Active SMS-based influenza vaccine safety surveillance in Australian children

•Vaccine safety surveillance using parent/carer reported outcomes yields timely data.•Our influenza vaccine safety surveillance system received data from 7402 children.•Vaccine compositions (trivalent/quadrivalent) and brands had similar safety profiles.•Adverse event rates reported were consistent...

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Bibliographic Details
Published in:Vaccine 2017-12, Vol.35 (51), p.7101-7106
Main Authors: Pillsbury, Alexis, Quinn, Helen, Cashman, Patrick, Leeb, Alan, Macartney, Kristine
Format: Article
Language:English
Subjects:
Active surveillance
Adverse event following immunisation
Age
Children
Children & youth
Confidence intervals
Data processing
Fever
Health surveillance
Immunization
Influenza
Influenza vaccine
Information systems
Native peoples
Parents & parenting
Pediatrics
Public health
Receiving
Safety
Short message service
Surveillance
Vaccine safety
Vaccines
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Summary:•Vaccine safety surveillance using parent/carer reported outcomes yields timely data.•Our influenza vaccine safety surveillance system received data from 7402 children.•Vaccine compositions (trivalent/quadrivalent) and brands had similar safety profiles.•Adverse event rates reported were consistent with expected rates.•Concomitant vaccination was associated with higher adverse event reporting rates. Australia’s novel, active surveillance system, AusVaxSafety, monitors the post-market safety of vaccines in near real time. We analysed cumulative surveillance data for children aged 6 months to 4 years who received seasonal influenza vaccine in 2015 and/or 2016 to determine: adverse event following immunisation (AEFI) rates by vaccine brand, age and concomitant vaccine administration. Parent/carer reports of AEFI occurring within 3 days of their child receiving an influenza vaccine in sentinel immunisation clinics were solicited by Short Message Service (SMS) and/or email-based survey. Retrospective data from 2 years were combined to examine specific AEFI rates, particularly fever and medical attendance as a proxy for serious adverse events (SAE), with and without concomitant vaccine administration. As trivalent influenza vaccines (TIV) were funded in Australia’s National Immunisation Program (NIP) in 2015 and quadrivalent (QIV) in 2016, respectively, we compared their safety profiles. 7402 children were included. Data were reported weekly through each vaccination season; no safety signals or excess of adverse events were detected. More children who received a concomitant vaccine had fever (7.5% versus 2.8%; p 
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2017.10.091