Seroconversion rates at day 22b
Data reflect results from a pivotal trial that evaluated the safety and immunogenicity of FLUAD in comparison to AGRIFLU®. A total of 7082 subjects were randomized and vaccinated with FLUAD (N=3541) or AGRIFLU (N=3541).
CI=confidence interval; GMT=geometric mean antibody titer; HI=hemagglutinin inhibition; N=the number of vaccinated participants with available data from the immunologic endpoint listed.
aAGRIFLU. bFLUAD met non-inferiority criteria based on seroconversion rate differences if the lower limit of the 95% CI [FLUAD–AGRIFLU] for each strain was ≥10%. cFLUAD met non-inferiority criteria based on GMT ratios if the lower limit of the 95% CI [FLUAD–AGRIFLU] for each strain was >0.67.
GMT and GMT ratios at day 22c
Data reflect results from a pivotal trial that evaluated the safety and immunogenicity of FLUAD in comparison to AGRIFLU®. A total of 7082 subjects were randomized and vaccinated with FLUAD (N=3541) or AGRIFLU (N=3541).
CI=confidence interval; GMT=geometric mean antibody titer; HI=hemagglutinin inhibition; N=the number of vaccinated participants with available data from the immunologic endpoint listed.
aAGRIFLU. bFLUAD met non-inferiority criteria based on seroconversion rate differences if the lower limit of the 95% CI [FLUAD–AGRIFLU] for each strain was ≥10%. cFLUAD met non-inferiority criteria based on GMT ratios if the lower limit of the 95% CI [FLUAD–AGRIFLU] for each strain was >0.67.
QUADRIVALENT FORMULATION

ROBUST IMMUNE RESPONSE IN 4 STRAINS

FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted) uses the same adjuvant technology with 4 strains.2
Seroconversion rates at day 21a
Data reflect results from a randomized, observer-blind, non-influenza comparator-controlled, multicenter efficacy study that evaluated the immunogenicity of FLUAD QUADRIVALENT. Adult subjects 65 years of age and older received 1 dose of either FLUAD QUADRIVALENT (N=3379) or a US-licensed non-influenza comparator vaccine (N=3382).c
aSuccess criterion: lower bound of the 95% CI for the seroconversion rate must be ≥30%. bSuccess criterion: lower bound of the 95% CI for the % of subjects with HI titer ≥1:40 must be ≥60%. cNon-influenza comparator vaccine=combined tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine, Boostrix® (GlaxoSmithKline Biologicals).
Proportion of subjects with HI titer ≥1:40 at day 21b
Data reflect results from a randomized, observer-blind, non-influenza comparator-controlled, multicenter efficacy study that evaluated the immunogenicity of FLUAD QUADRIVALENT. Adult subjects 65 years of age and older received 1 dose of either FLUAD QUADRIVALENT (N=3379) or a US-licensed non-influenza comparator vaccine (N=3382).c
aSuccess criterion: lower bound of the 95% CI for the seroconversion rate must be ≥30%. bSuccess criterion: lower bound of the 95% CI for the % of subjects with HI titer ≥1:40 must be ≥60%. cNon-influenza comparator vaccine=combined tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine, Boostrix® (GlaxoSmithKline Biologicals).
TRIVALENT AND QUADRIVALENT FORMULATION

DEMONSTRATED SAFETY PROFILE

FLUAD and FLUAD QUADRIVALENT safety profile established in randomized clinical trials.1,2
FLUAD has a similar safety profile to that of a non-adjuvanted, standard-dose influenza vaccine.
Most common (≥10%) local and systemic adverse reactions observed within 7 days of vaccination with FLUAD or non-adjuvanted, standard-dose influenza vaccine.1
While more frequent injection-site-related events were reported for FLUAD, most were mild to moderate.1
N=the number of subjects with safety data.
aModerate: pain, tenderness, myalgia, fatigue, headache, arthralgia, chills, nausea, vomiting defined as “some limitation in normal daily activity,” diarrhea defined as “4 to 5 stools a day.” bSevere: pain, tenderness, myalgia, fatigue, headache, arthralgia, chills, nausea, vomiting defined as “unable to perform normal daily activity,” diarrhea defined as “6 or more watery stools a day.” cPotentially life-threatening (PLT) reaction defined as requiring emergency room visit or hospitalization.
The safety of FLUAD QUADRIVALENT was evaluated in 2 multicenter, randomized controlled trials in 4269 adults 65 years and older.2
In Study 1, most common (≥10%) local and systemic adverse reactions observed within 7 days of vaccination with FLUAD QUADRIVALENT or a non-influenza comparator vaccine.2
N=the number of subjects with safety data.
aSolicited safety population: all subjects in the exposed population who received a study vaccine and provided postvaccination solicited safety data. bSevere reactions of each type were reported in 1.1% or fewer subjects receiving FLUAD QUADRIVALENT; severe reactions of each type were also reported in the comparator group at similar percentages. Severe definitions: erythema, induration, and ecchymosis=>100 mm diameter; injection-site pain, nausea, fatigue, myalgia, arthralgia, headache, and chills=prevents daily activity; loss of appetite=not eating at all; vomiting=6 or more times in 24 hours or requires intravenous hydration; diarrhea=6 or more loose stools in 24 hours or requires intravenous hydration; fever=≥102.2 °F (39 °C).
In Study 2, FLUAD QUADRIVALENT demonstrated a similar safety profile to that of FLUAD.2
Solicited local and systemic adverse reactions reported were similar to those reported for Study 1.
270+ MILLION DOSES DISTRIBUTED WORLDWIDE3
*Doses distributed globally as of July 2023 and includes both FLUAD and FLUAD QUADRIVALENT.
Choose FLUAD QUADRIVALENT for your eligible patients 65+ years2
  • Covered by Medicare Part B and by most Medicare Advantage Plans with no copay*
  • CPT reimbursement code
    • Single-dose syringe: 90694
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*This information does not constitute a guarantee or warranty of coverage benefits or reimbursement.

INDICATION AND IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Do not administer FLUAD QUADRIVALENT or AFLURIA QUADRIVALENT to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine, including egg protein, or to a previous influenza vaccine.

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

WARNINGS AND PRECAUTIONS

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

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

Syncope (fainting) may occur in association with administration of injectable vaccines. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Ensure procedures are in place to avoid falling injury and to restore cerebral perfusion following syncope by maintaining a supine or Trendelenburg position.

The immune response to FLUAD QUADRIVALENT, FLUCELVAX QUADRIVALENT, or AFLURIA QUADRIVALENT in immunocompromised persons, including individuals receiving immunosuppressive therapy, may be lower than in immunocompetent individuals.

Vaccination with FLUAD QUADRIVALENT, FLUCELVAX QUADRIVALENT, or AFLURIA QUADRIVALENT may not protect all vaccine recipients against influenza disease.

ADVERSE REACTIONS

FLUAD QUADRIVALENT:

The most common (≥ 10%) local and systemic reactions with FLUAD QUADRIVALENT in elderly subjects 65 years of age and older were injection site pain (16.3%), headache (10.8%) and fatigue (10.5%). Other adverse events may occur.

FLUCELVAX QUADRIVALENT:

In children 6 months through 3 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were tenderness (27.9%), erythema (25.8%), induration (17.3%) and ecchymosis (10.7%). The most common systemic adverse reactions were irritability (27.9%), sleepiness (26.9%), diarrhea (17.9%) and change of eating habits (17.4%).

In children 2 through 8 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were tenderness (28.7%), pain (27.9%) and erythema (21.3%), induration (14.9%) and ecchymosis (10.0%). The most common systemic adverse reactions were sleepiness (14.9%), headache (13.8%), fatigue (13.8%), irritability (13.8%) and loss of appetite (10.6%).

In children and adolescents 9 through 17 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were injection site pain (21.7%), erythema (17.2%) and induration (10.5%). The most common systemic adverse reactions were headache (18.1%) and fatigue (17.0%).

In adults 18 through 64 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were pain (45.4%), erythema (13.4%) and induration (11.6%). The most common systemic adverse reactions were headache (18.7%), fatigue (17.8%) and myalgia (15.4%).

In adults ≥65 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were pain (21.6%) and erythema (11.9%).

Other adverse events may occur.

AFLURIA QUADRIVALENT:

AFLURIA QUADRIVALENT administered by needle and syringe:

In children 6 months through 35 months of age, the most frequently reported injection site reactions in the clinical study with AFLURIA QUADRIVALENT administered by needle and syringe were pain and redness (≥ 20%). The most common systemic adverse events were irritability (≥ 30%), diarrhea and loss of appetite (≥ 20%).

In children 36 through 59 months of age, the most commonly reported injection site reactions in the clinical study with AFLURIA QUADRIVALENT administered by needle and syringe were pain (≥ 30%) and redness (≥ 20%). The most commonly reported systemic adverse events were malaise and fatigue, and diarrhea (≥ 10%).

In children 5 through 8 years, the most commonly reported injection-site adverse reactions when AFLURIA QUADRIVALENT was administered by needle and syringe were pain (≥ 50%), redness and swelling (≥ 10%). The most common systemic adverse event was headache (≥ 10%).

In children 9 through 17 years, the most commonly reported injection-site adverse reactions when AFLURIA QUADRIVALENT was administered by needle and syringe were pain (≥ 50%), redness and swelling (≥ 10%). The most common systemic adverse events were headache, myalgia, and malaise and fatigue (≥ 10%).

In adults 18 through 64 years of age, the most commonly reported injection-site adverse reaction observed in clinical studies with AFLURIA QUADRIVALENT administered by needle and syringe was pain (≥ 40%). The most common systemic adverse events observed were myalgia and headache (≥ 20%).

In adults 65 years of age and older, the most commonly reported injection-site adverse reaction observed in clinical studies with AFLURIA QUADRIVALENT administered by needle and syringe was pain (≥ 20%). The most common systemic adverse event observed was myalgia (≥ 10%).

AFLURIA (trivalent formulation) administered by PharmaJet Stratis Needle-Free Injection System:

The safety experience with AFLURIA (trivalent formulation) is relevant to AFLURIA QUADRIVALENT because both vaccines are manufactured using the same process and have overlapping compositions.

In adults 18 through 64 years of age, the most commonly reported injection-site adverse reactions observed in a clinical study with AFLURIA (trivalent formulation) using the PharmaJet Stratis Needle-Free Injection System were tenderness (≥ 80%), swelling, pain, redness (≥ 60%), itching (≥ 20%) and bruising (≥ 10%). The most common systemic adverse events were myalgia, malaise (≥ 30%) and headache (≥ 20%).

Other adverse events may occur.

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

Before administration, please see the full US Prescribing Information for FLUAD QUADRIVALENT, FLUCELVAX QUADRIVALENT and AFLURIA QUADRIVALENT.

FLUAD® QUADRIVALENT, FLUCELVAX® QUADRIVALENT, AFLURIA® and AFLURIA® QUADRIVALENT are registered trademarks of Seqirus UK Limited or its affiliates.

PharmaJet® and STRATIS® are registered trademarks of PharmaJet.

References : 1. FLUAD. Package insert. Seqirus Inc 2. FLUAD QUADRIVALENT. Package insert. Seqirus Inc 3. Data on file. Seqirus Inc; 2023.