Authors:
Lambert SB, Chuk LMR, Nissen MD, Nolan TM, McVernon J, Booy R, Heron L, Richmond PC, et al.
Authors notes:
Influenza and other Respiratory Viruses. 2013:online
Keywords:
Adverse events, Fever, Influenza vaccine, Paediatrics, Safety
Abstract:
To evaluate the safety of CSL's split-virion inactivated trivalent 2009 Southern Hemisphere formulation influenza vaccine (TIV) in children.
At least one solicited adverse event (AE) was reported by 80%/78%/78% of children in Cohorts A, B and C, respectively.
Systemic AEs were more common among Cohort A (72% of participants), and local AEs were more common among Cohort C (71% of participants).
Fever was more common in younger cohorts, in influenza vaccine-naïve children (29% of Cohort A receiving their first dose), and following first compared with second doses.
Severe fever following a first dose prevented 20 participants receiving their second scheduled vaccine dose.
A 7-month-old participant had a single uncomplicated febrile convulsion on the day of vaccination.
Nearly 80% of subjects reported at least one solicited AE following immunization.
Fever prevalence was highest in vaccine-naïve Cohort A participants, similar to other paediatric studies using CSL vaccine.
Further research to understand fever-related AEs in children following CSL's TIV is recommended.