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

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-013710-27

A phase III, observer-blind, randomized trial to evaluate the safety and immunogenicity 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 to 60 years

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Extrait

To demonstrate that vaccination with two doses of the H1N1 candidate vaccine (A/California/7/2009 (H1N1)v-like) containing 3.75 µg of HA with AS03A results in an 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 18 to 60 years of age.

Critère d'inclusion

  • Immunization against A/California/7/2009 (H1N1)v-like influenza in male and female subjects aged 18 to 60 years

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