NCT01825200

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,640 (actual)
• Sponsor: Protein Sciences Corporation · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The hypothesis for this trial is that the incidence of a pre-defined composite of common systemic hypersensitivity adverse events for Flublok recipients is non-inferior to that reported for licensed IIV recipients. Another hypothesis is that the safety and reactogenicity of Flublok is clinically acceptable, i.e. consistent with the overall safety profiles previously observed with Flublok and with the licensed comparator.

Detailed description

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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Flublok	A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions.
BIOLOGICAL	Afluria	Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs.

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2013-04-05
• Last updated: 2015-02-18
• Results posted: 2015-02-18

Locations

14 sites across 1 country: United States