Vaccine Information: FLUZONE High-Dose Quadrivalent Northern Hemisphere (Page 3 of 4)

14.2 Efficacy of Fluzone High-Dose in Adults 65 Years of Age and Older

The efficacy of Fluzone High-Dose (trivalent formulation) is relevant to Fluzone High-Dose Quadrivalent since both vaccines are manufactured according to the same process and have overlapping compositions.

Study 2 (NCT01427309) was a multi-center, double-blind, post-licensure efficacy trial conducted in the U.S. and Canada in which adults 65 years of age and older were randomized (1:1) to receive either Fluzone High-Dose or Fluzone. The study was conducted over two influenza 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 Fluzone High-Dose 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 Fluzone High-Dose 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 influenza (as determined by culture or polymerase chain reaction) caused by any influenza 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 (see Table 5).

Table 5: Study 2*: Relative Efficacy Against Laboratory-Confirmed Influenza Regardless of Similarity to the Vaccine Components, Associated with Influenza-Like Illness , Adults 65 Years of Age and Older
Fluzone High-DoseN §=15,892n (%) FluzoneN §=15,911n (%) Relative Efficacy% (95% CI)
*
NCT01427309
Laboratory-confirmed: culture or polymerase-chain-reaction–confirmed
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
§
N is the number of vaccinated participants in the per-protocol analysis set for efficacy assessments
n is the number of participants with protocol-defined influenza-like illness with laboratory confirmation
#
Primary endpoint
Þ
The prespecified statistical superiority criterion for the primary endpoint (lower limit of the 2-sided 95% CI of the vaccine efficacy of Fluzone High-Dose relative to Fluzone >9.1%) was met.
ß
In the first year of the study the influenza B component of the vaccine and the majority of influenza B cases were of the Victoria lineage; in the second year the influenza B component of the vaccine and the majority of influenza B cases were of the Yamagata lineage
Any type/subtype # 227 (1.43) 300 (1.89) 24.2 (9.7; 36.5)Þ
Influenza 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)
Influenza B ß 37 (0.23) 51 (0.32) 27.4 (-13.1; 53.8)

A secondary endpoint of the study was the occurrence of culture-confirmed influenza 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 Fluzone High-Dose relative to Fluzone for this endpoint was 51.1% (95% CI: 16.8; 72.0).

15 REFERENCES

1
Lasky T, Terracciano GJ, Magder L, et al. The Guillain-Barré syndrome and the 1992-1993 and 1993-1994 influenza vaccines. N Engl J Med 1998;339:1797-802.
2
Baxter, R, et al. Lack of Association of Guillain-Barré Syndrome with Vaccinations. Clin Infect Dis 2013;57(2):197-204.
3
Hannoun C, Megas F, Piercy J. Immunogenicity and protective efficacy of influenza vaccination. Virus Res 2004;103:133-138.
4
Hobson D, Curry RL, Beare AS, Ward-Gardner A. The role of serum haemagglutination-inhibiting antibody in protection against challenge infection with influenza A2 and B viruses. J Hyg Camb 1972;70:767-777.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Single-dose, prefilled syringe, without needle, 0.7 mL (NDC 49281-121-88) (not made with natural rubber latex). Supplied as package of 10 (NDC 49281-121-65).

16.2 Storage and Handling

Store Fluzone High-Dose Quadrivalent 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.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information).

  • Inform the patient or caregiver that Fluzone High-Dose Quadrivalent contains killed viruses and cannot cause influenza.
  • Fluzone High-Dose Quadrivalent stimulates the immune system to produce antibodies that help protect against influenza.
  • Instruct that annual influenza vaccination is recommended.
  • Instruct vaccine recipients and caregivers to report adverse reactions to their healthcare provider and/or to Vaccine Adverse Event Reporting System (VAERS).
  • Give the Vaccine Information Statements to recipients or caregivers, which are required by the National Childhood Vaccine Injury Act of 1986 prior to each immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).

Fluzone is a registered trademark of Sanofi Pasteur Inc.

Manufactured by:
Sanofi Pasteur Inc.
Swiftwater, PA 18370 USA

Patient Information Sheet
Fluzone® High-Dose Quadrivalent Influenza Vaccine

Please read this information sheet before getting Fluzone High-Dose Quadrivalent 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 Fluzone High-Dose Quadrivalent vaccine?

Fluzone High-Dose Quadrivalent is a vaccine that helps protect against influenza illness (flu).

Fluzone High-Dose Quadrivalent vaccine is for people 65 years of age and older.

Vaccination with Fluzone High-Dose Quadrivalent vaccine may not protect all people who receive the vaccine.

Who should not get Fluzone High-Dose Quadrivalent vaccine?

You should not get Fluzone High-Dose Quadrivalent vaccine if you:

  • ever had a severe allergic reaction to eggs or egg products.
  • ever had a severe allergic reaction after getting any flu vaccine.
  • are younger than 65 years of age.

Tell your healthcare provider if you have or have had:

  • Guillain-Barré syndrome (severe muscle weakness) after getting a flu vaccine.
  • problems with your immune system as the immune response may be diminished.

How is Fluzone High-Dose Quadrivalent vaccine given?

Fluzone High-Dose Quadrivalent vaccine is a shot given into the muscle of the arm.

What are the possible side effects of Fluzone High-Dose Quadrivalent vaccine?

The most common side effects of Fluzone High-Dose Quadrivalent vaccine are:

  • pain, redness, and swelling where you got the shot
  • muscle ache
  • tiredness
  • headache

These are not all of the possible side effects of Fluzone High-Dose Quadrivalent 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 https://vaers.hhs.gov.

Why should I get Fluzone High-Dose Quadrivalent vaccine instead of a standard-dose quadrivalent influenza vaccine?

Among persons 65 years of age and older, Fluzone High-Dose Quadrivalent generated a similar immune response to Fluzone High-Dose and is expected to provide better protection against influenza compared to standard-dose quadrivalent influenza vaccines.

What are the ingredients in Fluzone High-Dose Quadrivalent vaccine?

Fluzone High-Dose Quadrivalent vaccine contains 4 killed flu virus strains. There is no live flu virus in Fluzone High-Dose Quadrivalent. Fluzone High-Dose Quadrivalent cannot cause the flu.

Inactive ingredients include formaldehyde and octylphenol ethoxylate.

Manufactured by: Sanofi Pasteur Inc.
Swiftwater, PA 18370 USA

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