title: Safety and tolerability of a 2009 trivalent inactivated split-virion influenza vaccine in infants, children and adolescents.
abstract: OBJECTIVE
  To evaluate the safety of CSL's split-virion inactivated trivalent 2009 Southern Hemisphere formulation influenza vaccine (TIV) in children.
  
  
  METHODS
  We enrolled 1992 healthy children into three groups: Cohorts A, ≥ 6 months to <3 years; B, ≥ 3 years to <9 years; and C, ≥ 9 years to <18 years. Children received one or two doses of 0.25 ml (22.5 μg haemagglutinin) or 0.5 ml (45 μg) TIV, depending on age and prior vaccination history. We collected post-vaccination solicited adverse event (AE) data (days 0-6), including fever (temperature: ≥ 37.5°C axilla, ≥ 38.0°C oral), unsolicited AEs (days 0-29) and serious AEs (SAEs) and new-onset chronic illnesses (NOCIs; to day 180 after last vaccination).
  
  
  RESULTS
  At least one solicited 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Queensland Paediatric Infectious Diseases Laboratory, Sir Albert Sakzewski Virus Research Centre, Queensland Children's Health Services & Clinical Medical Virology Centre, Brisbane, Qld, Australia. sblambert@uq.edu.au
authors.forename: Stephen B
authors.initials: SB
authors.lastname: Lambert
authors.forename: Lai-man R
authors.initials: LM
authors.lastname: Chuk
authors.forename: Michael D
authors.initials: MD
authors.lastname: Nissen
authors.forename: Terry M
authors.initials: TM
authors.lastname: Nolan
authors.forename: Jodie
authors.initials: J
authors.lastname: McVernon
authors.forename: Robert
authors.initials: R
authors.lastname: Booy
authors.forename: Leon
authors.initials: L
authors.lastname: Heron
authors.forename: Peter C
authors.initials: PC
authors.lastname: Richmond
authors.forename: Tony
authors.initials: T
authors.lastname: Walls
authors.forename: Helen S
authors.initials: HS
authors.lastname: Marshall
authors.forename: Graham J
authors.initials: GJ
authors.lastname: Reynolds
authors.forename: Gunter F
authors.initials: GF
authors.lastname: Hartel
authors.forename: Wilson
authors.initials: W
authors.lastname: Hu
authors.forename: Michael H
authors.initials: MH
authors.lastname: Lai
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D004361:Drug Tolerance; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology*; D005260:Female; D005334:Fever / Q000209:etiology; D006801:Humans; D007223:Infant; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D011446:Prospective Studies; D014611:Vaccination / Q000009:adverse effects*; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D007252:Influenza Vaccines; D015164:Vaccines, Inactivated
keywords: Adverse events; fever; influenza vaccine; paediatrics; safety
references.citation: Curr Opin Infect Dis. 2007 Jun;20(3):259-63
references.pmid: 17471035
references.citation: J Clin Virol. 2009 Jul;45(3):203-4
references.pmid: 19515611
references.citation: BMJ Open. 2011 May 30;1(1):e000016
references.pmid: 22021725
references.citation: Med J Aust. 2010 Jan 18;192(2):94-7
references.pmid: 20078411
references.citation: JAMA. 2000 Oct 4;284(13):1677-82
references.pmid: 11015798
references.citation: J Infect Dis. 1970 Jul-Aug;122(1):16-25
references.pmid: 5433709
references.citation: Vaccine. 2012 Dec 7;30(51):7400-6
references.pmid: 23063831
references.citation: J Pediatr. 2008 Dec;153(6):764-70
references.pmid: 18621393
references.citation: Vaccine. 2005 Feb 18;23(13):1540-8
references.pmid: 15694506
references.citation: N Engl J Med. 2001 Mar 22;344(12):889-96
references.pmid: 11259722
references.citation: CMAJ. 2011 Sep 20;183(13):E1025-32
references.pmid: 21930745
references.citation: Epidemiol Infect. 2006 Feb;134(1):71-8
references.pmid: 16316494
references.citation: Commun Dis Intell Q Rep. 2004;28(4):510-6
references.pmid: 15745401
references.citation: Cochrane Database Syst Rev. 2008 Apr 16;(2):CD004879
references.pmid: 18425905
references.citation: JAMA. 2003 Sep 24;290(12):1608-16
references.pmid: 14506120
references.citation: Influenza Other Respir Viruses. 2013 Sep;7(5):676-85
references.pmid: 23551933
references.citation: JAMA. 2010 Jan 6;303(1):37-46
references.pmid: 20026597
references.citation: Pediatr Infect Dis J. 2011 Feb;30(2):107-11
references.pmid: 21079528
references.citation: Vaccine. 2011 Jul 18;29(32):5107-13
references.pmid: 21640152
references.citation: MMWR Recomm Rep. 2010 Aug 6;59(RR-8):1-62
references.pmid: 20689501
references.citation: Respir Res. 2008 Jan 24;9:11
references.pmid: 18215329
references.citation: PLoS Med. 2008 Oct 28;5(10):e211
references.pmid: 18959473
references.citation: Med J Aust. 2011 Sep 19;195(6):318-20
references.pmid: 21929484
references.citation: Influenza Other Respir Viruses. 2009 Nov;3(6):315-25
references.pmid: 19903213
references.citation: Pediatrics. 2008 Jul;122(1):e260-5
references.pmid: 18595972