This study evaluated the immunogenicity of a double dose of the seasonal virosomal-adjuvanted influenza vaccine (Inflexal V, Crucell, The Netherlands) in 65 previously unvaccinated children aged less than 3 years: 43 received double doses (two doses of 0.50 mL 4 weeks apart) and 22 standard doses (two doses of 0.25 mL 4 weeks apart). Both treatments evoked a response that satisfied the EMEA criteria for adequate immunogenicity for all three vaccine strains, but the double dose had a significantly greater effect on all of the studied parameters of humoral and cell-mediated immune response (p<0.05). This result was achieved without any increase in the incidence of local and systemic adverse events. This means that doubling the dose of the virosomal-adjuvanted influenza vaccine (i.e. administering the same dose as that usually given to older children) effectively and safely increases the immune response to inactivated influenza vaccine in unprimed children aged less than 3 years.

A randomized clinical trial assessing immunogenicity and safety of a double dose of virosomal-adjuvanted influenza vaccine administered to unprimed children aged 6–35 months / S. Esposito, P.G. Marchisio, F. Ansaldi, S. Bianchini, M. Pacei, E. Baggi, D.L. Trabattoni, G. Icardi, N. Principi. - In: VACCINE. - ISSN 0264-410X. - 28:38(2010 Aug 31), pp. 6137-6144. [10.1016/j.vaccine.2010.07.041]

A randomized clinical trial assessing immunogenicity and safety of a double dose of virosomal-adjuvanted influenza vaccine administered to unprimed children aged 6–35 months

S. Esposito
Primo
;
P.G. Marchisio
Secondo
;
S. Bianchini;M. Pacei;E. Baggi;D.L. Trabattoni;N. Principi
Ultimo
2010-08-31

Abstract

This study evaluated the immunogenicity of a double dose of the seasonal virosomal-adjuvanted influenza vaccine (Inflexal V, Crucell, The Netherlands) in 65 previously unvaccinated children aged less than 3 years: 43 received double doses (two doses of 0.50 mL 4 weeks apart) and 22 standard doses (two doses of 0.25 mL 4 weeks apart). Both treatments evoked a response that satisfied the EMEA criteria for adequate immunogenicity for all three vaccine strains, but the double dose had a significantly greater effect on all of the studied parameters of humoral and cell-mediated immune response (p<0.05). This result was achieved without any increase in the incidence of local and systemic adverse events. This means that doubling the dose of the virosomal-adjuvanted influenza vaccine (i.e. administering the same dose as that usually given to older children) effectively and safely increases the immune response to inactivated influenza vaccine in unprimed children aged less than 3 years.
influenza ; influenza vaccine ; Virosomal ; immunogenicity ; reactogenicity ; children
Settore MED/38 - Pediatria Generale e Specialistica
Settore MED/04 - Patologia Generale
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/152374
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