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Influenza Other Respir Viruses. 2009 Nov;3(6):315-25. doi: 10.1111/j.1750-2659.2009.00108.x.

Safety and immunogenicity of an inactivated thimerosal-free influenza vaccine in infants and children.

Author information

1
Vaccine and Immunisation Research Group at the Murdoch Children's Research Institute and the Melbourne School of Population Health, University of Melbourne, Victoria 3010, Australia. t.nolan@unimelb.edu.au

Abstract

OBJECTIVE:

Few prospective studies of inactivated split virion influenza vaccine have been conducted in infants and children. Our objective was to evaluate the safety, reactogenicity and immunogenicity of a thimerosal-free inactivated influenza vaccine (Fluvax; CSL Limited, Parkville, Australia) in children aged 6 months to <9 years.

METHODS:

A prospective, open-label, phase III clinical trial was conducted in 298 healthy children previously unvaccinated with influenza, commencing in the Southern Hemisphere 2005 autumn. Participants were divided into two groups (Group A: > or =6 months to <3 years; Group B: > or =3 years to <9 years), and received two doses of the 2005 vaccine, and one dose of the 2006 vaccine one year later (Group A: 0.25 ml per dose; Group B: 0.5 ml per dose). Vaccine safety and reactogenicity was evaluated for 30 days after each dose. Immunogenicity was assessed using hemagglutination inhibition and single radial hemolysis assays.

RESULTS:

There were no withdrawals due to adverse events (AEs). The majority of solicited local and systemic AEs were of mild severity. A maximum intensity of severe was reported for injection site pain and fever by only 3.0% and 3.4% of participants, respectively. The vaccine was immunogenic for all antigens, with > or =95% of both younger and older children achieving seroprotection after dose 2.

CONCLUSIONS:

This thimerosal-free inactivated influenza vaccine had a favorable safety profile and was immunogenic in children aged > or =6 months and <9 years. Primary and booster vaccination produced consistently immunogenic responses including in children under 3 years of age receiving 0.25 ml doses of vaccine.

PMID:
19903213
PMCID:
PMC4941394
DOI:
10.1111/j.1750-2659.2009.00108.x
[Indexed for MEDLINE]
Free PMC Article

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