Safety and tolerability of a 2009 trivalent inactivated split‐virion influenza vaccine in infants, children and adolescents

Influenza and Other Respiratory Viruses

Stephen B. Lambert⁵  Lai-man R. Chuk¹  Michael D. Nissen¹  Terry M. Nolan²  Jodie McVernon²  Robert Booy⁴  Leon Heron⁴  Peter C. Richmond⁹  Tony Walls⁶  Helen S. Marshall⁷  Graham J. Reynolds⁸  Gunter F. Hartel³  Wilson Hu³ 

[1]Queensland Paediatric Infectious Diseases Laboratory, Sir Albert Sakzewski Virus Research Centre, Queensland Children's Health Services & Clinical Medical Virology Centre, Brisbane, Qld, Australia

[2]Vaccine and Immunisation Research Group, Murdoch Children's Research Institute, Parkville, Vic., Australia

[3]CSL Limited, Parkville, Vic., Australia

[4]National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, Children's Hospital at Westmead, Sydney, NSW, Australia

[5]Queensland Children's Medical Research Institute, The University of Queensland, Brisbane, Qld, Australia

[6]School of Women's and Children's Health, University of New South Wales, Sydney, NSW, Australia

[7]Discipline of Paediatrics, School of Paediatrics and Reproductive Health, University of Adelaide, North Adelaide, SA, Australia

[8]Australian National University Medical School, Canberra Hospital, Woden, ACT, Australia

[9]School of Paediatrics and Child Health, The University of Western Australia, Perth, WA, Australia

关键词: Adverse events;    fever;    influenza vaccine;    paediatrics;    safety;   

DOI  :  10.1111/irv.12107

来源: Wiley

【 摘 要 】

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.

【 授权许可】

Unknown   
© 2013 John Wiley & Sons Ltd