Choose an influenza vaccine that is preferentially recommended by ACIP1
FLUAD® QUADRIVALENT is the first-and-only adjuvanted quadrivalent seasonal influenza vaccine1
APPROVED FOR PATIENTS65+ YEARS2
229 million doses distributed over 20+ years*3
Order Today*Doses distributed globally as of June 2022 and includes both FLUAD and FLUAD QUADRIVALENT.
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The adjuvant difference
Key Features2- Made with MF59® Adjuvant
- Preservative free
- For intramuscular injection
- 0.5-mL pre-filled syringe
- 10 syringes per carton
- Syringe, plunger, and tip cap are not made from natural rubber latex
FLUAD QUADRIVALENT with MF59® Adjuvant produces robust immune responses.
Compared to FLUAD, FLUAD QUADRIVALENT includes an additional B strain to help prevent disease caused by all 4 influenza strains represented in the vaccine.2
For the non-influenza comparator vaccine, the proportion of subjects with HI titers greater than or equal to 1:40 at Day 21 were 46.7% for the A/H1N1 strain, 41.7% for A/H3N2, 21.5% for B/Yamagata, and 18.4% for B/Victoria. The seroconversion rates for the non-influenza comparator vaccine were 2.1% for A/H1N1, 3.9% for A/H3N2, 3.6% for B/Yamagata, and 2.1% for B/Victoria.
Study 1 evaluated the immunogenicity of FLUAD QUADRIVALENT in a randomized, observer-blind, non-influenza comparator-controlled, multicenter efficacy study. 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).
aSuccess criterion: lower bound of the 95% CI for the % of subjects with HI titer ≥1:40 must be ≥60%bSeroconversion is defined as a prevaccination HI titer <1:10 and postvaccination HI titer ≥1:40 or at least a 4-fold increase in HI from prevaccination HI titer ≥1:10. Success criterion: lower bound of the 95% CI for the seroconversion rate must be ≥30%.cNon-influenza comparator vaccine=combined tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine, Boostrix® (GlaxoSmithKline Biologicals)
The safety of FLUAD QUADRIVALENT was evaluated in 2 multicenter, randomized controlled trials in 4269 adults 65 years and older.1
In Study 1, most common (≥10%) local and systemic adverse reactions were observed within 7 days of vaccination with FLUAD QUADRIVALENT or a non-influenza comparator vaccine.1
N=number of subjects with solicited 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.1
Solicited local and systemic adverse reactions reported were similar to those reported for Study 1.
For intramuscular injection only.1
FLUAD QUADRIVALENT is supplied as a package of ten 0.5-mL prefilled needleless syringes.1
Administer FLUAD QUADRIVALENT as a single 0.5-mL intramuscular injection in adults 65 years of age and older.1
Each 0.5-mL dose of FLUAD QUADRIVALENT does not contain a preservative. The syringe, plunger, and tip cap are not made with natural rubber latex.1
Store FLUAD QUADRIVALENT at 2°C to 8°C (36°F to 46°F). Protect from light. Do not freeze. Discard if the vaccine has been frozen. Do not use after expiration date.1
Choosing a vaccine based on clinical trial data alone may not give you a complete picture. Because influenza varies each year, look to both clinical trial and real-world evidence (RWE) data when choosing an influenza vaccine.20,21
RWE studies for FLUAD are relevant to FLUAD QUADRIVALENT because both products are manufactured using the same process and have overlapping compositions.1 The outcomes reported here contain information not included in the Prescribing Information.
CI=confidence interval; ER=emergency room; rVE=relative vaccine effectiveness
CI=confidence interval; ER=emergency room; rVE=relative vaccine effectiveness
Choose FLUAD QUADRIVALENT with MF59® Adjuvant for your eligible patients 65+ years2
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Influenza can have a devastating impact on adults 65 years and older1
Learn more about the burden of influenza among this age group
Explore Other Flu Vaccines in the CSL Seqirus Portfolio
Please see Important Safety Information and full US Prescribing Information on each vaccine's respective product page.
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. Grohskopf LA, et al. MMWR Recomm Rep. 2022;71(1):1-28 2. FLUAD QUADRIVALENT. Package insert. Seqirus Inc; 2022. 3. Data on file. Seqirus Inc; 2022. 4. Medicare.gov. Flu shots. Accessed September 13, 2022. https://www.medicare.gov/coverage/flushots. 5. O'Hagan DT, et al. Vaccine. 2012;30(29):4341-4348. 6. O'Hagan DT, et al. Expert Rev Vaccines. 2013;12(1):13-30. 7. Banzhoff A, et al. Influenza Other Respir Viruses. 2008;2(6):243-249. 8. Izurieta HS, et al. Clin Infect Dis. 2020;ciaa1727. 9. Izurieta HS, et al. J Infect Dis. 2020;222:278-287. 10. Boikos C, et al. Clin Infect Dis. 2021;ciab152. 11. Izurieta HS, et al. J Infect Dis. 2019;220:1255-1264. 12. Pelton SI, et al. Vaccines (Basel). 2020;8(3):E446. 13. McConeghy KW, et al. Clin Infect Dis. 2020;ciaa1233. 14. Cocchio S, et al. Vaccines. 2020;8(3):344. 15. Van Buynder PG, et al. Vaccine. 2013;31(51):6122-6128. 16. Mannino S, et al. Am J Epidemiol. 2012;176(6):527-533. 17. Lapi F, et al. Expert Rev Vaccines. 2019;18(6):663-670. 18. Pelton SI, et al. Vaccine. 2021;39(17):2396-2407. 19. van Aalst R, et al. Vaccine. 2020;38(2):372-379. 20. CDC. How flu vaccine effectiveness and efficacy are measured. Accessed September 23, 2022. https://www.cdc.gov/flu/vaccines-work/effectivenessqa.htm 21. Katkade VB, et al. J Multidiscip Healthc. 2018;11:295-304. 22. CDC. Flu & people 65 years and older. Accessed August 16, 2022. https://www.cdc.gov/flu/highrisk/65over.htm