Influenza A (H5N1) pandemic prototype vaccine Fluval^®

References

• Ungchusak K, Auewarakul P, Dowell SF et al. Probable person-to-person transmission of avian influenza A (H5N1). N. Engl. J. Med.352(4), 333–340 (2005).
   PubMed Web of Science ®Google Scholar
• Yang Y, Halloran ME, Sugimoto JD, Longini IM Jr. Detecting human-to-human transmission of avian influenza A (H5N1). Emerg. Infec. Dis.13(9), 1348–1353 (2007).
   PubMed Web of Science ®Google Scholar
• Poland GA. Vaccines against avian influenza – a race against time. N. Engl. J. Med.354(13), 1411–1413 (2006).
   PubMed Web of Science ®Google Scholar
• de Jong MD, Tran TT, Truong HK et al. Oseltamivir resistance during treatment of influenza A (H5N1) infection. N. Engl. J. Med.353(25), 2667–2672 (2005).
   PubMed Web of Science ®Google Scholar
• Carrat F, Flahault A. Influenza vaccine: The challenge of antigenic drift. Vaccine25(39–40), 6852–6862 (2007).
   PubMed Web of Science ®Google Scholar
• Lu X, Edwards LE, Desheva JA et al. Cross-protective immunity in mice induced by live-attenuated or inactivated vaccines against highly pathogenic influenza A (H5N1) viruses. Vaccine24(44–46), 6588–6593 (2006).
   PubMed Web of Science ®Google Scholar
• Girard M, Palkonyay L, Kieny MP. Report of the 4th meeting on the ‘Evaluation of pandemic influenza prototype vaccines in clinical trials’ WHO, Geneva, Switzerland, 14–15 February 2008. Vaccine26(39), 4975–4977 (2008).
   PubMedGoogle Scholar
• Takatsy G. Purified precipitated virus obtained by a new simple method. Acta Med. Acad. Sci. Hung.3(2), 185–191 (1952).
   PubMedGoogle Scholar
• European Committee for Proprietary Medicinal Products. Note for guidance on harmonization of requirements for influenza vaccines, March 1997 (CPMP/BWP/214/96). EMEA, 12 March (1997).
   Google Scholar
• Vajo Z, Kosa L, Szilvasy I et al. Yearly licensing studies from 1997–2007 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. Viruses2(6), 211–218 (2008).
   PubMed Web of Science ®Google Scholar
• European Committee for Proprietary Medicinal Products. Guideline on dossier structure and content for pandemic influenza vaccine marketing authorisation application (CPMP/VEG/4717/03). EMEA, 5 April (2004).
   Google Scholar
• Nicolson C, Major D, Wood JM, Robertson JS. Generation of influenza vaccine viruses on Vero cells by reverse genetics: an H5N1 candidate vaccine strain produced under a quality system. Vaccine23(22), 2943–2952 (2005).
   PubMed Web of Science ®Google Scholar
• Wood JM, Schild GC, Newman RW, Seagroatt V. 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(3), 237–247 (1977).
   PubMedGoogle Scholar
• European Directoriate for the Quality Medicines. European Pharmacopia, 5.8 CD, 7/2007 Strasbourg, France, 3406–3407 (2007).
   Google Scholar
• Vajo Z, Kosa L, Visontay I et al. Inactivated whole virus influenza A (H5N1) vaccine. Emerg. Infec. Dis.13(5), 807–808 (2007).
   PubMed Web of Science ®Google Scholar
• Vajo Z, Kosa L, Szilvasy I et al. Safety and immunogenicity of a prepandemic influenza A (H5N1) vaccine in children. Pediatr. Infect. Dis. J.27(12), 1052–1056 (2008).
   PubMed Web of Science ®Google Scholar
• Giesecke J, Sellwood C, Van-Tam J. Expert advisory groups on human H5N1 vaccines. European Centre for Disease Control and Prevention, Stockholm, Sweden, March 2007.
   Google Scholar
• Fazekas G, Martosne-Mendi R, Jankovics I, Szilvasy I, Vajo Z. Cross-reactive immunity in adult and elderly patients against clade 2 influenza A H5N1 virus strains induced by Fluval, a reverse genetic-derived adjuvanted H5N1 clade 1 prototype pandemic influenza vaccine. Clin. Vaccine Immunol.16, 437–443 (2008).
   PubMedGoogle Scholar
• Nicholson KG, Tyrrell DAJ, Harrison P et al. Clinical studies of monovalent inactivated whole virus and subunit A/USSR/77 (H1N1) vaccine: serological responses and clinical reactions. J. Biol. Stand.7(2), 123–136 (1979).
   PubMedGoogle Scholar
• Treanor JJ, Campbell JD, Zangwill KM, Rowe T, Wolff M. Safety and immunogenicity of an inactivated subvirion influenza A (H5N1) vaccine. N. Engl. J. Med.354(13), 1343–1351 (2006).
   PubMed Web of Science ®Google Scholar
• Bresson JL, Perronne C, Launay O et al. Safety and immunogenicity of an inactivated split-virion influenza A/Vietnam/1194/2004(H5N1) vaccine: Phase I randomised trial. Lancet367(9523), 1657–1664 (2006).
   PubMed Web of Science ®Google Scholar
• Leroux-Roels I, Borkowski A, Vanwolleghem T et al. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial. Lancet370(9587), 580–589 (2007).
   PubMed Web of Science ®Google Scholar
• Lin J, Zhang J, Dong X et al. Safety and immunogenicity of an inactivated adjuvanted whole- virion influenza A (H5N1) vaccine: a Phase I randomized controlled trial. Lancet368(9540), 991–997 (2006).
   PubMed Web of Science ®Google Scholar
• Ehrlich HJ, Müller M, Oh HM et al.; Baxter H5N1 Pandemic Influenza Vaccine Clinical Study Team. A clinical trial of a whole-virus H5N1 vaccine derived from cell culture. N. Engl. J. Med.358(24), 2573–2584 (2008).
   PubMed Web of Science ®Google Scholar
• Nicholson KG, Colegate AE, Podda A et al. Safety and antigenicity of non-adjuvanted and MF59-adjuvanted influenza A/Duck/Singapore/97 (H5N3) vaccine: a randomised trial of two potential vaccines against H5N1 influenza. Lancet357(9272), 1937–1943 (2001).
   PubMed Web of Science ®Google Scholar
• Bernstein DI, Edwards KM, Dekker CL et al. Effects of adjuvants on the safety and immunogenicity of an avian influenza H5N1 vaccine in adults. J. Infect. Dis.197(5), 667–675 (2008).
   PubMed Web of Science ®Google Scholar
• Rümke HC, Bayas JM, de Juanes JR et al. Safety and reactogenicity profile of an adjuvanted H5N1 pandemic candidate vaccine in adults within a Phase III safety trial. Vaccine26(19), 2378–2388 (2008).
   PubMed Web of Science ®Google Scholar
• Nichol KL, Treanor JJ. Vaccines for seasonal and pandemic influenza. J. Infect. Dis.194(Suppl. 2), S111–S118 (2006).
   PubMed Web of Science ®Google Scholar
• Engler RJ, Nelson MR, Klote MM et al.; Walter Reed Health Care System Influenza Vaccine Consortium. Half- vs full-dose trivalent inactivated influenza vaccine (2004–2005): age, dose, and sex effects on immune responses. Arch. Intern. Med.168(22), 2405–2414 (2008).
   PubMedGoogle Scholar
• Ferguson NM, Cummings DAT, Fraser C, Cajka JC, Cooley PC, Burke DS. Strategies for mitigating an influenza pandemic Nature442(7101), 448–452 (2006).
   PubMed Web of Science ®Google Scholar
• Friede M, Serdobova I, Palkonyay L, Kieny MP. Technology transfer hub for pandemic influenza vaccine. Vaccine27(5), 631–632 (2009).
   PubMed Web of Science ®Google Scholar
• Murakami S, Iwasa A, Iwatsuki-Horimoto K et al. Cross-clade protective immunity of H5N1 influenza vaccines in a mouse model. Vaccine26(50), 6398–6404 (2008).
   PubMed Web of Science ®Google Scholar
• Nolan TM, Richmond PC, Skeljo MV et al. 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. Vaccine26(33), 4160–4167 (2008).
   PubMed Web of Science ®Google Scholar
• Nolan T, Richmond PC, Formica NT et al. Safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in infants and children. Vaccine26(50), 6383–6391 (2008).
   PubMed Web of Science ®Google Scholar
• Stephenson I, Bugarini R, Nicholson KG et al. Cross-reactivity to highly pathogenic avian influenza H5N1 viruses after vaccination with nonadjuvanted and MF59-adjuvanted influenza A/Duck/Singapore/97 (H5N3) vaccine: a potential priming strategy. J. Infect. Dis.191(8), 1210–1215 (2005).
   PubMed Web of Science ®Google Scholar
• Zangwill KM, Treanor JJ, Campbell JD, Noah DL, Ryea J. Evaluation of the safety and immunogenicity of a booster (third) dose of inactivated subvirion H5N1 influenza vaccine in humans. J. Infect. Dis.197(4), 580–583 (2008).
   PubMed Web of Science ®Google Scholar