TRANSFORM THE WAY YOU THINK ABOUT INFLUENZA PROTECTION

^aClinical efficacy was assessed in a multinational, placebo-controlled trial involving 11,404 adults aged 18 through 49 years receiving FLUCELVAX^® (influenza vaccine), comparator, or placebo. In a multinational, randomized, observer-blind, placebo-controlled trial, the clinical efficacy and safety of FLUCELVAX was assessed during the 2007-2008 influenza season in adults aged 18 through 49 years. A total of 11,404 subjects were enrolled to receive FLUCELVAX (N=3828), AGRIFLU (N=3676), or placebo (N=3900) in a 1:1:1 ratio.

^a Seroconversion rate is defined as the percentage of subjects with either a prevaccination hemagglutinin inhibition (HI) titer <1:10 and postvaccination HI titer ≥1:40 or with a prevaccination HI titer ≥1:10 and a minimum 4-fold increase in postvaccination HI antibody titer. Immunogenicity success criteria were met if the lower limit of the 95% confidence interval (CI) of the percentage of subjects with HI titer ≥140 is ≥70% and the lower limit of the 95% CI of the percentage of subjects with seroconversion is ≥40%^1.
b Per protocol set: All subjects in Full Analysis Set, immunogenicity population, who have correctly received the assigned vaccine, have no major protocol deviations leading to exclusion as defined prior to unblinding/analysis and are not excluded due to other reasons defined prior to unblinding or analysis.^1
c A/H1N1: 95% CI, 69-75; A/H3N2: 95% CI, 44-50; B1: 95% CI, 63-69; B2: 95% CI, 70-76.¹

ⁱ HI GMT = hemagglutination inhibition geometric mean titer.
^j The comparator vaccines for non inferiority comparisons were 2 formulations of FLUCELVAX^® (influenza vaccine), each containing a different influenza B strain. TIV1c contained A/H1N1, A/H3N2, and B1 and TIV2c contained A/H1N1, A/H3N2, and B2.
The immunogenicity of FLUCELVAX QUADRIVALENT was evaluated in 2 randomized, double-blind, controlled studies conducted in the United States in adults 18 years and older (Study 1) and children 4 through 17 years of age (Study 2).¹ In Study 1, subjects received FLUCELVAX QUADRAVALENT or 1 of the 2 formulations of comparator trivalent influenza vaccine (FLUCELVAX QUADRIVALENT [N = 1334], TIV1c [N = 669]).1, or TIV2c [N=669]).¹ In Study 2, 1159 subjects received FLUCELVAX QUADRIVALENT. The immune response to each of the vaccines was assessed 21 days after vaccination.^1,m
k A/H1N1: 95% CI, 0.9-1.11; A/H3N2: 95% CI, 0.9-1.11; B1: 95% CI, 0.8-1.0; B2: 95% CI .0.9-1.0.^g Seroconversion rate is defined as the percentage of subjects with either a prevaccination HI titer <1:10 and postvaccination HI titer ≥140 or with a prevaccination HI titer ≥1:10 and a minimum 4-fold increase in postvaccination HI antibody titer.^h Analyses were performed on Day 50.