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A phase III, observer-blind, randomized, study in adults aged between 18 and 60 years to assess the immunological equivalence of the Quebec-manufactured A/California/7/2009 (H1N1)v-like antigen adjuva...

Update Il y a 4 ans
Reference: EUCTR2009-014419-11

A phase III, observer-blind, randomized, study in adults aged between 18 and 60 years to assess the immunological equivalence of the Quebec-manufactured A/California/7/2009 (H1N1)v-like antigen adjuvanted with AS03A as compared to the Dresden-manufactured A/California/7/2009 (H1N1)v-like antigen adjuvanted with AS03A

Woman and Man

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Extract

To assess the immunological equivalence (in terms of vaccine-homologous virus H1N1 HI antibody GMTs) of the Quebec-manufactured A/California/7/2009 (H1N1)v-like vaccine adjuvanted with AS03A and the Dresden-manufactured A/California/7/2009 (H1N1)v-like vaccine adjuvanted with AS03A, 21 days after the first vaccination in healthy subjects aged 18 to 60 years. Criteria for equivalence: Immunological equivalence will be demonstrated if the limits of two-sided 95% confidence interval for the GMT ratio (Flu D-PAN H1N1 vaccine over Flu Q-PAN H1N1 vaccine) in terms of HI antibody titre against A/California/7/2009 (H1N1)v-like strain are within the 0.5 - 2.0 interval.

Inclusion criteria

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

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