Safety and immunogenicity of a 2009 pandemic influenza A H1N1 vaccine when administered alone or simultaneously with the seasonal influenza vaccine for the 2009–10 influenza season: a multicentre, randomised controlled trial

The Lancet - Tập 375 - Trang 49-55 - 2010
Zoltan Vajo1, Ferenc Tamas2, Laszlo Sinka3, Istvan Jankovics4
1University of Debrecen, Medical and Health Sciences Centre, Debrecen, Hungary
2State Primary Care Centre, Pilosvorosvar, Hungary
3State Primary Care Centre, Veszprem, Hungary
4National Centre for Epidemiology, Budapest, Hungary

Tài liệu tham khảo

Ginsberg, 2009, Swine influenza A (H1N1) infection in two children—Southern California, March–April 2009, MMWR Morb Mortal Wkly Rep, 58, 400 WHO WHO Vajo, 2007, Inactivated whole virus influenza A (H5N1) vaccine, Emerg Infect Dis, 13, 807, 10.3201/eid1305.061248 Fazekas, 2009, Clin Vaccine Immunol, 16, 437, 10.1128/CVI.00327-08 Vajo, 2008, Safety and immunogenicity of a prepandemic influenza A (H5N1) vaccine in children, Pediatr Infect Dis J, 27, 1052, 10.1097/INF.0b013e3181861dd7 Vajo, 2008, Yearly licensing studies from 1997 to 2007 of the inactivated whole virus seasonal influenza vaccine fluval—a useful approach to pandemic vaccine development even in less well developed countries?, Influenza Other Respir Viruses, 2, 211, 10.1111/j.1750-2659.2008.00055.x WHO Wood, 1977, An improved single-radial-immunodiffusion technique for the assay of influenza haemagglutinin antigen: application for potency determinations of inactivated whole virus and subunit vaccines, J Biol Stand, 5, 237, 10.1016/S0092-1157(77)80008-5 European Directoriate for the Quality Medicines, 2007, European Pharmacopia, 5.8 CD, 7/2007, Strasbourg: European Directoriate for the Quality Medicines, 3406 European Medicines Agency Klimov, 2003 European Committee for Proprietary Medicinal Products, 1997 European Centre for Disease Prevention and Control US Food and Drug Administration Leroux-Roels, 2007, Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial, Lancet, 370, 580, 10.1016/S0140-6736(07)61297-5 Ehrlich, 2008, A clinical trial of a whole-virus H5N1 vaccine derived from cell culture, N Engl J Med, 358, 2573, 10.1056/NEJMoa073121 Nolan, 2008, Phase I and II randomised trials of the safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in healthy adults, Vaccine, 26, 4160, 10.1016/j.vaccine.2008.05.077 Vajo, 2009, Influenza A (H5N1) pandemic prototype vaccine Fluval, Expert Rev Vaccines, 8, 619, 10.1586/erv.09.25 Greenberg, 2009, Response after one dose of a monovalent influenza A (H1N1) 2009 vaccine—preliminary report, N Engl J Med, 10.1056/NEJMoa0907413 Clark, 2009, Trial of influenza A (H1N1) 2009 monovalent MF59-adjuvanted vaccine—preliminary report, N Engl J Med, 10.1056/NEJMoa0907650 Voordouw, 2004, Annual revaccination against influenza and mortality risk in community-dwelling elderly persons, JAMA, 292, 2089, 10.1001/jama.292.17.2089 Dennis, 2006, Flu-vaccine makers toil to boost supply, Nature, 440, 1099, 10.1038/4401099a Profeta, 1980, Comparison between killed subunit influenza vaccines and whole virion preparations: study of reactions and protective efficacy in children and adults, Boll Ist Sieroter Milan, 58, 457 Katz, 2009, Serum cross-reactive antibody response to a novel influenza A (H1N1) virus after vaccination with seasonal influenza vaccine, MMWR Morb Mortal Wkly Rep, 58, 521