During the 6-month follow-up, at least one SAE was reported by 2.8% (35/1272) of the QIV selleck chemical group, and 1.4% (3/213) and 3.2% (7/218) of the TIV-Vic and TIV-Yam groups, respectively (Supplementary Table 1). None of the SAEs were considered
to be vaccine related. This Phase III, randomized, double-blind study of healthy adults aged ≥18 years showed that QIV was immunologically superior versus TIV for the alternate-lineage B strain, and was non-inferior for the influenza strains shared in the QIV and TIVs. HI antibody responses were also shown to be consistent between three lots of QIV, thus demonstrating manufacturing consistency of the candidate vaccine. Our results show that in people aged ≥18 years, QIV offers improved immunogenicity against the additional B strain without affecting antibody responses to existing strains compared with conventional TIVs; therefore, our study supports a switch
from conventional TIV to QIV with the aim of improving protection against influenza B disease. The immunogenicity and safety findings reported for this QIV which was manufactured in Canada are Gemcitabine consistent with a previous report of an inactivated QIV produced by the same company using a different process at facilities in Germany [16]. The results add to the growing evidence in both children and adults which shows that live attenuated and inactivated QIVs provide similar immune responses against shared vaccine strains versus TIV with added protection against the additional B strain [12], [13], unless [14], [15], [16] and [17]. We showed that each of the vaccines elicited strong
HI antibody responses against the A/H1N1 and A/H3N2 vaccine strains, and against B/Brisbane/60/2008 (Victoria) and/or against B/Florida/4/2006 (Yamagata). SCRs and SPRs against each vaccine strain were considered to be high, and immune responses were slightly stronger against influenza A than influenza B strains with QIV and both TIVs. The persistence of antibody responses was assessed six months after vaccination in a sub-cohort of subjects, and whereas immune responses decreased at 6 months in each vaccine group relative to those measured at day 21 after vaccination, they remain notably increased above baseline levels. In the QIV group, antibody persistence at 6 months appeared to be more robust against the influenza B strains with SPRs of 94.9% and 99.6% against B/Victoria and B/Yamagata, respectively, compared with SPRs of 66.5% and 64.6% against A/H1N1 and A/H3N2, respectively. Antibody levels were decreased against the influenza A strains at 6 months post-vaccination, and the clinical significance of this is uncertain. Descriptive analyses were also performed to further assess the immunogenicity of QIV according to age. The median age was 50.0 years (18–91 years) overall, with an equal distribution of subjects aged 18–64 years versus ≥65 years in each group.