Observational influenza vaccine active surveillance study: A Phase IV Prospective Multi-Centre Cohort Study to Evaluate the Reactogenicity of bioCSL’s influenza virus vaccine (2015/2016 formulation) (CSLCT-SAF-15-07)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/14346
• EU PAS number:
  EUPAS10613
• Study ID:
  14346
• Official title and acronym:
  Observational influenza vaccine active surveillance study: A Phase IV Prospective Multi-Centre Cohort Study to Evaluate the Reactogenicity of bioCSL’s influenza virus vaccine (2015/2016 formulation) (CSLCT-SAF-15-07)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This protocol defines an enhanced active surveillance system that will collect and descriptively summarise participant self-reported reactogenicity data, which will be supplemented by primary care or other health provider data on the details of vaccination, and any Medically attended Adverse Events (MAE) in the seven day period after each bioCSL influenza vaccination in a given year.Descriptive summaries of the reactogenicity and other safety data as defined in the primary and secondary study objectives will allow indirect comparison of data from the study with previous safety data, and data arising from the enhanced safety surveillance system over time, to facilitate safety signal detection for bioCSL’s influenza virus vaccine.Primary objective is to characterise the reactogenicity (local, systemic and allergic reactions) within seven days after each influenza vaccination with bioCSL’s influenza virus vaccine in participants routinely indicated for influenza vaccination in specified age groups.Secondary objective is to assess the frequency and severity of medically attended adverse events occurring within seven days after each influenza vaccination with bioCSL’s influenza virus vaccine, in participants routinely indicated for influenza vaccination in specified age groups.
• Study status:
  Finalised

Research institutions and networks

Institutions

Harbinson House Surgery

Albany House Medical Centre
Knowle House surgery
Honiton Surgey
The Rame Group Practice United Kindgom
Bradford on Avon and Melksham Health Partnership
The Haven Surgery
University of Nottingham Health service
Axbridge & Wedmore Medical Practice
Westbury Group Practice
Pickering Medical Practice
Bradford Road Medical Centre

Networks

NIHR Medicines for Children Research Network

Study timelines

Date when funding contract was signed

Planned: 24/06/2015

Actual: 24/06/2015

Study start date

Planned: 14/09/2015

Actual: 15/09/2015

Data analysis start date

Planned: 05/10/2015

Actual: 05/10/2015

Date of interim report, if expected

Planned: 15/10/2015

Actual: 15/10/2015

Date of final study report

Planned: 01/02/2016

Actual: 03/02/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

bioCSL Pty Ltd

Study protocol

Initial protocol

CSLCT-SAF-15-07_PASS protocol_abstract v1.0

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 2 (specific obligation of marketing authorisation)