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 / Esposito, Susanna Maria Roberta; 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), 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

Esposito, Susanna Maria Roberta;
2010

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.
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 / Esposito, Susanna Maria Roberta; 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), pp. 6137-6144. [10.1016/j.vaccine.2010.07.041]
File in questo prodotto:
Non ci sono file associati a questo prodotto.

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11381/2864206
Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus 18
  • ???jsp.display-item.citation.isi??? 17
social impact