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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.
Biologicals. 2000 Jun; 28(2):95-103.B

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 degrees 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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Authors+Show Affiliations

Lina B
Laboratoire de Virologie, Centre National de Référence de la Grippe (France Sud), Faculté de Médecine Lyon Grange Blanche, France.
Fletcher MA
No affiliation info available
Valette M
No affiliation info available
Saliou P
No affiliation info available
Aymard M
No affiliation info available

MeSH

AdolescentAdultAgedAged, 80 and overAnimalsAntibodies, ViralAntigens, ViralChick EmbryoChildDetergentsHemagglutinin Glycoproteins, Influenza VirusHumansInfluenza A virusInfluenza B virusInfluenza VaccinesMiddle AgedOctoxynolSafetyVaccinationVirion

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article

Language

eng

PubMed ID

10885616

Citation

Lina, B, et al. "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." Biologicals : Journal of the International Association of Biological Standardization, vol. 28, no. 2, 2000, pp. 95-103.
Lina B, Fletcher MA, Valette M, et al. 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. Biologicals. 2000;28(2):95-103.
Lina, B., Fletcher, M. A., Valette, M., Saliou, P., & Aymard, M. (2000). 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. Biologicals : Journal of the International Association of Biological Standardization, 28(2), 95-103.
Lina B, et al. 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. Biologicals. 2000;28(2):95-103. PubMed PMID: 10885616.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Lina,B, AU - Fletcher,M A, AU - Valette,M, AU - Saliou,P, AU - Aymard,M, PY - 2000/7/8/pubmed PY - 2000/10/21/medline PY - 2000/7/8/entrez SP - 95 EP - 103 JF - Biologicals : journal of the International Association of Biological Standardization JO - Biologicals VL - 28 IS - 2 N2 - 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 degrees 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. SN - 1045-1056 UR - https://www.unboundmedicine.com/medline/citation/10885616/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1045-1056(00)90245-8 DB - PRIME DP - Unbound Medicine ER -