FLUCELVAX QUADRIVALENT®

Building on a foundation of influenza protection

FLUCELVAX QUADRIVALENT is the next evolution of FLUCELVAX (Influenza Vaccine)

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

FLUCELVAX has been shown to be efficacious against influenza caused by1:

  • Vaccine-like strains (83.8%)

  • All circulating influenza strains (69.5%)

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Efficacy of FLUCELVAX against culture-confirmed influenza1,a,b

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of viruses matched to those in the vaccine

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of all influenza viruses

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a Efficacy is defined as a reduction in the percentage of people with laboratory-confirmed influenza in a vaccinated group compared with the rate of infections in an unvaccinated group.2 Influenza diagnosis is typically confirmed via isolation of the influenza virus in culture or from reverse-transcriptase polymerase chain reaction.3 b Clinical efficacy was assessed in a multinational, randomized, observer-blind, placebo-controlled trial involving 11,404 adults aged 18 through 49 years.1

References: 1. FLUCELVAX QUADRIVALENT [package insert]. Holly Springs, NC: Seqirus Inc; 2016. 2. Flu vaccine effectiveness: questions and answers for health professionals. Centers for Disease Control and Prevention website. http://www.cdc.gov/flu/professionals/vaccination/effectivenessqa.htm. Updated 2013. Accessed November 30, 2015. 3. Influenza signs and symptoms and the role of laboratory diagnostics. Centers for Disease Control and Prevention website. http://www.cdc.gov/flu/professionals/diagnosis/labrolesprocedures.htmlabrolesprocedures.htm. Updated 2015. Accessed December 1, 2015.

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FLUCELVAX® QUADRIVALENT IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE FOR FLUCELVAX QUADRIVALENT® (INFLUENZA VACCINE)

FLUCELVAX QUADRIVALENT is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FLUCELVAX QUADRIVALENT is approved for use in persons
4 years of age and older.

FLUCELVAX® QUADRIVALENT IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE FOR FLUCELVAX QUADRIVALENT® (INFLUENZA VACCINE)

FLUCELVAX QUADRIVALENT is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FLUCELVAX QUADRIVALENT is approved for use in persons 4 years of age and older.

CONTRAINDICATIONS

  • • Do not administer FLUCELVAX QUADRIVALENT to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine.

WARNINGS & PRECAUTIONS

  • Guillain-Barré Syndrome (GBS): If GBS has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUCELVAX QUADRIVALENT should be based on careful consideration of the potential benefits and risks.

ADVERSE REACTIONS

  • The most common (≥10%) local and systemic reactions in adults 18-64 years of age were injection site pain (45.4%),
    headache (18.7%), fatigue (17.8%), myalgia (15.4%), injection site erythema (13.4%), and induration (11.6%).
  • The most common (≥10%) local and systemic reactions in adults ≥65 years of age were injection site pain (21.6%) and injection site erythema (11.9%).
  • The most common (≥10%) local and systemic reactions in children 4 to <6 years of age were tenderness at the injection site (46%), injection site erythema (18%), sleepiness (19%), irritability (16%), injection site induration (13%), and change in eating habits (10%).
  • The most common (≥10%) local and systemic reactions in children 6 through 8 years of age were pain at the injection site (54%), injection site erythema (22%), injection site induration (16%), headache (14%), fatigue (13%), and myalgia (12%).
  • The most common (≥10%) local and systemic reactions in children and adolescents 9 through 17 years of age were pain at the injection site (58%), headache (22%), injection site erythema (19%), fatigue (18%), myalgia (16%), and injection site induration (15%).

To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov.

Please see accompanying US full Prescribing Information for FLUCELVAX QUADRIVALENT.

FLUCELVAX QUADRIVALENT is a registered trademark of Seqirus UK Limited or its affiliates