DRUGS & SUPPLEMENTS
What is the dose of the medication you are taking?
Fluzone® High-Dose is a vaccine indicated for active immunization for the prevention of Fluad disease caused by Fluad A subtype viruses and type B virus contained in the vaccine.
Fluad is approved for use in persons 65 years of age and older.
Fluad is a vaccine indicated for active immunization for the prevention of Fluad disease caused by Fluad A subtype viruses and type B virus contained in the vaccine. (1)
Fluad is approved for use in persons 65 years of age and older. (1)
A single 0.5 mL dose for intramuscular injection in adults 65 years of age and older.
Fluad should be administered as a single 0.5 mL injection by the intramuscular route in adults 65 years of age and older.
Inspect Fluad visually for particulate matter and/or discoloration prior to administration. If either of these conditions exist, the vaccine should not be administered.
Before administering a dose of vaccine, shake the prefilled syringe.
The preferred site for intramuscular injection is the deltoid muscle. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.
Do not administer this product intravenously or subcutaneously.
Fluad should not be combined through reconstitution or mixed with any other vaccine.
Fluad is a suspension for injection.
Fluad is supplied in prefilled syringes (gray syringe plunger rod), 0.5 mL, for adults 65 years of age and older.
Suspension for injection in prefilled syringe (gray plunger rod), 0.5 mL. (3)
A severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine [see Description (11) ], including egg protein, or to a previous dose of any Fluad vaccine is a contraindication to administration of Fluad.
Severe allergic reaction to any component of the vaccine, including egg protein, or after previous dose of any Fluad vaccine. (4)
If Guillain-Barré syndrome (GBS) has occurred within 6 weeks following previous Fluad vaccination, the decision to give Fluad should be based on careful consideration of the potential benefits and risks. The 1976 swine Fluad vaccine was associated with an elevated risk of GBS. Evidence for a causal relation of GBS with other Fluad vaccines is inconclusive; if an excess risk exists, it is probably slightly more than 1 additional case per 1 million persons vaccinated.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
If Fluad is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be obtained.
Vaccination with Fluad may not protect all recipients.
To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 at 1-800-822-2463 (1-800-VACCINE) or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trial(s) of a vaccine cannot be directly compared to rates in the clinical trial(s) of another vaccine and may not reflect the rates observed in practice.
Two clinical studies have evaluated the safety of Fluad.
Study 1 (NCT00391053, see http://clinicaltrials.gov) was a multi-center, double-blind pre-licensure trial conducted in the US. In this study, adults 65 years of age and older were randomized to receive either Fluad or Fluzone (2006-2007 formulation). The study compared the safety and immunogenicity of Fluad to those of Fluzone. The safety analysis set included 2573 Fluad recipients and 1260 Fluzone recipients.
Table 1 summarizes solicited injection-site reactions and systemic adverse events reported within 7 days post-vaccination via diary cards. Onset was usually within the first 3 days after vaccination and a majority of the reactions resolved within 3 days. Solicited injection-site reactions and systemic adverse events were more frequent after vaccination with Fluad compared to Fluzone.
|Fluad (N |
|Fluzone (N |
|Any||Moderate ||Severe ||Any||Moderate ||Severe |
| Fever ||3.6||1.1||0.0||2.3||0.2||0.1|
Within 6 months post-vaccination, 156 (6.1%) Fluad recipients and 93 (7.4%) Fluzone recipients experienced a serious adverse event (SAE). No deaths were reported within 28 days post-vaccination. A total of 23 deaths were reported during Days 29 – 180 post-vaccination: 16 (0.6%) among Fluad recipients and 7 (0.6%) among Fluzone recipients. The majority of these participants had a medical history of cardiac, hepatic, neoplastic, renal, and/or respiratory diseases. These data do not provide evidence for a causal relationship between deaths and vaccination with Fluad.
Study 2 (NCT01427309, see http://clinicaltrials.gov) was a multi-center, double-blind post-licensure efficacy trial conducted in the US and Canada over two Fluad seasons. In this study, adults 65 years of age and older were randomized to receive either Fluad or Fluzone (2011-2012 and 2012-2013 formulations). The study compared the efficacy and safety of Fluad to those of Fluzone. The safety analysis set included 15,992 Fluad recipients and 15,991 Fluzone recipients.
Within the study surveillance period (approximately 6 to 8 months post-vaccination), 1323 (8.3%) Fluad recipients and 1442 (9.0%) Fluzone recipients experienced an SAE. Within 30 days post-vaccination, 204 (1.3%) Fluad recipients and 200 (1.3%) Fluzone recipients experienced an SAE. The majority of these participants had one or more chronic comorbid illnesses. A total of 167 deaths were reported within 6 to 8 months post-vaccination: 83 (0.5%) among Fluad recipients and 84 (0.5%) among Fluzone recipients. A total of 6 deaths were reported within 30 days post-vaccination: 6 (0.04%) among Fluad recipients and 0 (0 %) among Fluzone recipients. These data do not provide evidence for a causal relationship between deaths and vaccination with Fluad.
The following events have been spontaneously reported during the post-approval use of Fluzone or Fluad. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Adverse events were included based on one or more of the following factors: severity, frequency of reporting, or strength of evidence for a causal relationship to Fluzone or Fluad.
Events Reported During Post-Approval Use of Fluzone.
Other Events Reported During Post-Approval Use of Fluad.
Data evaluating the concomitant administration of Fluad with other vaccines are not available.
Safety and effectiveness of Fluad has not been established in pregnant women.
Pregnancy Category C: Animal reproduction studies have not been conducted with Fluad. It is also not known whether Fluad can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluad should be given to a pregnant woman only if clearly needed.
Safety and effectiveness of Fluad in persons <65 years of age have not been established.
Safety, immunogenicity, and efficacy of Fluad have been evaluated in adults 65 years of age and older. [See Adverse Reactions (6.1) and Clinical Studies (14) ]
Fluad (Influenza Vaccine) for intramuscular injection is an inactivated Fluad vaccine, prepared from Fluad viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Fluad virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a "split virus". The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluad process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration.
Fluad suspension for injection is clear and slightly opalescent in color.
Neither antibiotics nor preservative are used in the manufacture of Fluad.
The Fluad prefilled syringe presentation is not made with natural rubber latex.
Fluad is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three Fluad strains recommended for the 2017-2018 Fluad season: A/Michigan/45/2015 X-275 (H1N1), A/Hong Kong/4801/2014 X-263-B(H3N2), and B/Brisbane/60/2008(B Victoria Lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 2.
0.5 mL Dose
| Active Substance: Split Fluad virus, inactivated strains ||180 mcg HA total|
|A (H1N1)||60 mcg HA|
|A (H3N2)||60 mcg HA|
|B||60 mcg HA|
|Sodium phosphate-buffered isotonic sodium chloride solution||QS |
|Octylphenol ethoxylate||≤250 mcg|
Fluad illness and its complications follow infection with Fluad viruses. Global surveillance of Fluad identifies yearly antigenic variants. For example, since 1977, antigenic variants of Fluad A (H1N1 and H3N2) viruses and Fluad B viruses have been in global circulation. Specific levels of hemagglutination inhibition (HI) antibody titer post-vaccination with inactivated Fluad virus vaccines have not been correlated with protection from Fluad virus infection. In some human studies, antibody titers ≥1:40 have been associated with protection from Fluad illness in up to 50% of participants.
Antibodies against one Fluad virus type or subtype confer limited or no protection against another. Furthermore, antibodies to one antigenic variant of Fluad virus might not protect against a new antigenic variant of the same type or subtype. Frequent development of antigenic variants through antigenic drift is the virologic basis for seasonal epidemics and the reason for the usual change of one or more new strains in each year's Fluad vaccine. Therefore, Fluad vaccines are standardized to contain the hemagglutinins of Fluad virus strains representing the Fluad viruses likely to be circulating in the US during the Fluad season.
Annual vaccination with the current vaccine is recommended because immunity during the year after vaccination declines and because circulating strains of Fluad virus change from year to year.
Fluad has not been evaluated for carcinogenic or mutagenic potential or for impairment of fertility.
Study 1 was a multi-center, double-blind pre-licensure trial conducted in the US in which adults 65 years of age and older were randomized to receive either Fluad or Fluzone (2006-2007 formulation). The study compared the safety and immunogenicity of Fluad to those of Fluzone. For immunogenicity analyses, 2576 participants were randomized to Fluad and 1275 participants were randomized to Fluzone. Females accounted for 51.3% of participants in the Fluad group and 54.7% of participants in the Fluzone group. In both groups, the mean age was 72.9 years (ranged from 65 through 97 years in the Fluad group and 65 through 94 years in the Fluzone group); 35% of participants in the Fluad group and 36% of participants in the Fluzone group were 75 years of age or older. Most participants in the Fluad and Fluzone groups, respectively, were White (91.7% and 92.9%), followed by Hispanic (4.8% and 3.7%), and Black (2.7% and 2.7%).
The primary endpoints of the study were HI GMTs and seroconversion rates 28 days after vaccination. Pre-specified statistical superiority criteria required that the lower limit (LL) of the 2-sided 95% CI of the GMT ratio (Fluzone High-Dose/Fluzone) be greater than 1.50 for at least two of the strains, and if one strain failed, non-inferiority of that strain must be demonstrated (LL>0.67), and that the lower limit of the 2-sided 95% CI of the seroconversion rate difference (Fluzone High-Dose minus Fluzone) be greater than 10% for at least two of the strains, and if one strain failed, non-inferiority of that strain must be demonstrated (LL>-10%). As shown in Table 3, statistically superior HI GMTs and seroconversion rates after vaccination with Fluad compared to Fluzone were demonstrated for Fluad A subtypes, A (H1N1) and A (H3N2), but not for Fluad type B. For strain B, non-inferiority of Fluad compared to Fluzone was demonstrated for both the HI GMTs and seroconversion rates.
|Fluad Strain||GMT||GMT Ratio||Seroconversion % ||Difference||Met Both Pre-defined Superiority Criteria |
|Fluad over Fluzone |
|Fluad minus Fluzone |
|A (H1N1)||115.8 ||67.3 ||1.7 |
|48.6 ||23.1 ||25.4 |
|A (H3N2)||608.9 ||332.5 ||1.8 |
|69.1 ||50.7 ||18.4 |
|B||69.1 ||52.3 ||1.3 |
|41.8 ||29.9 ||11.8 |
Study 2 (NCT01427309) was a multi-center, double-blind post-licensure efficacy trial conducted in the US and Canada in which adults 65 years of age and older were randomized (1:1) to receive either Fluad or Fluzone. The study was conducted over two Fluad seasons (2011-2012 and 2012-2013); 53% of participants enrolled in the first year of the study were re-enrolled and re-randomized in the second year. The per-protocol analysis set for efficacy assessments included 15,892 Fluad recipients and 15,911 Fluzone recipients. The majority (67%) of participants in the per-protocol analysis set for efficacy had one or more high-risk chronic comorbid conditions.
In the per-protocol analysis set, females accounted for 57.2% of participants in the Fluad group and 56.1% of participants in the Fluzone group. In both groups, the median age was 72.2 years (range 65 through 100 years). Overall, most participants in the study were White (95%); approximately 4% of study participants were Black, and approximately 6% reported Hispanic ethnicity.
The primary endpoint of the study was the occurrence of laboratory-confirmed Fluad (as determined by culture or polymerase chain reaction) caused by any Fluad viral type/subtype in association with influenza-like illness (ILI), defined as the occurrence of at least one of the following respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing; concurrent with at least one of the following systemic signs or symptoms: temperature >99.0°F, chills, tiredness, headaches or myalgia. Participants were monitored for the occurrence of a respiratory illness by both active and passive surveillance, starting 2 weeks post-vaccination for approximately 7 months. After an episode of respiratory illness, nasopharyngeal swab samples were collected for analysis; attack rates and vaccine efficacy were calculated.
|Relative Efficacy |
% (95% CI)
| Any type/subtype ||227 (1.43)||300 (1.89)||24.2 (9.7; 36.5) |
|Fluad A||190 (1.20)||249 (1.56)||23.6 (7.4; 37.1)|
|A (H1N1)||8 (0.05)||9 (0.06)||11.0 (-159.9; 70.1)|
|A (H3N2)||171 (1.08)||222 (1.40)||22.9 (5.4; 37.2)|
| Fluad B ||37 (0.23)||51 (0.32)||27.4 (-13.1; 53.8)|
A secondary endpoint of the study was the occurrence of culture-confirmed Fluad caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations in association with a modified CDC-defined ILI, defined as the occurrence of a temperature > 99.0°F (> 37.2°C) with cough or sore throat. The efficacy of Fluad relative to Fluzone for this endpoint was 51.1% (95% CI: 16.8; 72.0).
Single-dose, prefilled syringe, without needle, 0.5 mL (not made with natural rubber latex). Supplied as package of 10 (NDC 49281-401-65).
Store Fluad refrigerated at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Discard if vaccine has been frozen.
Do not use after the expiration date shown on the label.
Fluzone is a registered trademark of Sanofi Pasteur Inc.
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA
Patient Information Sheet
Please read this information sheet before getting Fluad vaccine. This summary is not intended to take the place of talking with your healthcare provider. If you have questions or would like more information, please talk with your healthcare provider.
What is Fluad vaccine?
Fluad is a vaccine that helps protect against Fluad illness (flu).
Fluad vaccine is for people 65 years of age and older.
Vaccination with Fluad vaccine may not protect all people who receive the vaccine.
Who should not get Fluad vaccine?
You should not get Fluad vaccine if you:
Tell your healthcare provider if you have or have had:
How is Fluad vaccine given?
Fluad vaccine is a shot given into the muscle of the arm.
What are the possible side effects of Fluad vaccine?
The most common side effects of Fluad vaccine are:
These are not all of the possible side effects of Fluad vaccine. You can ask your healthcare provider for a list of other side effects that is available to healthcare professionals.
Call your healthcare provider for advice about any side effects that concern you. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov.
Why should I get Fluad vaccine instead of Fluzone vaccine?
An efficacy study in adults 65 years of age and older has demonstrated that Fluad vaccine offers better protection against Fluad than Fluzone vaccine.
What are the ingredients in Fluad vaccine?
Fluad vaccine contains 3 killed flu virus strains.
Inactive ingredients include formaldehyde and octylphenol ethoxylate.
Manufactured by: Sanofi Pasteur Inc.
Swiftwater, PA 18370 USA
Depending on the reaction of the Fluad after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Fluad not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Fluad addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology