Comparison of the Safety of Flublok® Versus Licensed IIV in Healthy, Medically Stable Adults ≥ 50 Years of Age

The Advisory Committee on Immunization Practices (ACIP) recommends that all people aged 6 months and older be immunized to prevent influenza. Currently the only approved influenza vaccine across the entire age group is inactivated influenza vaccine (IIV). A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Additional safety and, ultimately efficacy, data is needed to support use in adults ≥50 years of age, an important age group as adults ≥65 years of age are among those at increased risk of influenza complications.

Inclusion criteria

• Ambulatory adults aged 50 years and older
• Medically stable, as determined by medical history and targeted physical examination based on medical history, if appropriate
• Able to understand and comply with planned study procedures
• Provides written informed consent prior to initiation of any study procedure.

Exclusion criteria

• Known contraindication to either study vaccine (see product package inserts)
• Receipt of any other influenza or other vaccine within 30 days prior to enrollment in this study.
• Receipt of any new medication within 30 days prior to enrollment in this study
• Plans to participate in any investigation involving an investigational product during this study.
• Pre-existence of atopic dermatitis or any other cutaneous disorder that could complicate the evaluation of potential primary endpoints.
• Any clinical or social circumstance that in the opinion of the investigator could interfere with compliance with study procedures or interfere with the interpretation of clinical data.