Ten Years of Experience with the Trivalent Split-Influenza Vaccine, Fluarix???

Immunologic non-inferiority of a newly licensed inactivated trivalent influenza vaccine versus an established vaccine

“…The newly-licensed vaccine achieved CBER criteria for seroconversion and seroprotection rates for all three vaccine strains in the whole study population (≥18 years) and in the elderly (≥65 years). With the completion of this study and a placebo-controlled study of the efficacy of Seroconversion and seroprotection rates in the whole study population (≥18 years) with the newly-licensed vaccine in this study were consistent with those observed in European studies conducted over 10 years 22 and in the previous placebo-controlled study of the newly-licensed vaccine in the US. 19 In addition to demonstrating non-inferiority to an established vaccine, Center for Biological Evaluation and Research (CBER) licensing criteria require that the lower 95% CIs for seroconversion rate and seroprotection rate are ≥40% and ≥70%, respectively, for all three viral strains in adults <65 years of age.…”

Effect on Cellular and Humoral Immune Responses of the AS03 Adjuvant System in an A/H1N1/2009 Influenza Virus Vaccine Administered to Adults during Two Randomized Controlled Trials

“…Assessment of the humoral immune response. Serum samples were tested in a validated HI microtiter assay using chicken erythrocytes, as previously described (19), with the A/California/7/2009 vaccine strain used as an antigen.…”

Immunogenicity and safety of a novel AS03A-adjuvanted H1N1 2009 pandemic influenza vaccine in adults in Japan

“…Blood samples collected before vaccination (Day 0), post-Dose 1 (Day 21) and post-Dose 2 (Day 42) were analyzed at GSK Biologicals Central laboratory, Dresden, Germany, using a validated in-house microtitre Hemagglutination Inhibition (HI) assay [cut-off: ≥1:10], with chicken erythrocytes as previously described. 31 The A/ California/7/2009 vaccine strain was used as the antigen strain.…”