FLUAD QUADRIVALENT

Generic Name & Formulations:

Quadrivalent, inactivated, adjuvanted (MF59C.1) influenza vaccine (virus types A and B); contains a total of at least 60mcg of hemagglutinin per 0.5mL dose; formulation changes annually; emulsion for IM inj; may contain trace amounts of neomycin, kanamycin, hydrocortisone, egg protein, formaldehyde or CTAB; preservative-free.

Company:

Vaccines

Vaccines:

Indications for: FLUAD QUADRIVALENT

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.