Vaccine Information: Afluria Quadrivalent (Page 3 of 6)

14.2 Immunogenicity of AFLURIA QUADRIVALENT in Adults and Older Adults Administered by Needle and Syringe

Study 1 was a randomized, double-blind, active-controlled trial conducted in the U.S. in adults aged 18 years of age and older. Subjects received one dose of either AFLURIA QUADRIVALENT (N=1691) or one of two formulations of comparator trivalent influenza vaccine (AFLURIA, TIV-1 N=854 or TIV-2 N=850) each containing an influenza type B virus that corresponded to one of the two B viruses in AFLURIA QUADRIVALENT (a type B virus of the Yamagata lineage or a type B virus of the Victoria lineage, respectively).

Post-vaccination immunogenicity was evaluated on sera obtained 21 days after administration of a single dose of AFLURIA QUADRIVALENT or TIV comparator. The co-primary endpoints were HI Geometric Mean Titer (GMT) ratios (adjusted for baseline HI titers) and the difference in seroconversion rates for each vaccine strain, 21 days after vaccination. Pre-specified non-inferiority criteria required that the upper bound of the 2-sided 95% CI of the GMT ratio (TIV/AFLURIA QUADRIVALENT) did not exceed 1.5 and the upper bound of the 2-sided 95% CI of the seroconversion rate difference (TIV minus AFLURIA QUADRIVALENT) did not exceed 10.0% for each strain.

Serum HI antibody responses to AFLURIA QUADRIVALENT were non-inferior to both TIVs for all influenza strains for subjects 18 years of age and older. Additionally, non-inferiority was demonstrated for both endpoints in both age sub-groups, adults aged 18 through 64 years and 65 years and older, for all strains (Table 7). Superiority of the immune response to each of the influenza B strains contained in AFLURIA QUADRIVALENT was shown relative to the antibody response after vaccination with TIV formulations not containing that B lineage strain for subjects 18 years of age and older. Superiority against the alternate B strain was also demonstrated for each of the influenza B strains in both age sub-groups; 18 through 64 years and 65 years and older. Post-hoc analyses of immunogenicity endpoints by gender did not demonstrate meaningful differences between males and females. The study population was not sufficiently diverse to assess differences between races or ethnicities.

Table 7: Post-Vaccination HI Antibody GMTs, Seroconversion Rates, and Analyses of Non-Inferiority of AFLURIA QUADRIVALENT Relative to Trivalent Influenza Vaccine (TIV) by Age Cohort (Study 1)a
Post-vaccination GMT GMT Ratio b Seroconversion % c Difference Met both pre-defined non-inferiority criteria? d
Strain AFLURIA Quadrivalent Pooled TIV or TIV-1(B Yamagata) or TIV-2(B Victoria) Pooled TIV or TIV-1 or TIV-2 over AFLURIA Quadrivalent (95% CI) AFLURIA Quadrivalent N=1691 Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) Pooled TIV or TIV-1 or TIV-2 minusAFLURIA Quadrivalent (95% CI)

Abbreviations: CI, confidence interval; GMT, geometric mean titer.

a NCT02214225

b GMT ratio was computed after fitting a multi-variable model on the post-vaccination titers including sex, vaccination history, pre-vaccination HI titers and other factors.

c Seroconversion rate is defined as a 4-fold increase in post-vaccination HI antibody titer from pre-vaccination titer 1:10 or an increase in titer from < 1:10 to ≥ 1:40.

d Non-inferiority (NI) criterion for the GMT ratio: upper bound of 2-sided 95% CI on the GMT ratio of Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/AFLURIA Quadrivalent should not exceed 1.5. NI criterion for the SCR difference: upper bound of 2-sided 95% CI on the difference between SCR Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus AFLURIA Quadrivalent should not exceed 10%.

e Pooled TIV/AFLURIA Quadrivalent

f TIV-1 (B Yamagata)/AFLURIA Quadrivalent

g TIV-2 (B Victoria)/AFLURIA Quadrivalent

h Pooled TIV – AFLURIA Quadrivalent

i TIV-1 (B Yamagata) — AFLURIA Quadrivalent

j TIV-2 (B Victoria) — AFLURIA Quadrivalent

18 through 64 years AFLURIA Quadrivalent N=835, Pooled TIV N=845, TIV-1 N=424, TIV-2 N=421
A(H1N1) 432.7 402.8 0.93 e (0.85, 1.02) 51.3 49.1 -2.1 h (-6.9, 2.7) Yes
A(H3N2) 569.1 515.1 0.91 e (0.83, 0.99) 56.3 51.7 -4.6 h (-9.4, 0.2) Yes
B/Massachusetts/2/2012(B Yamagata) 92.3 79.3 0.86 f (0.76, 0.97) 45.7 41.3 -4.5 i (-10.3, 1.4) Yes
B/Brisbane/60/2008(B Victoria) 110.7 95.2 0.86 g (0.76, 0.98) 57.6 53.0 -4.6 j (-10.5, 1.2) Yes
≥ 65 years AFLURIA Quadrivalent N=856, Pooled TIV N=859, TIV-1 N=430, TIV-2 N=429
A(H1N1) 211.4 199.8 0.95 e (0.88, 1.02) 26.6 26.4 -0.2 h (-5.0, 4.5) Yes
A(H3N2) 419.5 400.0 0.95 e (0.89, 1.02) 25.9 27.0 1.1 h (-3.7, 5.8) Yes
B/Massachusetts/2/2012(B Yamagata) 43.3 39.1 0.90 f (0.84, 0.97) 16.6 14.4 -2.2 i (-8.0, 3.6) Yes
B/Brisbane/60/2008(B Victoria) 66.1 68.4 1.03 g (0.94, 1.14) 23.5 24.7 1.2 j (-4.6, 7.0) Yes

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