bioCSL Influenza Vaccine PASS
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. (CSLCT-SAF-14-05)
IRAS ID
162355
Contact name
David Bibby
Contact email
Sponsor organisation
bioCSL PTY LTD
Clinicaltrials.gov Identifier
PL 22236/0001 (MHRA licence number), Product reference
Research summary
This observational research study will be implemented through the primary care research network 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 sub-groups 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 selected 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 immune-compromised 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
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
14/SW/1080
Date of REC Opinion
4 Sep 2014
REC opinion
Further Information Favourable Opinion