FLUCELVAX QUADRIVALENT Rx

Efficacy against Culture-Confirmed Influenza

Study 4

• The efficacy experience with Flucelvax is relevant to Flucelvax Quadrivalent.

• The multinational (US, Finland, and Poland), randomized, observer-blind, placebo-controlled trial evaluated the efficacy and safety of Flucelvax during the 2007-2008 influenza season in 11,404 adults 18 through 49 years of age. Patients received either Flucelvax, Agriflu, or placebo. 

• Flucelvax efficacy was assessed by the prevention of culture-confirmed symptomatic influenza illness caused by viruses antigenically matched to those in the vaccine and prevention of influenza illness caused by all influenza viruses compared to placebo.

• Vaccine efficacy of Flucelvax against culture-confirmed influenza caused by antigenically matched strains was 83.8%. The vaccine efficacy of Flucelvax against all culture-confirmed influenza was 69.5%.

• Vaccine efficacy of Flucelvax against culture-confirmed influenza by influenza viral subtype was:

• Antigenically Matched Strains – A/H3N2: N/A

• Antigenically Matched Strains – A/H1N1: 88.2%

• Antigenically Matched Strains – B: N/A

• All Culture-Confirmed Influenza – A/H3N2: 75.6%

• All Culture-Confirmed Influenza – A/H1N1: 89.3%

• All Culture-Confirmed Influenza – B: 49.9%

Efficacy of Flucelvax Quadrivalent in Children and Adolescents 2 through 17 Years of Age

Study 2

• The multinational, randomized, non-influenza vaccine comparator-controlled efficacy, immunogenicity and safety study evaluated the absolute efficacy of Flucelvax Quadrivalent in 4514 children and adolescents 2 through 17 years of age. Patients were randomly assigned to receive either Flucelvax Quadrivalent or a non-influenza comparator vaccine (meninogococcal [groups A, C, Y, and W-135] oligosaccharide diphtheria CRM197 conjugate).

• Children 2 through 8 years of age received either 1 or 2 doses (separated by 4 weeks) of Flucelvax Quadrivalent or comparator vaccine depending on the subject’s prior influenza vaccination history.

• Children and adolescents 9 through 17 years of age received a single dose of Flucelvax Quadrivalent or non-influenza comparator vaccine.

• The overall vaccine efficacy for the entire study population (2 through 17 years) was 54.6% (95% CI 45.7 – 62.1), which met predefined success criteria. In addition, vaccine efficacy was 50.5% (95% CI 38.4 – 60.2) in children 2 through 8 years of age and 61.9% (95% CI 47.4 – 72.3) in those 9 through 17 years of age. 

Immunogenicity of Flucelvax Quadrivalent in Adults 18 years of age and above

Study 3

• The randomized, double-blind, controlled study evaluated the immunogenicity of Flucelvax Quadrivalent in adults 18 years of age and older. Patients received Flucelvax Quadrivalent or one of the two formulations of comparator trivalent influenza vaccine (TIV1c or TIV2c). The immune response to each of the vaccine antigens was assessed 21 days after vaccination.

• The immunogenicity endpoints were geometric mean antibody titers (GMTs) of hemagglutination inhibition (HI) antibodies response and percentage of adults who achieved seroconversions, defined as a pre-vaccination HI titer of < 1:10 with a post-vaccination titer ≥ 1:40 or a prevaccination HI titer > 1:10 and at least 4-fold increase in serum HI antibody titer.

• Flucelvax Quadrivalent was noninferior to TIVc, which was assessed by ratios of GMTs and the differences in the percentages of adults achieving seroconversion at 3 weeks following vaccination. The antibody response to influenza B strains contained in Flucelvax Quadrivalent was superior to the antibody response after vaccination with TIVc containing an influenza B strain from the alternate lineage. 

Immunogenicity in Children and Adolescents 6 months through 17 years of age

Study 1

• The randomized, observer-blind, multicenter study evaluated the immunogenicity of Flucelvax Quadrivalent in children 6 months through 3 years of age. Patients received Flucelvax Quadrivalent or a US-licensed comparator quadrivalent influenza vaccine.

• The immunogenicity endpoints were geometric mean antibody titers (GMTs) and percentage of subjects who achieved seroconversion, defined as a pre-vaccination HI or microneutralization (MN) titer of < 1:10 with a post-vaccination titer ≥ 1:40 or with a pre-vaccination HI or MN titer ≥ 1:10 and a minimum 4-fold increase in serum antibody titer.

• Flucelvax Quadrivalent was noninferior to the comparator QIV, which was assessed by ratios of GMTs and the differences in the percentages of adults achieving seroconversion at 4 weeks following vaccination.

Study 5

• The randomized, double-blind, controlled study evaluated the immunogenicity of Flucelvax Quadrivalent in 1159 children 4 through 17 years of age. All patients received Flucelvax Quadrivalent.

• The immunogenicity endpoints were geometric mean antibody titers (GMTs) and percentage of subjects who achieved seroconversion, defined as a pre-vaccination HI or microneutralization (MN) titer of < 1:10 with a post-vaccination titer ≥ 1:40 or with a pre-vaccination HI or MN titer ≥ 1:10 and a minimum 4-fold increase in serum antibody titer.

• For all four influenza strains, the 95% LBCI seroconversion rates were ≥ 40% and the percentage of children and adolescents who achieved HI titer ≥ 1:40 post vaccination were ≥ 70% (95% LBCI).