A phase III, open, non-randomized, trial to evaluate the immunogenicity and safety of a two-dose schedule of the A/California/7/2009 (H1N1)v-like candidate vaccine manufactured in Dresden adjuvanted with AS03A, in adults aged 18 years and above

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Extrait

To demonstrate that vaccination with two doses of the H1N1 candidate vaccine (A/California/7/2009 (H1N1)v-like strain) containing 1.9 µg of HA adjuvanted with AS03A results in an Haemagglutination Inhibition (HI) immune response to the vaccine-homologous virus that meets or exceeds the EMEA (CHMP) guidance targets for pandemic vaccine seroconversion rate (SCR), seroprotection rate (SPR), and geometric mean fold rise (GMFR) at 21 days after the second dose of H1N1 vaccine in adults within the 18 to 60 years and above 60 years age strata.

Critère d'inclusion

Immunization against A/California/7/2009 (H1N1)v-like influenza in male and female subjects aged 18 years and above

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Kusajili – Centralise les essais cliniques mondiaux

A phase III, open, non-randomized, trial to evaluate the immunogenicity and safety of a two-dose schedule of the A/California/7/2009 (H1N1)v-like candidate vaccine manufactured in Dresden adjuvanted w...