A phase III, observer-blind, randomised study to evaluate the safety and immunogenicity of one and two administrations of pandemic monovalent (H5N1) influenza vaccine (split virus formulation containi...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-001281-16

A phase III, observer-blind, randomised study to evaluate the safety and immunogenicity of one and two administrations of pandemic monovalent (H5N1) influenza vaccine (split virus formulation containing 15 µg HA and adjuvanted with AS03) in adults aged 18 years and older

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Extrait

The primary objective is to evaluate the safety/reactogenicity of the pandemic influenza vaccine in terms of : •solicited local/general symptoms during 7 days post-vaccination, •unsolicited symptoms during 21 days following the first vaccination and 30 days following the second one •serious adverse events during the entire study period (180 days). •Occurrence of new onset chronic diseases during the entire study period in each group. •Occurrence of medically significant conditions prompting emergency room visits or physician visits that are not related to common diseases or routine visits, during the entire study period in each group


Critère d'inclusion

  • Immunization against (H5N1) influenza disease in subjects aged 18 years and older