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. 2023 Sep 26;11(10):1528.
doi: 10.3390/vaccines11101528.

Immunogenicity and Safety of MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared with a Nonadjuvanted, Quadrivalent Influenza Vaccine in Adults 50-64 Years of Age

Airi Poder  1 , Janine Oberije  2 , Jay Meyer  3 , Peter Heymer  4 , Deborah Molrine  5 , Eve Versage  5 , Leah Isakov  5 , Qiuhong Zhang  6 , Matthew Hohenboken  5
Affiliations

Immunogenicity and Safety of MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared with a Nonadjuvanted, Quadrivalent Influenza Vaccine in Adults 50-64 Years of Age

Airi Poder et al. Vaccines (Basel). .

Abstract

Adults aged 50-64 years have a high incidence of symptomatic influenza associated with substantial disease and economic burden each year. We conducted a randomized, controlled trial to compare the immunogenicity and safety of an adjuvanted quadrivalent inactivated influenza vaccine (aIIV4; n = 1027) with a nonadjuvanted standard dose IIV4 (n = 1017) in this population. Immunogenicity was evaluated on Days 22, 181, and 271. On Day 22, upper limits (UL) of 95% confidence intervals (CI) for geometric mean titer (GMT) ratios (IIV4/aIIV4) were <1.5 and 95% CI ULs for the difference in seroconversion rate (SCR IIV4 - aIIV4) were <10% for all four vaccine strains, meeting primary endpoint noninferiority criteria. Protocol-defined superiority criteria (95% CI ULs < 1.0) were also met for A(H1N1) and A(H3N2). Immune responses following aIIV4 vaccination were more pronounced in persons with medical comorbidities and those not recently vaccinated against influenza. Safety data were consistent with previous studies of MF59 adjuvanted seasonal and pandemic influenza vaccines. These findings support the immunological benefit of aIIV4 for persons aged 50-64 years, especially those with comorbidities.

Keywords: adjuvanted influenza vaccine; age 50–64 years; chronic medical condition; influenza; middle-aged adults.

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Conflict of interest statement

A.P, J.M. and P.H. report support for this trial funded by CSL Seqirus. J.O., D.M., E.V., L.I., Q.Z. and M.H. are employees of CSL Seqirus.

Figures

Figure 1
Figure 1
GMT ratios and SCR differences on Day 22. Blue diamonds represent the point estimates and cross-hatched lines the 95% CIs. (a) Noninferiority analysis in the PPS immunogenicity population. Noninferiority bounds are shown by solid red lines. (b) Superiority analysis in the FAS immunogenicity population. Superiority bound shown by solid red line. Abbreviations: aIIV4—adjuvanted quadrivalent inactivated influenza vaccine; CI—confidence interval; FAS—full analysis set; GMT—geometric mean ratio; IIV4—nonadjuvanted quadrivalent inactivated influenza vaccine; PPS—per protocol set; SCR—seroconversion rate.
Figure 2
Figure 2
Day 22 GMT ratios (IIV4/aIIV4) by age (a), vaccination history (b), and comorbidity risk (c) subgroups (FAS Immunogenicity population). Abbreviations: aIIV4—adjuvanted quadrivalent inactivated influenza vaccine; CI—confidence interval; FAS—full analysis set; GMT—geometric mean ratio; IIV4—nonadjuvanted quadrivalent inactivated influenza vaccine. A GMT ratio <1 favors aIIV4.
Figure 2
Figure 2
Day 22 GMT ratios (IIV4/aIIV4) by age (a), vaccination history (b), and comorbidity risk (c) subgroups (FAS Immunogenicity population). Abbreviations: aIIV4—adjuvanted quadrivalent inactivated influenza vaccine; CI—confidence interval; FAS—full analysis set; GMT—geometric mean ratio; IIV4—nonadjuvanted quadrivalent inactivated influenza vaccine. A GMT ratio <1 favors aIIV4.
Figure 3
Figure 3
Percentage of subjects reporting solicited local (a) and systemic (b) adverse events (AE). Numbers at the top of the bars represent percentage of subjects reporting event of any severity grade; numbers within or at the bottom of the bars represent percentage reporting event as severe.
See this image and copyright information in PMC

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