bioCSL Influenza Vaccine PASS 2015
Research type
Research Study
Full title
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-15-17)
IRAS ID
187081
Contact name
James Larcombe
Contact email
Sponsor organisation
bioCSL PTY LTD
Clinicaltrials.gov Identifier
PL22236/0001 (MHRA Licence Number), Product reference
Duration of Study in the UK
0 years, 4 months, 31 days
Research summary
This observational research study will be implemented through the primary care section of division 5 of the National Institute for Health Research in the United Kingdom.
People who have, or are just about to be, routinely vaccinated with bioCSL’s influenza virus vaccine will be invited to enrol in the study. Study participants will be asked to report solicited adverse events occurring within seven days after each vaccination and medically attended adverse events that have symptom onset within seven days after each vaccination, via an internet based survey. The rates of adverse events after vaccination in the overall cohort, and in pre-specified age subgroups of the cohort will be described.
This proposed multicentre, observational study, will include approximately 400 patients being treated with bioCSL’s influenza virus vaccine at approximately 10 sites throughout United Kingdom.
This observational post-marketing study is designed to capture the population receiving bioCSL’s influenza virus vaccine regardless of age or health status in order to provide a picture of the safety profile in routine practice. Pregnant and immunocompromised participants, and children aged less than 5 are not excluded from this study if they have been administered bioCSL’s influenza virus vaccine as part of routine care, or inadvertently prior to enrolment in the study.REC name
North West - Preston Research Ethics Committee
REC reference
15/NW/0632
Date of REC Opinion
23 Jul 2015
REC opinion
Favourable Opinion