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

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.

Conditions

• Influenza

Interventions

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.

Sponsors & Collaborators

• Protein Sciences Corporation

  lead INDUSTRY

Principal Investigators

• Brandon Essink, MD · Meridian Clinical Research

• Paul Bradley, MD · Meridian Clinical Research

• William Seger, MD · Benchmark Research

• Darrell Herrington, DO · Benchmark Research

• George Bauer, MD · Benchmark Research

• Frank Eder, MD · Regional Clinical Research

• Treva Tyson, MD · Wake Research

• Bob Weiss, MD · Maine Research Associates, LLC

• Jeffrey Rosen, MD · Clinical Research of South Florida

• Joe Blumenau, MD · Research Across America

• Steven Folkerth, MD · Clinical Research Center of Nevada, LLC

• Leah Schmidt, DO · Genova Clinical Research

• Eric Sheldon · Miami Research Associates

• Alan C. Wine, MD · Rapid Medical Research, Inc.

• Terry Poling, MD · Heartland Research Associates, LLC

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-03-31

Primary Completion

2013-05-31

Completion

2013-05-31

Countries

• United States

Study Locations