A phase II, randomized, open, partially controlled study to evaluate the safety and immunogenicity of different formulations of a pandemic influenza vaccine candidate (split virus formulation adjuvant...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-001168-22

A phase II, randomized, open, partially controlled study to evaluate the safety and immunogenicity of different formulations of a pandemic influenza vaccine candidate (split virus formulation adjuvanted with AS03) given following a two-administration schedule (21 days apart) in children between 3 and 9 years of age

Femme et Homme

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Extrait

•To evaluate the humoral immune response induced by the H5N1 vaccine candidate in terms of anti-haemagglutinin antibody titer. •To evaluate the safety and reactogenicity of the H5N1 vaccine candidate in terms of solicited local and general adverse events, unsolicited adverse events and serious adverse events


Critère d'inclusion

  • Immunization of healthy children aged 3-9 years against (H5N1) influenza