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Five Spanish hospitals in international phase III trial with H5N1 influenza pandemic vaccine

Both governments and the scientific community are mobilised to face the threat of a possible pandemic provoked by avian influenza. Whereas there is no need to alarm the population, we must design tools in order to fight influenza in case it develops. According to historical data and to the high genetic variability of influenza virus, the development of this pandemic is only a matter of time and that the appropriate circumstances are given. The H5N1 virus, which affects the European fowl, has already evidenced that it could successfully break the human barrier. This is the reason why H5N1 is the best candidate to establish the bases of the development of pandemic vaccines. Five large national hospitals will participate in the first study with a H5N1 influenza pandemic vaccine held in Spain. Our specialists are working in an international study, with the participation of 7 countries, in order to assess the possible side effects and immunogenicity of this vaccine, developed by GlaxoSmithKline (GSK), in individuals over 18 years.

A total of 5,052 individuals will participate in this study, 1,500 of which will be recruited in Spain. The five Spanish centres are Hospital 12 de Octubre, Hospital Clnico San Carlos and Hospital de La Princesa in Madrid, and the centres Hospital Vall d'Hebrn and Hospital Clnic in Barcelona. People participating in the study will be randomly separated into two groups: 75% will receive two doses of influenza vaccine, and 25% will receive a dose of conventional influenza vaccine and a dose of placebo. The second dose will be administrated after 21 days after the first medical examination, and during the study, two more examinations will have place (days 43 and 180) and a telephone check (day 51). In 10% of volunteers, blood tests will be made in order to analyse the immune response triggered by the vaccine. Furthermore, participants will fill in a monitoring card during the week after the administration of each dose, where the potential
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Contact: lex Argem
aargemi@clinic.ub.es
34-93-227-5700
IDIBAPS - Institut d'Investigacions Biomdiques August Pi i Sunyer
4-May-2006


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