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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 Aged 6 through 35 months

In a clinical trial of subjects aged 6 through 35 months, FLULAVAL QUADRIVALENT 0.5-mL exhibited immunogenicity noninferior to the comparator, Fluzone Quadrivalent (Influenza Vaccine) 0.25-mL.1

  • Noninferiority based on adjusted geometric mean titers (GMTs) and seroconversion rates1

Noninferiority of FLULAVAL QUADRIVALENT Relative to Comparator Quadrivalent Influenza Vaccine at 28 Days Post-vaccination in Children Aged 6 Through 35 Months (According-to-Protocol Cohort for Immunogenicity)1,*,†,

Adjusted GMTs Against Strain

Seroconversion to:

CI=Confidence interval.

* Trial 4: NCT02242643.
According-to-protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available after vaccination for at least one trial vaccine antigen.

Noninferior to the comparator vaccine based on adjusted GMTs (upper limit of the 2-sided 95% CI for the GMT ratio [comparator/FLULAVAL QUADRIVALENT] ≤1.5) and seroconversion rates (upper limit of the 2-sided 95% CI on difference of comparator vaccine minus FLULAVAL QUADRIVALENT ≤10%).

§ A 0.5-mL dose containing 15 mcg each of A/California/07/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/02/2012 (Yamagata lineage), and B/Brisbane/60/2008 (Victoria lineage).

|| A 0.25-mL dose of US-licensed quadrivalent, inactivated influenza vaccine (manufactured by Sanofi Pasteur Inc.) containing A/California/07/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/02/2012 (Yamagata lineage), and B/Brisbane/60/2008 (Victoria lineage).

Seroconversion defined as a 4-fold increase in post-vaccination antibody titer from pre-vaccination titer ≥1:10, or an increase in titer from <1:10 to ≥1:40.

Study Design

FLULAVAL QUADRIVALENT was studied in a randomized, observer-blind, active-controlled immunogenicity and safety trial. The trial included subjects aged 6 through 35 months who received FLULAVAL QUADRIVALENT 0.5‑mL (n=1,207) or Fluzone Quadrivalent 0.25‑mL (n=1,217). Immune responses were evaluated in sera obtained 28 days following 1 or 2 doses of FLULAVAL QUADRIVALENT or the comparator.1

Children aged 3 through 17 years

FLULAVAL QUADRIVALENT exhibited immunogenicity noninferior to two trivalent inactivated influenza vaccines in a clinical trial.1

  • Noninferiority was based on adjusted GMTs and seroconversion rates1
  • Seroconversion was defined as at least a 4-fold increase in serum HI titer over baseline to ≥1:401
Study Design

FLULAVAL QUADRIVALENT was studied in a randomized, double-blind, active-controlled trial. Subjects aged 3 through 17 years received FLULAVAL QUADRIVALENT or 1 of 2 formulations of a comparator trivalent influenza vaccine. Immune responses were evaluated in sera obtained 28 days following 1 or 2 doses of FLULAVAL QUADRIVALENT or the comparators.1

Adults aged 18 years and older

FLULAVAL QUADRIVALENT exhibited immunogenicity noninferior to two trivalent inactivated influenza vaccines in a clinical trial.1

  • Noninferiority based on adjusted GMTs1
Study Design

FLULAVAL QUADRIVALENT was studied in a randomized, double-blind, active-controlled immunogenicity and safety trial. Subjects aged 18 years and older received FLULAVAL QUADRIVALENT or 1 of 2 formulations of a comparator trivalent influenza vaccine. Immune responses were evaluated in sera obtained 21 days after administration of FLULAVAL QUADRIVALENT or the comparators.1

FLULAVAL is a registered trademark of the GSK group of companies.

References:

  1. Prescribing Information for FLULAVAL 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. Accessed November 14, 2018.
  3. American Medical Association. CPT® 2019 Professional Edition. Chicago, IL: AMA Press; 2018.
  4. Prescribing Information for Fluzone Quadrivalent.
  5. Hibbs BF, Moro PL, Lewis P, et al. Vaccination errors reported to the Vaccine Adverse Event Reporting System, (VAERS) United States, 2000-2013. Vaccine. 2015;33(28):3171-3178.
  6. Institute for Safe Medication Practices. Frequently reported vaccine errors to ISMP VERP. Pharm Today. 2016;22(1):72.
  7. Influenza: about flu. Centers for Disease Control and Prevention website. https://www.cdc.gov/flu/about/index.html. Updated October 26, 2018. Accessed November 14, 2018.
  8. Estimated Influenza Illnesses, Medical Visits, and Hospitalizations Averted by Vaccination in the United States. Centers for Disease Control and Prevention website. https://www.cdc.gov/flu/about/disease/2016-17.htm. Updated May 22, 2016. Accessed November 14, 2018.
  9. Flu vaccination coverage, United States, 2016-17 influenza season. Centers for Disease Control and Prevention website. https://www.cdc.gov/flu/fluvaxview/coverage-1617estimates.htm. Updated September 28, 2017. Accessed November 14, 2018.
  10. People 65 years and older & influenza. Centers for Disease Control and Prevention website. https://www.cdc.gov/flu/about/disease/65over.htm. Updated September 4, 2018. Accessed November 14, 2018.
  11. People at high risk of developing serious flu-related complications. Centers for Disease Control and Prevention website. https://www.cdc.gov/flu/about/disease/high_risk.htm. Updated August 27, 2018. Accessed November 14, 2018.

INDICATION

FLULAVAL 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. FLULAVAL QUADRIVALENT is approved for use in persons aged 6 months and older.

Important Safety Information for FLULAVAL QUADRIVALENT

  • Do not administer FLULAVAL 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 FLULAVAL 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 FLULAVAL QUADRIVALENT. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
  • If FLULAVAL 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 FLULAVAL QUADRIVALENT in adults, the most common solicited local adverse reaction was pain and the most common solicited systemic adverse reactions were muscle aches, headache, fatigue, and arthralgia. In children 6 through 35 months of age, the most common solicited local adverse reaction was pain and the most common solicited systemic adverse reactions were irritability, drowsiness, and loss of appetite. In children 3 through 17 years of age, the most common solicited local adverse reaction was pain. In children 3 through 4 years of age, the most common solicited systemic adverse reactions were irritability, drowsiness, and loss of appetite. In children 5 through 17 years of age, the most common solicited systemic adverse reactions were muscle aches, fatigue, headache, arthralgia, and gastrointestinal symptoms. (See Adverse Reactions section of the Prescribing Information for FLULAVAL QUADRIVALENT for other potential adverse reactions and events)
  • Vaccination with FLULAVAL QUADRIVALENT may not result in protection in all vaccine recipients

Please see full Prescribing Information for FLULAVAL QUADRIVALENT.

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