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A phase II, randomised, open study to evaluate the immunogenicity and safety of a single or double-dose of the pandemic influenza candidate vaccine split virus formulation adjuvanted with AS03 gi...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-004041-42

A phase II, randomised, open study to evaluate the immunogenicity and safety of a single or double-dose of the pandemic influenza candidate vaccine split virus formulation adjuvanted with AS03 given following a two-administration schedule 21 days apart in adults over 60 years of age

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Extrait

To evaluate the immunogenicity of the H5N1 vaccine administered as a single or double dose in terms of humoral immune response anti-haemagglutinin antibody and neutralizing antibody 21 days after each vaccination. To assess the persistence of antibodies 180 days after the first vaccination with the H5N1 vaccine Refer to Section 10.1 for definition of the primary endpoint.

Critère d'inclusion

  • Immunization against influenza disease during pandemic in subjects over 60 years of age

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