BACKGROUND: Intradermal vaccination provides direct and potentially more efficient access to the immune system via specialised dendritic cells and draining lymphatic vessels. We investigated the immunogenicity and safety during 3 successive years of different dosages of a trivalent, inactivated, split-virion vaccine against seasonal influenza given intradermally using a microinjection system compared with an intramuscular control vaccine. METHODS: In a randomised, partially blinded, controlled study, healthy volunteers (1150 aged 18 to 57 years at enrollment) received three annual vaccinations of intradermal or intramuscular vaccine. In Year 1, subjects were randomised to one of three groups: 3 microg or 6 microg haemagglutinin/strain/dose of inactivated influenza vaccine intradermally, or a licensed inactivated influenza vaccine intramuscularly containing 15 microg/strain/dose. In Year 2 subjects were randomised again to one of two groups: 9 microg/strain/dose intradermally or 15 microg intramuscularly. In Year 3 subjects were randomised a third time to one of two groups: 9 microg intradermally or 15 microg intramuscularly. Randomisation lists in Year 1 were stratified for site. Randomisation lists in Years 2 and 3 were stratified for site and by vaccine received in previous years to ensure the inclusion of a comparable number of subjects in a vaccine group at each centre each year. Immunogenicity was assessed 21 days after each vaccination. Safety was assessed throughout the study. RESULTS: In Years 2 and 3, 9 microg intradermal was comparably immunogenic to 15 microg intramuscular for all strains, and both vaccines met European requirements for annual licensing of influenza vaccines. The 3 microg and 6 microg intradermal formulations were less immunogenic than intramuscular 15 microg. Safety of the intradermal and intramuscular vaccinations was comparable in each year of the study. Injection site erythema and swelling was more common with the intradermal route. CONCLUSION: An influenza vaccine with 9 microg of haemagglutinin/strain given using an intradermal microinjection system showed comparable immunogenic and safety profiles to a licensed intramuscular vaccine, and presents a promising alternative to intramuscular vaccination for influenza for adults younger than 60 years. TRIAL REGISTRATION: (Clinicaltrials.gov) NCT00703651.

• MeSH
• chřipka lidská imunologie   prevence a kontrola   MeSH
• dospělí MeSH
• inaktivované vakcíny aplikace a dávkování   imunologie   MeSH
• injekce intradermální MeSH
• lidé středního věku MeSH
• lidé MeSH
• mikroinjekce metody   MeSH
• mladý dospělý MeSH
• vakcíny proti chřipce aplikace a dávkování   imunologie   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• inaktivované vakcíny MeSH
• vakcíny proti chřipce MeSH

Influenza related mortality rates have been established in many countries; nevertheless, studies focusing on the Central European population have been rare to date. We assess mortality attributable to influenza by comparing all cause mortality and mortality due to diseases of the circulatory system during influenza epidemic and non-epidemic periods, as defined by acute respiratory infection surveillance data. Data on total mortality, mortality due to diseases of the circulatory system and surveillance data for influenza and other respiratory infections were used in a general linear model with a logarithmic link for dependence of left censored mortality data over time, and week as a categorical factor. Results of the analysis show statistically significant (p <0.001) differences in excess mortality rates between influenza epidemic and non-epidemic periods in the Czech Republic between 1982 and 2000. We estimate that 2.17% of all cause mortality, and 2.57% of mortality due to diseases of the circulatory system throughout the study period was attributable to influenza, with an estimated annual average of 2661 and 1752 deaths respectively. The highest numbers of deaths were reported during seasons when influenza A/H3N2 was the predominant circulating strain. Improving vaccination coverage against influenza is considered to be the primary strategy for prevention of influenza associated mortality.

• MeSH
• chřipka lidská epidemiologie   mortalita   MeSH
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladiství MeSH
• senioři MeSH
• surveillance populace MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladiství MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Česká republika epidemiologie   MeSH