FLUZONE QUADRIVALENT Rx

The efficacy of Fluzone Quadrivalent was based on the efficacy data for Fluzone (trivalent influenza vaccine) and on an evaluation of serum HI antibody response to Fluzone Quadrivalent.

Efficacy of Fluzone (Trivalent Influenza Vaccine) in Children 6 through 24 Months of Age

• The randomized, double-blind, placebo-controlled study evaluated the efficacy of Fluzone Quadrivalent in 786 children 6 through 24 months of age at a single US center during the 1999-2000 (Year 1) and 2000-2001 (Year 2) influenza seasons. Patients were randomly assigned 2:1 to receive two 0.25mL doses of either Fluzone or a placebo.

• Estimated efficacy against culture-confirmed influenza in the intent-to-analysis set for Fluzone vs placebo:

• Year 1 (1999-2000) – Relative Risk, 0.34 (95% CI, 0.18-0.64); Percent Relative Reduction, 66% (95% CI, 36-82)

• Year 2 (2000-2001) – Relative Risk, 1.10 (95% CI, 0.34-3.50); Percent Relative Reduction, -10% (95% CI, -250, 66)

Efficacy of Fluzone (Trivalent Influenza Vaccine) in Adults

• The randomized, double-blind, placebo-controlled study evaluated the efficacy of Fluzone Quadrivalent in healthy adults at a single US center during the 2007-2008 influenza season. Patients were randomly assigned to receive 1 dose of either Fluzone, an active comparator, or placebo. The intent-to-treat analysis set included 1138 healthy adults who received Fluzone or placebo.

• Estimated efficacy against culture-confirmed influenza in the intent-to-analysis set for Fluzone vs placebo:

• Positive culture – Relative Risk, 0.27 (95% CI, 0.16-0.46); Percent Relative Reduction, 73% (95% CI, 54-84)

• Positive PCR – Relative Risk, 0.32 (95% CI, 0.20-0.52); Percent Relative Reduction, 68% (95% CI, 48-80)

• Positive culture, Positive PCR, or both – Relative Risk, 0.32 (95% CI, 0.20-0.52); Percent Relative Reduction, 68% (95% CI, 48-80)

Immunogenicity of Fluzone Quadrivalent in Children 6 Months through 8 Years of Age

• Study 1 included 1419 children 6 months through 35 months of age and 2101 children 3 years through 8 years of age in the per-protocol immunogenicity analysis. Patients 6 months through 35 months of age received one or two 0.25mL doses, and patients 3 years through 8 years of age received one or two 0.5mL doses of Fluzone Quadrivalent, TIV-1, or TIV-2. For patients who received two doses, the doses were given by 4 weeks apart.

• Non-inferiority immunogenicity criteria based on HI antibody GMTs and seroconversion rates were also met when age subgroups (6 months to <36 months and 3 years to <9 years) were examined. Fluzone Quadrivalent had higher HI antibody GMTs and seroconversion rates vs TIV for the B strain not contained in each respective TIV.

Immunogenicity of the 0.5 mL Dose of Fluzone Quadrivalent in Children 6 Months through 35 Months of Age 

• Study 2 included 1027 children 6 months through 35 months of age in the per-protocol immunogenicity analysis. Patients received one or two doses of either 0.25mL or 0.5mL of Fluzone Quadrivalent.

• Fluzone Quadrivalent achieved noninferiority of the 0.5mL dose(s) relative to the 0.25mL dose(s) for all strains. The GMT ratios for A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage strains were 1.42 (95% CI, 1.16-1.74), 1.48 (95% CI, 1.21-1.82), 1.33 (95% CI, 1.09-1.62), and 1.41 (95% CI, 1.17-1.70), respectively.

• Fluzone Quadrivalent also had seroconversion rate differences for the A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage strains of 4.6% (95% CI, -0.4%, 9.6%), 5.1% (95% CI, 0.4%, 9.8%), 1.3% (95% CI, -2.9%, 5.6%), and 2.6% (95% CI, -1.4%, 6.5%), respectively.

Immunogenicity of Fluzone Quadrivalent in Adults ≥18 Years of Age

• Study 3 included 565 adults 18 years of age and older who received one dose of Fluzone Quadrivalent, TIV-1, or TIV-2 in the per-protocol immunogenicity analysis.

• Fluzone Quadrivalent achieved noninferiority for HI antibody GMTs 21 days after vaccination compared to each TIV for all 4 strains. The GMT ratios for Fluzone Quadrivalent vs Pooled TIV for A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage strains were 1.06 (95% CI, 0.87-1.31), 0.90 (95% CI, 0.70-1.15), 0.89 (95% CI, 0.70-1.12), and 1.15 (95% CI, 0.93-1.42), respectively.

Immunogenicity of Fluzone Quadrivalent in Geriatric Adults ≥65 Years of Age

• Study 4 included 660 adults 65 years of age and older in the per-protocol immunogenicity analysis.

• Fluzone Quadrivalent achieved noninferiority for HI antibody GMTs 21 days after vaccination compared to those following TIV for all 4 strains. 

• Fluzone Quadrivalent achieved noninferiority for seroconversion rates 21 days after vaccination to those following TIV for H3N2, B/Brisbane, and B/Florida, but not for H1N1. The HI antibody GMT following Fluzone Quadrivalent was higher than that following TIV-1 for B/Florida but not higher than that following TIV-2 for B/Brisbane. Seroconversion rates following Fluzone Quadrivalent were higher than those following TIV for the B strain not contained in each respective TIV.