TY - JOUR T1 - Immunogenicity of AS03-adjuvanted and non-adjuvanted trivalent inactivated influenza vaccines in elderly adults: A Phase 3, randomized trial and post-hoc correlate of protection analysis. AU - Ruiz-Palacios,Guillermo M, AU - Leroux-Roels,Geert, AU - Beran,Jiri, AU - Devaster,Jeanne-Marie, AU - Esen,Meral, AU - Launay,Odile, AU - McElhaney,Janet E, AU - van Essen,Gerrit A, AU - Benoit,Anne, AU - Claeys,Carine, AU - Dewé,Walthère, AU - Durand,Christelle, AU - Duval,Xavier, AU - Falsey,Ann R, AU - Feldman,Gregory, AU - Galtier,Florence, AU - Gervais,Pierre, AU - Hwang,Shinn-Jang, AU - McNeil,Shelly, AU - Richardus,Jan Hendrik, AU - Trofa,Andrew, AU - Oostvogels,Lidia, AU - ,, PY - 2016/10/4/pubmed PY - 2017/10/5/medline PY - 2016/10/4/entrez KW - AS03 KW - correlates of protection KW - immunogenicity KW - older KW - seasonal influenza KW - vaccine SP - 3043 EP - 3055 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 12 IS - 12 N2 - In this study we describe the immunogenicity results from a subset of older people (N = 5187) who participated in a Phase 3 randomized, observer-blinded trial of AS03-TIV versus TIV (Fluarix™) (ClinicalTrials.gov, NCT00753272). Participants received one dose of AS03-TIV or TIV in each study year and antibody titers against the vaccine strains were assessed using hemagglutination-inhibition (HI) assay at 21 d and 180 d post-vaccination in each vaccine group in the 2008/09 (Year 1) and 2009/10 (Year 2) influenza seasons. Manufacturing consistency of 3 lots of AS03-TIV for HI antibody responses in Year 1 was a co-primary objective. In a post-hoc analysis, a statistical regression model included 4830 subjects in whom immunogenicity and laboratory-confirmed attack rate data were available; the analysis was performed to assess HI antibody titers against A/H3N2 as a correlate of protection for laboratory-confirmed A/H3N2 influenza. AS03-TIV and TIV elicited strong HI antibody responses against each vaccine strain 21 d post-vaccination in both years. The manufacturing consistency of 3 lots of AS03-TIV was demonstrated. In both years and each vaccine group, HI antibody responses were lower for A/H1N1 than the other vaccine strains. Day 180 seroconversion rates (proportion with ≥4-fold increase in titer compared with pre-vaccination titer) in Year 1 in the AS03-TIV and TIV groups, respectively, were 87.7% and 74.1% for A/H3N2, 69.7% and 59.6% for influenza B, and 58.3% and 47.4% for A/H1N1. The post-hoc statistical model based on A/H3N2 attack rates and HI antibody titers estimated that a 4-fold increase in post-vaccination titers against A/H3N2 was associated with a 2-fold decrease in the odds of A/H3N2 infection. SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/27690762/Immunogenicity_of_AS03_adjuvanted_and_non_adjuvanted_trivalent_inactivated_influenza_vaccines_in_elderly_adults:_A_Phase_3_randomized_trial_and_post_hoc_correlate_of_protection_analysis_ DB - PRIME DP - Unbound Medicine ER -