaflu vaccination among adults in The Health Improvement Network (THIN) database of routine UK primary care records (V58_30OB (FLUPASS1))
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  A post authorization safety study of cTIV influenza vaccination in adults in the UK. The objective of the study is hypothesis generating with regard to pre-specified outcomes considered to be biologically plausible adverse events to vaccinations.The outcomes are anaphylactic reactions and angioedema, Bell’s palsy, convulsions, demyelination including Guillain-Barre syndrome (GBS), neuritis, non-infectious encephalitis and vasculitis. Information on exposure, outcomes, demographic details and prevalent medical conditions will be identified from the THIN UK database of primary care records and through follow-up with the primary care practices which contribute to this resource. People exposed to cTIV will be identified and their records searched to identify possible cases of the study outcomes from three months before to six months after the vaccination date. Records for these patients will be reviewed and judged as a case or not by an Adjudication Committee using pre-defined case definitions. The distribution of cases of each study outcome in relation to the vaccination date will be reviewed. When an outcome occurs in a predefined risk window, the ratio of observed (in the risk window) to expected (outside this window) cases will be estimated. The six month incidence rates will also be calculated in total and for those chronic disease groups who are recommended to have influenza vaccinations.
• Study status:
  Finalised

Research institutions and networks

Institutions

Gillian Hall

United Kingdom

Study timelines

Date when funding contract was signed

Planned:25/03/2013

Actual:25/03/2013

Study start date

Planned:16/07/2013

Actual:20/08/2013

Data analysis start date

Planned:17/03/2014

Actual:26/03/2014

Date of interim report, if expected

Planned:28/04/2014

Actual:22/04/2014

Date of final study report

Planned:30/05/2017

Actual:29/06/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis, now Seqirus

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)