TRANSFORM THE WAY YOU THINK ABOUT INFLUENZA PROTECTION

The 21st-century influenza vaccine for people 4 years and older.1

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FLUCELVAX QUADRIVALENT is made using cell culture technology1

FLUCELVAX QUADRIVALENT is the first and only cell culture-based quadrivalent influenza vaccine in the US that offers prevention against 4 influenza virus strains within the vaccines - virus subtypes A and type B contained in the vaccine - for people 4 years and older.1

Unlike many influenza vaccines that are made using chicken eggs, FLUCELVAX QUADRIVALENT is different - it's made using cell culture-based technology, one of the first major advances in influenza vaccine manufacturing since the 1930s. Plus, it's antibiotic free1,3,4

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Modern cell culture-based influenza vaccines

  • Use a readily available bank of frozen characterized cells5
  • Grow virus in closed sterile bioreactors6
  • Eliminate the need for antibiotics due to manufacturing technology1,6
  • Have the potential for rapid scale-up during outbreaks or pandemic5,7
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Egg-based influenza vaccines

  • Rely on egg availability, which may be affected by the avian influenza6,8
  • Grow virus in open systems8
  • May require use of antibiotics in manufacturing process9
  • May lack flexibility to respond quick5

You can help prevent the influenza with FLUCELVAX QUADRIVALENT.

6x

Is the distance people with influenza can spread it to others2

78%

before symptoms develop, people with influenza may be able to infect others2

45%

after becoming sick, healthy adults may still be able to infect others2

Order FLUCELVAX QUADRIVALENT today and check it off your to-do list.

Review FLUCELVAX QUADRIVALENT information here

FLUCELVAX QUADRIVALENT is the first and only cell culture-based quadrivalent influenza vaccine in the US that offers prevention against 4 influenza virus strains within the vaccine-virus subtypes A and type B contained in the vaccine-for people 4 years and older.1

Unlike many vaccines that are made using chicken eggs, FLUCELVAX QUADRIVALENT is different- it's made using cell culture-based technology, one of the first major advances in influenza vaccine manufacturing since the 1930s. Plus, it's antibiotic free.1,3,4

Proven influenza protection

Vaccine efficacy vs culture-confirmed influenza1,a

83.8%

of viruses matched to those in the vaccine

69.5%

of all influenza viruses

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.

FLUCELVAX QUADRIVALENT is an evolution of FLUCELVAX. Because they are made in the same way and have overlapping compositions, the clinical efficacy and safety of FLUCELVAX is relevant to FLUCELVAX QUADRIVALENT.1

Demonstrated immunogenicity in children and adults

Percentage of children and adolescents aged 4 through 17 years with seroconversiona-c postvaccination with FLUCELVAX QUADRIVALENT (Influenza Vaccine)1

Adolescent Seroconversion rates chart

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

HI GMTi ratios for TIV1c/TIV2cj to FLUCELVAX QUADRIVALENT in adults aged 18 years and older1,k,l

Adult Seroconversion rates chart

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.

Well tolerated in children and adultsa

Most common (≥10%) local and systemic adverse reactions observed within 7 days of vaccination with FLUCELVAX QUADRIVALENT1

Children 4 to <6 years of age

  • Injection site tenderness (46%)
  • Injection site erythema (18%)
  • Sleepiness (19%)
  • Irritability (16%)
  • Injection site induration (13%)
  • Change in eating habits (10%)

Children 6 to 8 years of age

  • Injection site pain (54%)
  • Injection site erythema (22%)
  • Injection site induration (16%)
  • Headache (14%)
  • Fatigue (13%)
  • Myalgia (12%)

Children and adolescents 9 through 17 years of age

  • Injection site pain (58%)
  • Headache (22%)
  • Injection site erythema (19%)
  • Fatigue (18%)
  • Myalgia (16%)
  • Injection site induration (15%)

Adults 18 to 64 years of age

  • Injection site pain (45.4%)
  • Headache (18.7%)
  • Fatigue (17.8%)
  • Myalgia (15.4%)
  • Injection site erythema (13.4%)
  • Injection site induration (11.6%)

Adults 65 years and older

  • Injection site pain (21.6%)
  • Injection site erythema (11.9%)

Incidence of serious adverse events (SAEs) reported within 6 months of vaccination1,b

Children and adolescents aged 4 to 17 years

0.5%

Adults 18 years and older

3.9%

Demonstrated Safety

Safety demonstrated in more than 11,000 subjects.1,8,a

In children who received a second dose of FLUCELVAX QUADRIVALENT (ie, children aged 4 to 8 years), the incidence of adverse events was similar to that seen with the first dose.1,b

a The safety of FLUCELVAX QUADRIVALENT was evaluated in 2 randomized, double-blind, controlled studies in which 5012 subjects (n=2332 children 4 through 17 years of age and 2680 adults 18 years and older) received FLUCELVAX QUADRIVALENT or 1 of 2 comparator trivalent vaccines (TIV1c or TIV2c). The safety populations included all subjects who provided postvaccination symptom data in the form of a symptom diary card for 7 days following vaccination.1

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  • For intramuscular injection only
  • Administer FLUCELVAX QUADRIVALENT as a 0.5-mL dose for people 4 and older
  • FLUCELVAX QUADRIVALENT is supplied in 2 product presentations; as a package of ten, 0.5-mL prefilled needleless syringes and as a 5-mL multidose vial
  • FLUCELVAX QUADRIVALENT multidose vial and prefilled syringe presentations are not made with natural rubber latex
  • The FLUCELVAX QUADRIVALENT prefilled syringe presentation is preservative free

Store FLUCELVAX QUADRIVALENT refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light. Do not freeze. Disregard if the vaccine has been frozen. Do not use after expiration date.

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