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A phase II, randomized, observer blind study to evaluate the safety and immunogenicity of three different vaccination schedules employing two formulations of the monovalent A/California/7/2009 (H1N1)v...

Update Il y a 4 ans
Reference: EUCTR2009-016268-35

A phase II, randomized, observer blind study to evaluate the safety and immunogenicity of three different vaccination schedules employing two formulations of the monovalent A/California/7/2009 (H1N1)v-like candidate vaccine adjuvanted with AS03 and the monovalent A/California/7/2009 (H1N1)v-like candidate vaccine formulated without adjuvant in subjects aged 10 to less than 18 years

Woman and Man

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Extract

To assess whether vaccination with monovalent A/California/7/2009 (H1N1)v-like vaccine (each treatment group) results in an immune response to the vaccine-homologous virus that meets or exceeds the CHMP guidance targets for pandemic vaccine seroconversion rate (SCR), rate of induction of vaccine-homologous reciprocal hemagglutination inhibition (HI) titers greater than or equal to 40 (potential seroprotection rate [SPR]) and geometric mean fold rise (GMFR) 21 days after the first dose of H1N1 vaccine in children 10 to < 18 years of age.

Inclusion criteria

  • Immunization of healthy children aged 10 to less than 18 years against A/California/7/2009 (H1N1)v-like influenza

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