Influenza immunization for patients ≥65yrs of age.

Clinical Trials:

Immunogenicity of Fluad Quadrivalent

  • The immunogenicity of Fluad Quadrivalent was evaluated in Study 1 (NCT02587221), a randomized, observer-blind, non-influenza comparator-controlled multicenter efficacy study. Patients 65 years of age and older received 1 dose of either Fluad Quadrivalent or a US-licensed non-influenza comparator vaccine (Boostrix).

  • Immunogenicity was evaluated 21 days after vaccination in a subgroup of subjects in a 4:1 ratio: Fluad Quadrivalent (N=1324) and non-influenza control vaccines (N=332). 

  • Immunogenicity endpoints measured 3 weeks after vaccination included percentage of subjects with HI titer ≥1:40 and percentage of subjects who achieved seroconversion. Success criteria required the lower bound of the 2-sided 95% CI for the proportion of subjects with an HI titer ≥1:40 to be ≥60% and for the lower bound of the 2-sided 95% CI for the proportion of subjects with seroconversion to be ≥30%.

  • The percentage of patients who achieved seroconversion in the Fluad Quadrivalent vs the non-influenza comparator vaccine are as followed, respectively:

    • A/H1N1: 78% vs 2.1%

    • A/H3N2: 84.6% vs 3.9%

    • B/Yamagata: 60.8% vs 3.6%

    • B/Victoria: 65.5% vs 2.1%

Adult Dosage:

<65yrs: not established. ≥65yrs: 0.5mL IM inj once in the deltoid; 1 dose per year.

Children Dosage:

Not established.

FLUAD QUADRIVALENT Contraindications:

Allergy to egg protein. Life-threatening reaction to any previous flu vaccine.

FLUAD QUADRIVALENT Warnings/Precautions:

Use current formulation only. Have appropriate medical treatment and supervision available. Guillain-Barré syndrome within 6 weeks of previous flu vaccine. Immunosuppressed. Syncope. May not protect all vaccine recipients against influenza disease. Pregnancy. Nursing mothers.


Influenza vaccine.


Concomitant with other vaccines: insufficient data (see full labeling). Immunosuppressants (eg, corticosteroids): may get suboptimal response.

Adverse Reactions:

Injection site pain, headache, fatigue.

Generic Drug Availability:


How Supplied:

Single-dose prefilled syringes (0.5mL)—10