Safety, tolerability and immunogenicity of a mammalian cell-culture-derived influenza vaccine: A sequential Phase I and Phase II clinical trial
作者： N. Groth , E. Montomoli , C. Gentile , I. Manini , R. Bugarini
DOI: 10.1016/J.VACCINE.2008.11.003
关键词: Immunology 、 Vaccination 、 Clinical trial 、 Tolerability 、 Influenza vaccine 、 Reactogenicity 、 Immunogenicity 、 Immunization 、 Randomized controlled trial 、 Medicine 、 Public Health, Environmental and Occupational Health 、 General Immunology and Microbiology 、 Molecular medicine 、 General Veterinary 、 Infectious Diseases
摘要: Abstract This sequential, observer-blind, randomised, single-centre, combined Phase I and II clinical trial compared the tolerability immunogenicity of a single intramuscular dose novel cell-culture-derived influenza vaccine (CCIV), produced in Madin–Darby canine kidney cells, with conventional egg-based vaccine. The both vaccines was assessed by SRH assay, well-recognized test EMEA, compliance requirements EU Committee for Medicinal Products Human Use (CHMP). part comprised 40 healthy adults (18–40 years age); subsequent involved 200 adult (n = 80, 18–60 age) elderly (n = 120, ≥61 subjects. Both showed similar reactogenicity any solicited local or systemic reactions were mostly mild moderate. Regarding immunogenicity, CCIV control met all criteria each strain age groups. In conclusion, mammalian cell-culture is as well tolerated immunogenic non-elderly adults.
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