The results showed that 2 doses of AS03-adjuvanted H5N1 influenza vaccine at antigen-sparing doses of 1.9 microg or 3.75 microg HA elicited broad and persistent immune responses with acceptable reactogenicity, and without safety concerns, in children aged 3 to 9 years.

This observational, prospective study was undertaken to estimate the burden of rotavirus (RV) gastroenteritis (GE) leading to general practitioner (GP)/family paediatrician (FP) visits among children aged <5 years in Czech Republic, Germany, Italy, Poland, Spain and the UK. Children aged <5 years presenting with acute GE provided stool samples for rapid RV testing. RV+ samples were confirmed and typed by RT-PCR. Demographic and clinical data were collected for all RVGE episodes. Transmission patterns among other household children aged <5 years were also assessed. From November 2005 to May 2007, excluding data from the UK, 497/3,813 (13.0%) children aged <5 years presenting with acute GE to GP/FP and tested were RV+ by PCR. Most RVGE cases (69.1%) occurred in children aged <2 years, occurred between December and May (93.1%) and were moderate or severe by Vesikari score (92.9%). RV strain distribution varied between countries: G9P[8] was the most common type in Poland (54/76) and Spain (172/196), G1P[8] was predominant in the Czech Republic (56/64) and Italy (46/107), and G4P[8] and G1P[8] both prevailed in Germany (17/54 and 13/54, respectively). A total of 24/122 (19.7%) children aged <5 years resident in the same household as a PCR+ study participant also developed RVGE. Conclusion. This multinational epidemiological study in Europe shows that RV is easily transmitted among household children, with RVGE burden highest among children aged <2 years accessing primary healthcare for acute GE.

BackgroundAn AS03-adjuvanted H5N1 influenza vaccine elicited broad and persistent immune responses with an acceptable safety profile up to 6 months following the first vaccination in children aged 3–9 years.MethodsIn this follow-up of the Phase II study, we report immunogenicity persistence and safety at 24 months post-vaccination in children aged 3–9 years. The randomized, open-label study assessed two doses of H5N1 A/Vietnam/1194/2004 influenza vaccine (1·9 μg or 3·75 μg hemagglutinin antigen) formulated with AS03A or AS03B (11·89 mg or 5·93 mg tocopherol, respectively). Control groups received seasonal trivalent influenza vaccine. Safety was assessed prospectively and included potential immune-mediated diseases (pIMDs). Immunogenicity was assessed by hemagglutination-inhibition assay 12 and 24 months after vaccination; cross-reactivity and cell-mediated responses were also assessed. (NCT00502593).ResultsThe safety population included 405 children. Over 24 months, five events fulfilled the criteria for pIMDs, of which four occurred in H5N1 vaccine recipients, including uveitis (n = 1) and autoimmune hepatitis (n = 1), which were considered to be vaccine-related. Overall, safety profiles of the vaccines were clinically acceptable. Humoral immune responses at 12 and 24 months were reduced versus those observed after the second dose of vaccine, although still within the range of those observed after the first dose. Persistence of cell-mediated immunity was strong, and CD4+ T cells with a TH1 profile were observed.ConclusionsTwo doses of an AS03-adjuvanted H5N1 influenza vaccine in children showed low but persistent humoral immune responses and a strong persistence of cell-mediated immunity, with clinically acceptable safety profiles up to 24 months following first vaccination.

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