AFLURIA QUADRIVALENT Rx

Efficacy Against Laboratory-Confirmed Influenza

• The efficacy of Afluria (trivalent formulation) is relevant to Afluria Quadrivalent. 

• The efficacy of Afluria (trivalent formulation) was based on the randomized, observer-blind, placebo-controlled Study 5 which included 15,044 participants 18 to 64 years of age. Participants were randomly assigned 2:1 to receive a single dose of Afluria (trivalent formulation) or placebo.

• Laboratory-confirmed influenza was assessed by active and passive surveillance of influenza-like illness (ILI) beginning 2 weeks post-vaccination until the end of the influenza season, approximately 6 months post-vaccination. ILI was defined as at least one respiratory symptom (e.g., cough, sore throat, nasal congestion) and at least one systemic symptom (e.g., oral temperature of 100.0ºF or higher, feverishness, chills, body aches). 

• Vaccine efficacy of Afluria against laboratory-confirmed influenza infection due to influenza A or B virus strains contained in the vaccine was 60% with a lower limit of the 95% CI of 41%.

• Vaccine efficacy of Afluria against laboratory-confirmed influenza infection due to any influenza virus strains was 42% with a lower limit of the 95% CI of 28%.

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 US in adults aged 18 years of age and older. Participants received 1 dose of either Afluria Quadrivalent (N=1691) or 1 of 2 formulations of comparator trivalent influenza vaccine (Afluria, trivalent) each containing an influenza type B virus.

• 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.

• Serum H1 antibody responses to Afluria Quadrivalent were noninferior to both trivalent (TIV) formulations  for all influenza strains for individuals 18 years of age and older. Noninferiority was also shown to both endpoints in both age subgroups, adults 18–64 years and 65 years and older, for all strains.

• Afluria Quadrivalent showed superior immune responses to each of the influenza B strains relative to the antibody response after TIV formulations not containing that B lineage strain for individuals 18 years of age and older. Afluria Quadrivalent was superior against the alternate B strain for each of the influenza B strains in both age subgroups.

Immunogenicity of Afluria (trivalent formulation) Administered by PharmaJet Stratis Needle-Free Injection System

• Study 2 was a randomized, comparator-controlled, non-inferiority study enrolled 1250 adults 18 through 64 years of age. The study evaluated the immune response following administration of Afluria (trivalent formulation) when delivered intramuscularly using either the PharmaJet Stratis Needle-Free Injection System or needle and syringe.

• The co-primary endpoints were HI GMT ratios for each vaccine strain and the absolute difference in seroconversion rates for each vaccine strain 28 days after vaccination.

• The PharmaJet Stratis Needle-Free Injection System demonstrated noninferiority to administration via needle and syringe. The PharmaJet Stratis Needle-Free Injection System also elicited higher immunological responses in younger patients (18 to 49 years) vs older patients (50 to 64 years).

Immunogenicity of Afluria Quadrivalent in Children 5 through 17 Years Administered by Needle and Syringe

• Study 3 was a randomized, observer-blinded, comparator-controlled trial conducted in the US in 2278 children 5 through 17 years of age. Patients were randomly assigned 3:1 to receive 1 or 2 doses of Afluria Quadrivalent or a US licensed comparator quadrivalent influenza vaccine. Patients 5 to 8 years of age were eligible to receive a second dose at least 28 days after the first dose depending on their influenza vaccination history.

• The co-primary endpoints were HI Geometric Mean Titer (GMT) ratios (adjusted for baseline HI titers and other covariates) and seroconversion rates for each vaccine strain, 28 days after the last vaccination.

• Serum HI antibody responses to Afluria Quadrivalent were noninferior for both GMT ratio and seroconversion rates relative to the comparator vaccine for all influenza strains.

Immunogenicity of Afluria Quadrivalent  in Children 6 Months through 59 Months Administered by Needle and Syringe

• Study 4 was a randomized, observer-blind, comparator-controlled trial conducted in the US in 2247 children 6 months through 59 months of age. Patients were randomly assigned 3:1 to receive Afluria Quadrivalent or a US-licensed comparator quadrivalent influenza vaccine.

• Children 6 months to 35 months received 1 or 2 doses (0.25mL each) and children 36 months to 59 months received 1 or 2 doses (0.5mL each). Patients were eligible to receive a second dose at least 28 days after the first dose based on their influenza vaccination history.

• The co-primary endpoints were HI GMT ratios for each vaccine strain and the absolute difference in seroconversion rates for each vaccine strain 28 days after vaccination.

• Serum HI antibody responses to Afluria Quadrivalent were noninferior for both GMT ratio and seroconversion rates relative to the comparator vaccine for all influenza strains.