Vaccine Information: FLUZONE High-Dose Quadrivalent

FLUZONE HIGH-DOSE QUADRIVALENT- influenza a virus a/michigan/45/2015 x-275 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/singapore/infimh-16-0019/2016 ivr-186 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated) and influenza b virus b/maryland/15/2016 bx-69a antigen (formaldehyde inactivated) injection, suspension
Sanofi Pasteur Inc.

1 INDICATIONS AND USAGE

Fluzone® High-Dose Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza caused by influenza A subtype viruses and type B viruses contained in the vaccine.

Fluzone High-Dose Quadrivalent is indicated for use in persons 65 years of age and older.

2 DOSAGE AND ADMINISTRATION

For intramuscular use only

2.1 Dose and Schedule

Fluzone High-Dose Quadrivalent should be administered as a single 0.7 mL injection by the intramuscular route in adults 65 years of age and older.

2.2 Administration

Inspect Fluzone High-Dose Quadrivalent visually for particulate matter and/or discoloration prior to administration. If either of these conditions exists 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.

Fluzone High-Dose Quadrivalent should not be combined through reconstitution or mixed with any other vaccine.

3 DOSAGE FORMS AND STRENGTHS

Fluzone High-Dose Quadrivalent is a suspension for injection.

Fluzone High-Dose Quadrivalent is supplied in prefilled syringes, 0.7 mL, for adults 65 years of age and older.

4 CONTRAINDICATIONS

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 influenza vaccine is a contraindication to administration of Fluzone High-Dose Quadrivalent.

5 WARNINGS AND PRECAUTIONS

5.1 Guillain-Barré Syndrome

If Guillain-Barré syndrome (GBS) has occurred within 6 weeks following any previous influenza vaccination, the decision to give Fluzone High-Dose 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. Evidence for a causal relation 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. GBS has also been temporally associated with influenza disease. (See references 1 and 2.)

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

If Fluzone High-Dose Quadrivalent is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be lower than expected.

5.4 Limitations of Vaccine Effectiveness

Vaccination with Fluzone High-Dose Quadrivalent may not protect all recipients.

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

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. One clinical study has evaluated the safety of Fluzone High-Dose Quadrivalent.

Study 1 (NCT03282240, see https://clinicaltrials.gov) was a randomized, active-controlled, modified double-blind pre-licensure trial conducted in the U.S. The study compared the safety and immunogenicity of Fluzone High-Dose Quadrivalent to those of Fluzone High-Dose (trivalent formulation). The safety analysis set included 1777 Fluzone High-Dose Quadrivalent recipients, 443 Fluzone High-Dose recipients, and 450 investigational Fluzone High-Dose containing the alternate B influenza strain recipients.

The most common reactions occurring after Fluzone High-Dose Quadrivalent administration were injection-site pain (41.3%), myalgia (22.7%), headache (14.4%), and malaise (13.2%). Onset usually occurred within the first 3 days after vaccination. The majority of solicited reactions resolved within three days of vaccination.

Table 1 displays solicited adverse reactions for Fluzone High-Dose Quadrivalent compared to Fluzone High-Dose reported within 7 days after vaccination and collected using standardized diary cards.

Table 1: Study 1*: Frequency of Solicited Injection-Site Reactions and Systemic Adverse Events within 7 Days after Vaccination with Fluzone High-Dose Quadrivalent or Fluzone High-Dose, Adults 65 Years of Age and Older
Fluzone High-Dose Quadrivalent (N =1761-1768) Fluzone High-Dose (N =885-889)
Percentage Percentage
Any Grade 3 Any Grade 3
*
NCT03282240
N is the number of vaccinated participants with available data for the events listed
Safety results for the Fluzone High-Dose and investigational Fluzone High-Dose containing the alternate B influenza strain recipients were pooled for the analysis.
§
Grade 3: A type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
Grade 3: > 100 mm
#
Grade 3: ≥ 102.1°F (39.0°C)
Local Reactions
Injection Site Pain § 41.3 0.7 36.4 0.2
Injection Site Erythema 6.2 0.6 5.7 0.2
Injection Site Swelling 4.9 0.3 4.7 0.1
Injection Site Induration 3.7 0.2 3.5 0.1
Injection Site Bruising 1.3 0.0 1.1 0.0
Systemic Reactions
Myalgia § 22.7 0.9 18.9 0.7
Headache § 14.4 0.6 13.6 0.4
Malaise § 13.2 0.7 13.4 0.4
Shivering § 5.4 0.3 4.7 0.3
Fever # 0.4 0.2 0.9 0.2

Based on data from Fluzone High-Dose, solicited injection site reactions and systemic adverse reactions were slightly more frequent after vaccination with Fluzone High-Dose compared to a standard-dose vaccine.

Unsolicited non-serious adverse events were reported in 279 (15.7%) recipients in the Fluzone High-Dose Quadrivalent group and 140 (15.7%) recipients in the Fluzone High-Dose group. The most commonly reported unsolicited adverse event was cough.

Within 180 days post-vaccination, 80 (4.5%) Fluzone High-Dose Quadrivalent recipients and 48 (5.4%) Fluzone High-Dose recipients experienced a serious adverse event (SAE). None of the SAEs were assessed as related to the study vaccines.

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