Vaccine Information: FLUAD QUADRIVALENT

FLUAD QUADRIVALENT- influenza a virus a/victoria/2454/2019 ivr-207 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/hong kong/2671/2019 ivr-208 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/victoria/705/2018 bvr-11 antigen (formaldehyde inactivated) and influenza b virus b/phuket/3073/2013 bvr-1b antigen (formaldehyde inactivated) injection, suspension
Seqirus, Inc.

1 INDICATIONS AND USAGE

FLUAD QUADRIVALENT is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. FLUAD QUADRIVALENT is approved for use in persons 65 years of age and older. This indication is approved under accelerated approval based on the immune response elicited by FLUAD QUADRIVALENT [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only

2.1. Dosage and Schedule

Administer FLUAD QUADRIVALENT as a single 0.5 mL intramuscular injection in adults 65 years of age and older.

2.2. Administration

  • Gently shake each syringe. FLUAD QUADRIVALENT has a milky-white appearance. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit [see Description (11)]. If either condition exists, FLUAD QUADRIVALENT should not be administered.
  • To use a pre-filled syringe fitted with a Luer Lok system, remove the tip cap by unscrewing it in a counter-clockwise direction. Once the tip cap is removed, attach a needle to the syringe by screwing it on in a clockwise direction until it locks. Once the needle is locked in place, remove the needle protector and administer the vaccine.
  • The vaccine should be administered by intramuscular injection, preferably in the region of the deltoid muscle of the upper arm. Do not inject the vaccine in the gluteal region or areas where there may be a major nerve trunk.

3 DOSAGE FORMS AND STRENGTHS

FLUAD QUADRIVALENT is a sterile injectable emulsion supplied in 0.5 mL single-dose pre-filled syringes.

4 CONTRAINDICATIONS

Do not administer FLUAD QUADRIVALENT to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine, including egg protein [see Description (11)] , or to a previous influenza vaccine.

5 WARNINGS AND PRECAUTIONS

5.1. Guillain-Barré Syndrome

If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLUAD QUADRIVALENT should be based on careful consideration of the potential benefits and risks. The 1976 swine influenza vaccine was associated with an elevated risk of GBS. [see References (1)] Evidence for a causal relationship of GBS with other influenza vaccines is inconclusive; if an excess risk exists, it is probably slightly more than 1 additional case per 1 million persons vaccinated.

5.2. Preventing and Managing Allergic Reactions

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

5.3 Altered Immunocompetence

The immune response to FLUAD QUADRIVALENT in immunocompromised persons, including individuals receiving immunosuppressive therapy, may be lower than in immunocompetent individuals. [see Concurrent Use With Immunosuppressive Therapies (7.2)]

5.4 Syncope

Syncope (fainting) may occur in association with administration of injectable vaccines including FLUAD QUADRIVALENT. Ensure procedures are in place to avoid injury from falling associated with syncope.

5.5 Limitations of Vaccine Effectiveness

Vaccination with FLUAD QUADRIVALENT may not protect all vaccine recipients against influenza disease.

6 ADVERSE REACTIONS

The most common (≥10%) local and systemic reactions in elderly subjects 65 years of age and older were injection site pain (16.3%), headache (10.8%) and fatigue (10.5%).

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect rates observed in clinical practice.

The safety of FLUAD QUADRIVALENT was evaluated in two clinical studies in 4269 elderly subjects 65 years of age and older. Study 1 (NCT02587221) was a multi-center, randomized, observer-blind, non-influenza comparator-controlled efficacy and safety study conducted in 12 countries during the 2016-2017 Northern Hemisphere and 2017 Southern Hemisphere seasons. In this study, 3381 subjects received FLUAD QUADRIVALENT and 3380 subjects received a US-licensed non-influenza comparator vaccine (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Boostrix® [GlaxoSmithKline Biologicals]).

The mean age of subjects at enrollment was 72 years, 62% were female, 48% White, 34% Asian, 16% Other, 2% American Indian/Alaska Native, and 18% of Hispanic/Latino ethnicity.

Solicited local and systemic adverse reactions were collected for 7 days after vaccination in a subset of 665 subjects who received FLUAD QUADRIVALENT and 667 subjects who received the comparator vaccine. The percentages of subjects reporting solicited local adverse reactions are presented in Table 1a and systemic adverse reactions are presented in Table 1b. Onset usually occurred within the first 2 days after vaccination. The majority of solicited reactions resolved within 3 days.

Table 1a. Percentages of Subjects Reporting Solicited Local Adverse Reactionsa in the Solicited Safety Populationb within 7 Days of Vaccination (Study 1)

Study 1: NCT02587221

Abbreviation: N=number of subjects with solicited safety data

Non-Influenza Comparator Vaccine = combined Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Boostrix® (GlaxoSmithKline Biologicals)

a All solicited local adverse events reported within 7 days of vaccination are included

b Solicited Safety Population: all subjects in the exposed population who received a study vaccine and provided post-vaccination solicited safety data

c Severe 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, = prevents daily activity.

Local (Injection site) Reactions c FLUAD QUADRIVALENT N=595-659 Non-Influenza Comparator Vaccine N=607-664
Injection site pain 16.3 11.2
Erythema ≥25mm 3.8 1.8
Induration ≥25mm 4.0 2.6
Ecchymosis ≥25mm 0.5 0.7
Table 1b. Percentages of Subjects Reporting Solicited Systemic Adverse Reactionsa in the Solicited Safety Populationb within 7 Days of Vaccination (Study 1)

Study 1: NCT02587221

Abbreviation: N=number of subjects with solicited safety data

Non-Influenza Comparator Vaccine = combined Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Boostrix® (GlaxoSmithKline Biologicals)

a All solicited systemic adverse events reported within 7 days of vaccination are included

b Solicited Safety Population: all subjects in the exposed population who received a study vaccine and provided post-vaccination solicited safety data

c Severe 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: 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).

Systemic Reactions c FLUAD QUADRIVALENT N=595-659 Non-Influenza Comparator Vaccine N=607-664
Headache 10.8 8.3
Fatigue 10.5 8.8
Myalgia 7.7 6.1
Arthralgia 7.3 6.6
Chills 5.0 3.9
Diarrhea 4.1 3.0
Nausea 3.8 2.3
Loss of appetite 3.6 3.6
Fever ≥100.4°F (38°C) 1.7 1.2
Vomiting 0.8 1.1

Unsolicited adverse events (AEs) were collected for all subjects for 21 days after vaccination. Related unsolicited AEs were reported by 303 (9.0%) and by 261 (7.7%) of the subjects for FLUAD QUADRIVALENT and Boostrix, respectively. For FLUAD QUADRIVALENT, injection site pain and influenza-like illness were the only unsolicited adverse reactions reported in ≥ 1% of subjects (1.7% and 1.5%, respectively).

Serious adverse events (SAEs) and potentially immune-mediated adverse events of special interest (AESIs) were collected up to 366 days after vaccination. SAEs were reported by 238 (7.0%) FLUAD QUADRIVALENT recipients and 234 (6.9%) comparator recipients. There were no SAEs, AESIs or deaths in this study that were related to FLUAD QUADRIVALENT.

Study 2 (NCT03314662) was a multicenter, randomized, double-blind, comparator-controlled study conducted during the 2017-18 Northern Hemisphere influenza season. In this study, 888 subjects received FLUAD QUADRIVALENT, 444 subjects received the licensed adjuvanted trivalent vaccine (aTIV-1 — FLUAD® (trivalent formulation)) and 444 subjects received an adjuvanted trivalent influenza vaccine with an alternate B strain (aTIV-2).

The mean age of subjects at enrollment who received FLUAD QUADRIVALENT was 72.5 years. Female subjects represented 56.6% of the study population and the racial distribution of subjects was 91.6% Caucasian, 7.0% Black or African American, and ≤ 1% each for Asian, Native Hawaiian or Pacific Islander, American Indian or Alaska Native or Other.

Solicited local and systemic adverse reactions reported within 7 days after vaccination were similar to those reported for Study 1. Unsolicited AEs were collected for 21 days after vaccination. Related unsolicited AEs were reported by 39 (4.4%) and by 17-19 (3.8%-4.3%) of subjects administered FLUAD QUADRIVALENT or aTIV, respectively. For FLUAD QUADRIVALENT, injection site bruising (1.0%) was the only unsolicited adverse reaction reported in ≥ 1% of subjects.

Serious AEs and AESIs were collected up to 181 days after vaccination. Within 6 months after vaccination, 37 (4.2%) FLUAD QUADRIVALENT recipients and 18-28 (4.1%-6.3%) aTIV recipients experienced an SAE. There were no SAEs, AESIs or deaths in this study that were related to the study vaccine. There were no AEs leading to withdrawal from the study.

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