Flu-Safe Study from SAFEVIC
Following the 2010 increase in adverse events following immunisation (AEFI) in young children after receiving CSL’s trivalent influenza vaccine [2010 formulation: Fluvax or Fluvax junior], a prospective observational study for the 2011 influenza vaccine season has been established.
In an investigator-led study. SAEFVIC at the Murdoch Childrens Research Institute (MCRI), Melbourne and NCIRS at the Children’s Hospital Westmead, Sydney are collecting adverse event data in a real-time scenario, to help detail the safety profile of the 2011 influenza vaccines. Children 5-18 years of age who are receiving this season’s influenza vaccine (regardless of brand) are invited to take part. The study is funded by CSL.
Participation is for a total of 4 days (including day of vaccination). During this period, participants keep a diary recording an evening temperature (more often if they have a fever), systemic observations such as headache, irritability, malaise & lethargy, and any local reactions such as erythema, induration or swelling. Each evening the participants are contacted by the study team to collect each day’s observations.
Participants are currently recruited from The Royal Children's Hospital Melbourne Immunisation Drop-In centre, The Children’s Hospital at Westmead and three General Practice Clinics in Victoria.
The study is aiming for a total of 600 participants. To date we have had 171 children who have completed the study. Results of the study will be made available toward the end of this year.
For more information regarding this study please contact the study team on (03) 9345 5066 or
saefvic@mcri.edu.au
