Safety and immunogenicity of an inactivated thimerosal-free influenza vaccine in infants and children.
Influenza Other Respir Viruses
; 3(6): 315-25, 2009 Nov.
Article
en En
| MEDLINE
| ID: mdl-19903213
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.
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Vacunas contra la Influenza
/
Gripe Humana
Tipo de estudio:
Clinical_trials
/
Observational_studies
Límite:
Child
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Child, preschool
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Female
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Humans
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Infant
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Male
País/Región como asunto:
Oceania
Idioma:
En
Revista:
Influenza Other Respir Viruses
Asunto de la revista:
VIROLOGIA
Año:
2009
Tipo del documento:
Article
País de afiliación:
Australia