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IMMUNOGENICITY

In clinical trials, FLULAVAL QUADRIVALENT 0.5-mL exhibited immunogenicity noninferior to both quadrivalent and trivalent flu vaccine comparators across a broad age range of patients.1

Children 6 through 35 months

  • Immunogenicity was evaluated in comparison to non-influenza active comparator vaccines in a clinical trial1
    - Immunogenicity was based on geometric mean titers and seroconversion rates (defined as the percentage of vaccinees with a pre-vaccination hemagglutination-inhibition [HI] titer of <1:10 with a post-vaccination titer ≥1:40 or at least a 4-fold increase in serum titers of HI antibodies to ≥1:40)

Geometric Mean Titers (GMTs)1

Seroconversion Rates1

Study Design: FLUARIX QUADRIVALENT was studied in a randomized, observer-blind, non-influenza vaccine-controlled efficacy, immunogenicity, and safety trial. The trial included subjects aged 6 through 35 months who received 1 or 2 doses of FLUARIX QUADRIVALENT 0.5 mL (n=6,006) or a non-influenza control vaccine (n=6,012). Immune responses were evaluated in sera obtained 28 days following 1 or 2 doses of FLUARIX QUADRIVALENT or the comparator in a subgroup of subjects (n=753 for FLUARIX QUADRIVALENT, n=579 for control).1

Children 3 through 17 years

FLUARIX QUADRIVALENT exhibited immunogenicity non-inferior to two trivalent inactivated influenza vaccines in a clinical trial.1

  • Non-inferiority was based on adjusted geometric mean titers and seroconversion rates1
  • Seroconversion was defined as a pre-vaccination hemagglutination-inhibition (HI) titer of <1:10 with a post-vaccination titer ≥1:40 or at least a 4-fold increase in serum HI titer over baseline to ≥1:401

Study Design: FLUARIX QUADRIVALENT was studied in a randomized, double-blind, active-controlled, non-inferiority, immunogenicity, and safety trial. Subjects aged 3 through 17 years received 1 or 2 doses of FLUARIX QUADRIVALENT (n=915) or 1 of 2 formulations of a comparator trivalent influenza vaccine (FLUARIX, TIV-1, n=912 or TIV-2, n=911), each containing an influenza type B virus that corresponded to one of the 2 type B viruses in FLUARIX QUADRIVALENT. Immune responses were evaluated in sera obtained 28 days following 1 or 2 doses of FLUARIX QUADRIVALENT or the comparators in the According-to-Protocol cohort (n=791 for FLUARIX QUADRIVALENT, n=819 for FLUARIX, TIV-1, and n=801 for TIV-2).1

Adults

FLUARIX QUADRIVALENT exhibited immunogenicity non-inferior to two trivalent inactivated influenza vaccines in a clinical trial.1

  • Non-inferiority based on adjusted GMTs and seroconversion rates1
  • Seroconversion was defined as a pre-vaccination hemagglutination-inhibition (HI) titer of <1:10 with a post-vaccination titer ≥1:40 or at least a 4-fold increase in serum HI titer over baseline to ≥1:401

Study Design: FLUARIX QUADRIVALENT was studied in a randomized, double-blind (2 arms), open-label (1 arm), active-controlled, immunogenicity, safety, and non-inferiority trial. Subjects aged 18 years and older received FLUARIX QUADRIVALENT (n=3,036) or 1 of 2 formulations of a comparator trivalent influenza vaccine (FLUARIX, TIV-1, n=1,010 or TIV-2, n=610). Immune responses were evaluated in sera obtained 21 days after administration of FLUARIX QUADRIVALENT or the comparators in the According-to-Protocol cohort (n=1,809 for FLUARIX QUADRIVALENT, n=608 for FLUARIX, TIV-1, and n=534 for TIV-2).

References:

  1. Prescribing Information for FLUARIX QUADRIVALENT.
  2. Grohskopf LA, Sokolow LZ, Broder KR, et al. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices—United States, 2018-19 influenza season. MMWR. 2018;67(3):1-20. https://www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6703a1-H.pdf. Published August 24, 2018. February 6, 2019.
  3. American Medical Association. Current Procedural Terminology 2018: Standard Edition. Abraham M, Ahlman JT, Boudreau AJ, et al, eds. Chicago, IL: AMA Press; 2019.
  4. Hibbs BF, Moro PL, Lewis P, Miller ER, Shimabukuro TT. Vaccination errors reported to the Vaccine Adverse Event Reporting System, (VAERS) United States, 2000-2013. Vaccine. 2015;33(28):3171-3178.
  5. Institute for Safe Medication Practices. Frequently reported vaccine errors to ISMP VERP. Pharm Today. 2016;22(1):72. https://www.pharmacytoday.org/article/S1042-0991(15)00033-X/fulltext. February 6, 2019.
  6. Centers for Disease Control and Prevention. Influenza: about flu. https://www.cdc.gov/flu/about/index.html. Reviewed September 5, 2019. Accessed November 18, 2019.
  7. Centers for Disease Control and Prevention. Estimated influenza illnesses, medical visits, hospitalizations, and deaths in the United States - 2017-2018 influenza season. https://www.cdc.gov/flu/about/burden/2017-2018.htm. Accessed February 6, 2019.
  8. Centers for Disease Control and Prevention. Estimates of flu vaccination coverage among children - United States, 2017-18 flu season. https://www.cdc.gov/flu/fluvaxview/coverage-1718estimates-children.htm. Accessed February 6, 2019.
  9. Centers for Disease Control and Prevention. People 65 years and older & influenza. https://www.cdc.gov/flu/about/disease/65over.htm. Updated September 4, 2018. Accessed February 6, 2019.
  10. Centers for Disease Control and Prevention. People at high risk of developing serious flu-related complications. https://www.cdc.gov/flu/about/disease/high_risk.htm. Updated August 27, 2018. Accessed February 6, 2019.

INDICATION

FLUARIX QUADRIVALENT is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FLUARIX QUADRIVALENT is approved for use in persons aged 6 months and older.

Important Safety Information for FLUARIX QUADRIVALENT

  • Do not administer FLUARIX QUADRIVALENT to anyone with a history of severe allergic reactions (eg, anaphylaxis) to any component of the vaccine, including egg protein, or following a previous dose of any influenza vaccine
  • If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUARIX QUADRIVALENT should be based on careful consideration of the potential benefits and risks
  • Syncope (fainting) can occur in association with administration of injectable vaccines, including FLUARIX QUADRIVALENT. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
  • If FLUARIX QUADRIVALENT is administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the immune response may be lower than in immunocompetent persons
  • In clinical trials with FLUARIX QUADRIVALENT in adults, the most common solicited local adverse reaction was pain and the most common systemic adverse reactions were muscle aches, headache, and fatigue. In children 6 through 35 months of age, the most common solicited local adverse reactions were pain and redness and the most common systemic adverse reactions were irritability, loss of appetite, and drowsiness. In children 3 through 17 years of age, the solicited local adverse reactions were pain, redness, and swelling. In children 3 through 5 years of age, the most common systemic adverse reactions were drowsiness, irritability, and loss of appetite. In children 6 through 17 years of age, the most common systemic adverse reactions were fatigue, muscle aches, headache, arthralgia, and gastrointestinal symptoms. (See Adverse Reactions section of the Prescribing Information for FLUARIX QUADRIVALENT for other potential adverse reactions and events)
  • Vaccination with FLUARIX QUADRIVALENT may not result in protection in all vaccine recipients

Please see full Prescribing Information for FLUARIX QUADRIVALENT.

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