Choose an adjuvanted vaccine to help prevent seasonal influenza
FLUAD® QUADRIVALENT is the first-and-only adjuvanted quadrivalent seasonal influenza vaccine1
APPROVED FOR PATIENTS65+ YEARS1
155 million doses distributed over 20+ years*2Order Today
*Doses distributed globally as of September 2020 and includes both FLUAD and FLUAD QUADRIVALENT.
Adding MF59® Adjuvant to an influenza vaccine is designed to strengthen, broaden, and lengthen the duration of the immune response.4-6Learn more about MF59® Adjuvant technology 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
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
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
Choose FLUAD QUADRIVALENT with MF59® Adjuvant for your eligible patients 65+ years1Order now
Influenza can have a devastating impact on adults 65 years and older7Learn more about the burden of influenza among this age group
IMPORTANT SAFETY INFORMATION
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.
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 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%).
In adults 18 through 64 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were pain (≥ 40%), erythema and induration (≥ 10%). The most common systemic adverse events were headache, fatigue and myalgia (≥ 10%).
In adults ≥ 65 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were pain (≥ 20%) and erythema (≥ 10%).
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 events 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 events were headache (18.1%) and fatigue (17.0%).
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.
1. FLUAD QUADRIVALENT. Package insert. Seqirus Inc; 2021. 2. Data on file. Seqirus Inc; 2021. 3. Medicare.gov. Flu shots. Accessed February 12, 2021. https://www.medicare.gov/coverage/flushots. 4. O'Hagan DT, Ott GS, De Gregorio E, Seubert A. The mechanism of action of MF59 - an innately attractive adjuvant formulation. Vaccine. 2012;30(29):4341-4348. doi:10.1016/j.vaccine.2011.09.061. 5. O'Hagan DT, Ott GS, Nest GV, Rappuoli R, Del Giudice G. The history of MF59® adjuvant: a phoenix that arose from the ashes. Expert Rev Vaccines. 2013;12(1):13-30. doi:10.1586/erv.12.140 6. Banzhoff A, Pellegrini M, Del Giudice G, Fragapane E, Groth N, Podda A. MF59-adjuvanted vaccines for seasonal and pandemic influenza prophylaxis. Influenza Other Respir Viruses. 2008;2(6):243-249. doi:10.1111/j.1750-2659.2008.00059.x