Adding MF59® Adjuvant to an influenza vaccine is designed to strengthen, broaden, and lengthen the duration of the immune response.4-6

Learn more about MF59® Adjuvant technologyNext screen Key Features
  • Made with MF59® Adjuvant1
  • Preservative free1
  • For intramuscular injection1
  • 0.5-mL pre-filled syringe1
  • 10 syringes per carton1
  • Syringe, plunger, and tip cap are not made from natural rubber latex1

product image

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.1

fluad sales aid chart

Tap to see full chart

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

Tap to see full chart

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

20+ years of RWE studies support the clinical effectiveness of FLUAD® (Influenza Vaccine, Adjuvanted) in adults 65+7-18

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.19,20

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.

FLUAD VS A HIGH-DOSE (HD) INFLUENZA VACCINE
RWE studies from across 4 US influenza seasons with different study designs, outcomes, and study limitations assessed the rVE of FLUAD compared with a high-dose influenza vaccine.7-11,17,18
2% fewer influenza-related hospitalization encounters with FLUAD7
(rVE 1.6%; 95% CI -1.6, 4.8)
Design:Retrospective cohort study, 9.7 million adults ≥65 years, US 2019-2020 season
Limitations:Potential for residual confounding; lack of laboratory confirmation
STUDY 1
3% fewer influenza-related hospitalization encounters with FLUAD8
(rVE 3%; 95% CI 0, 6.1)
Design:Retrospective cohort study, 10 million adults ≥65 years, US 2018-2019 season
Limitations:Potential for residual confounding; lack of laboratory confirmation
STUDY 2
7% fewer influenza-related office visits with FLUAD17
(rVE 6.6%; 95% CI 2.7, 10.3)
2% fewer influenza-related hospitalizations and ER visits with FLUAD17
(rVE 2%; 95% CI -3.7, 7.3)
Design:Retrospective cohort study, 2.2 million adults ≥65 years, US 2018-2019 season
Limitations:Results were not adjusted by unmeasurable confounders; lack of laboratory confirmation
STUDY 3
7% fewer influenza-related medical encounters with FLUAD9
(rVE 6.9%; 95% CI 3.1, 10.6)
Design:Retrospective cohort study, 4.8 million adults ≥65 years, US 2018-2019 season
Limitations:Results were not adjusted by unmeasurable confounders; lack of laboratory confirmation
STUDY 1
17% fewer influenza-related office visits with FLUAD11
(rVE 16.6%; 95% CI 10.8, 22)
3% fewer influenza-related hospitalizations and ER visits with FLUAD11
(rVE 3.2%; 95% CI -2.7, 8.9)
2% fewer other respiratory hospitalizations and ER visits with FLUAD11
(rVE 2.4%; 95% CI 0.7, 4)
Design:Retrospective cohort study, 1.5 million adults ≥65 years, US 2017-2018 season
Limitations:Results were not adjusted by unmeasurable and unobservable confounders; stringent influenza-related office visit definition
STUDY 2
Did not reduce the risk of influenza-related hospitalization encounters vs HD10
(rVE -5.3%; 95% CI -7.3, -3.3)
Design:Retrospective cohort study, 9.9 million adults ≥65 years, US 2017-2018 season
Limitations:Potential for residual confounding; Medicare claims may not be representative of private or uninsured populations
STUDY 3
8% fewer influenza-related medical encounters with FLUAD9
(rVE 7.7%; 95% CI 2.3, 12.8)
Design:Retrospective cohort study, 3.9 million adults ≥65 years, US 2017-2018 season
Limitations:Results were not adjusted by unmeasurable confounders; lack of laboratory confirmation
Did not reduce the risk of influenza-related hospitalization encounters vs HD18
(rVE -12%; 95% CI -20, -3.3)
Design:Retrospective cohort study, over 2.1 million adults ≥65 years, US, 2 consecutive seasons (2016-2017 & 2017-2018)
Limitations:Results were unable to be adjusted for unobservable confounders; uneven cohort sizes between the seasons made results heavily influenced by 2017-2018 season

CI=confidence interval; ER=emergency room; rVE=relative vaccine effectiveness

FLUAD VS STANDARD-DOSE (SD) INFLUENZA VACCINES
RWE study results from across 18 influenza seasons with different study designs, outcomes, and study limitations favored FLUAD—estimating that FLUAD reduced the risk of flu-related clinical outcomes compared with standard-dose influenza vaccines.7-16
8% fewer influenza-related hospitalization encounters with FLUAD7
(rVE 8.2%; 95% CI 4.2-12)
Design:Retrospective cohort study, over 4.1 million adults ≥65 years, US 2019-2020 season
Limitations:Potential for residual confounding; lack of laboratory confirmation
STUDY 1
8% fewer influenza-related hospitalization encounters with FLUAD8
(rVE 7.7%; 95% CI 3.9-11.14)
Design:Retrospective cohort study, over 3.5 million adults ≥65 years, US 2018-2019 season
Limitations:Potential for residual confounding; lack of laboratory confirmation
STUDY 2
28% fewer influenza-related medical encounters with FLUAD9
(rVE 27.8%; 95% CI 25.7-29.9)
Design:Retrospective cohort study, over 1.9 million adults ≥65 years, US 2018-2019 season
Limitations:Unmeasurable confounders; lack of laboratory confirmation
STUDY 1
36% fewer influenza-related office visits with FLUAD11
(rVE 36.3%; 95% CI 31-41.2)
9% fewer influenza-related hospitalizations and ER visits with FLUAD11
(rVE 8.6%; 95% CI 1.2-15.6)
4% fewer cardio-respiratory hospitalizations and ER visits with FLUAD11
(rVE 4%; 95% CI 1.9-6.2)
Design:Retrospective cohort study, 446,600 adults ≥65 years, US 2017-2018 season
Limitations:Potential for residual confounding; stringent influenza-related office visit definition
STUDY 2
18% fewer influenza-related medical encounters with FLUAD9
(rVE 18.2%; 95% CI 15.8-20.5)
Design:Retrospective cohort study, over 1.4 million adults ≥65 years, US 2017-2018 season
Limitations:Unmeasurable confounders; lack of laboratory confirmation
STUDY 3
4% fewer influenza-related hospitalization encounters with FLUAD10
(rVE 3.9%; 95% CI 1.4-6.3)
Design:Retrospective cohort study, over 3.2 million adults ≥65 years, US 2017-2018 season
Limitations:Potential for residual confounding; Medicare claims may not be representative of private or uninsured populations
6% fewer all-cause hospitalizations with FLUAD12
(rVE 6%; 95% CI 1-11)
Design:Prospective, randomized study, 50,012 nursing home residents, US 2016-2017 season
Limitations:Study population may not represent US older adults; lower frequency of events
33% fewer hospitalizations for pneumonia with FLUAD13
(rVE 33%; 95% CI 25-41)
Design:Retrospective cohort study, 479,397 adults ≥65 years, Italy, 6 consecutive season (2011-2012 through 2016-2017)
Limitations:Lack of unvaccinated control group; Lack of laboratory confirmation
63% fewer laboratory-confirmed influenza illnesses with FLUAD8
(rVE 63%; 95% CI 4-86)
Design:Prospective, case-control study, 227 adults ≥65 years, Canada 2011-2012 season
Limitations:Small study population; low numbers prevented the evaluation of hospitalizations
25% fewer influenza or pneumonia-related hospitalizations with FLUAD15
(rVE 25%; 95% CI 2-43)
Design:Prospective, observational, population-based cohort study, 107,661 adults ≥65 years, Italy, 3 consecutive seasons (2006-2007 through 2008-2009)
Limitations:Underestimated rVE as FLUAD subjects were more frail; potential residual confounding
39% fewer hospitalizations for pneumonia and cerebrovascular and/or cardiovascular events with FLUAD16
(rVE 39%; 95% CI 4-61)
Design:Retrospective, case-controlled study, 43,000 adults ≥65 years, Italy, 15 consecutive seasons (2001-2002 through 2016-2017)
Limitations:Underutilization of laboratory influenza diagnostics; lower frequency of events

CI=confidence interval; ER=emergency room; rVE=relative vaccine effectiveness

product logo

Choose FLUAD QUADRIVALENT with MF59® Adjuvant for your eligible patients 65+ years1

Order now

Influenza can have a devastating impact on adults 65 years and older7

Learn more about the burden of influenza among this age groupNext screen

Explore Other Flu Vaccines in the Seqirus Portfolio

Please see Important Safety Information and full US Prescribing Information on each vaccine's respective product page.

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

Vaccination with FLUAD QUADRIVALENT, AFLURIA QUADRIVALENT or FLUCELVAX 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%).

AFLURIA QUADRIVALENT:

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

In adults 65 years of age and older, the most commonly reported injection-site adverse reaction was pain (≥ 20%). The most common systemic adverse event was myalgia (≥ 10%).
In children 5 through 8 years, the most commonly reported injection-site adverse reactions 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 were pain (≥ 50%), redness and swelling (≥ 10%). The most common systemic adverse events were headache, myalgia, and malaise and fatigue (≥ 10%).

In children 6 months through 35 months of age, the most commonly reported injection-site reactions 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 were pain (≥ 30%) and redness (≥ 20%). The most commonly reported systemic adverse events were malaise and fatigue, and diarrhea (≥ 10%).

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 with AFLURIA (trivalent formulation) when administered by 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%).

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%).

To report SUSPECTED ADVERSE REACTIONS, contact 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, AFLURIA QUADRIVALENT and FLUCELVAX QUADRIVALENT.

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

PharmaJet® and STRATIS® are registered trademarks of PharmaJet.

References:

1. FLUAD QUADRIVALENT. Package insert. Seqirus Inc; 2021. 2. Data on file. Seqirus Inc; 2020. 3. Medicare.gov. Flu shots. Accessed February 12, 2021. https://www.medicare.gov/coverage/flushots. 4. O’Hagan DT, et al. Vaccine. 2012;30(29):4341-4348. 5. O’Hagan DT, et al. Expert Rev Vaccines. 2013;12(1):13-30. 6. Banzhoff A, et al. Influenza Other Respir Viruses.2008;2(6):243-249. 7. Izurieta HS, et al. Clin Infect Dis. 2020;ciaa1727. 8. Izurieta HS, et al. J Infect Dis. 2020;222:278-287. 9. Boikos C, et al. Clin Infect Dis. 2021;ciab152. 10. Izurieta HS, et al. J Infect Dis. 2019;220:1255-1264. 11. Pelton SI, et al. Vaccines (Basel). 2020;8(3):E446. 12. McConeghy KW, et al. Clin Infect Dis. 2020;ciaa1233. 13. Cocchio S, et al. Vaccines. 2020;8(3):344. 14. Van Buynder PG, et al. Vaccine. 2013;31(51):6122-6128. 15. Mannino S, et al. Am J Epidemiol. 2012;176(6):527-533. 16. Lapi F, et al. Expert Rev Vaccines. 2019;18(6):663-670. 17. Pelton SI, et al. Vaccine. 2021;39(17):2396-2407. 18. van Aalst R, et al. Vaccine. 2020;38(2):372-379. 19. CDC. How flu vaccine effectiveness and efficacy are measured. Accessed April 22, 2021. https://www.cdc.gov/flu/vaccines-work/effectivenessqa.htm 20. Katkade VB, et al. J Multidiscip Healthc. 2018;11:295-304.