A TritonX-100-split Virion Influenza Vaccine is Safe and Fulfills the Committee for Proprietary Medicinal Products (CPMP) Recommendations for the European Community for Immunogenicity,in Children,Adults and the Elderly |
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| Institution: | 1. Laboratoire de Virologie, Centre National de Référence de la Grippe (France Sud), Faculté de Médecine Lyon Grange Blanche, Domaine Rockefeller, F-69373, Lyon, cedex 08, France;2. Medical Affairs, Aventis Pasteur SA, 2 avenue Pont Pasteur, F-69367, Lyon, cedex 07, France;1. Department of Chemical Engineering, Faculty of Engineering, Chulalongkorn University, Bangkok 10330, Thailand;2. Department of Chemical Engineering, Faculty of Engineering and Industrial Technology, Silpakorn University, Nakhon Pathom 73000, Thailand;1. Division of Allergy/Immunology and Rheumatology, University of Rochester, 601 Elmwood Avenue, Rochester, NY 14642, United States;2. Department of Biomedical Genetics, University of Rochester, 601 Elmwood Avenue, Rochester, NY 14642, United States;3. Department of Biology, University of Rochester, 601 Elmwood Avenue, Rochester, NY 14642, United States;4. Department of Pediatrics, University of Rochester, 601 Elmwood Avenue, Rochester, NY 14642, United States;5. Department of Dermatology, University of Rochester, 601 Elmwood Avenue, Rochester, NY 14642, United States;6. Department of Pathology, University of Rochester, 601 Elmwood Avenue, Rochester, NY 14642, United States;7. Department of Medicine, University of Rochester, 601 Elmwood Avenue, Rochester, NY 14642, United States;8. Department Biomedical Engineering, University of Houston, Houston, TX 77204, United States;1. Children’s Cancer Research Institute, Zimmermannplatz 10, 1090 Vienna, Austria;2. Department of Pediatrics, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria;1. Earth Observatory of Singapore, 50 Nanyang Avenue, 639798 Singapore, Singapore;2. Lerchenauerstr. 167, D-80935 München, Germany |
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| Abstract: | Influenza epidemics are an important cause of morbidity and mortality throughout the world. Current recommendations from Health Authorities emphasize annual immunization of people who are particularly at risk from an influenza virus infection; however, vaccination of working adults and of school children also has been shown to provide public health benefits. To give it a more advantageous reactogenicity profile than the diethylether-split influenza vaccines available previously, a split virion influenza vaccine has been produced with TritonX-100. In a series of clinical trials, Aventis Pasteur (formerly, Pasteur Mérieux Connaught) tested both the safety and immunogenicity of this TritonX-100-split virion influenza vaccine in 566 subjects (42 children, 296 adults, and 228 elderly adults) during three influenza seasons (1991, 1993, and 1995). The TritonX-100-split virion vaccine was well tolerated: no serious adverse events were recorded during the 21 days following immunization. Among the local reactions observed, mild pain, redness, or induration at the injection site were the most frequently reported. Fever (38·0 to 38·5°C) was noted in five adults or elderly subjects (1%), and in two children (5%). Immunogenicity was determined by measuring serum haemagglutinin antibody titres specific to each vaccine virus strain. In each of the three vaccination campaigns, the TritonX-100-split virion influenza vaccine fulfilled the Notes for Guidance on Harmonization of Requirements for Influenza Vaccines outlined by the Committee for Proprietary Medicinal Products (CPMP) of the European Community for an influenza virus vaccine (i.e., seroprotection, seroconversion, or increase of geometric mean titre) in all age groups. |
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