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

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Flublok; Biological: Afluria

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.

• Study Type: Interventional
• Enrollment (Actual): 2640
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85704-1152
      • Genova Clinical Research
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Clinical Research of South Florida
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Meridian Clinical Research
  • Kansas
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates, LLC
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Benchmark Research
  • Maine
    • Auburn, Maine, United States, 04210
      • Maine Research Associates, LLC
  • Nebraska
    • Omaha, Nebraska, United States, 68164
      • Meridian Clinical Research
  • Nevada
    • Las Vegas, Nevada, United States, 89104
      • Clinical Research Center of Nevada, LLC
  • New York
    • Binghamton, New York, United States, 13901
      • Regional Clinical Research
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Wake Research
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Rapid Medical Research, Inc.
  • Texas
    • Dallas, Texas, United States, 75234
      • Research Across America
    • Fort Worth, Texas, United States, 76135
      • Benchmark Research
    • San Angelo, Texas, United States, 76904
      • Benchmark Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Known contraindication to either study vaccine (see product package inserts)
2. Receipt of any other influenza or other vaccine within 30 days prior to enrollment in this study.
3. Receipt of any new medication within 30 days prior to enrollment in this study
4. Plans to participate in any investigation involving an investigational product during this study.
5. Pre-existence of atopic dermatitis or any other cutaneous disorder that could complicate the evaluation of potential primary endpoints.
6. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Flublok; Flublok containing 3x45µg (135µg total) of recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5 mL	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.
Placebo Comparator: Afluria; Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5 mL	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Common Hypersensitivity Reactions as Measure of Safety	Number of participants who experience a pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or edema through Day 30 post-vaccine administration.	30 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration	Subjects with at least one serious adverse event and subjects with at least one medically-attended unsolicited adverse event occurring during the 30 days following vaccine administration	30 Days
Number of Participants With Local and Systemic Events Reported as a Measure of Safety	Number of solicited local and systemic events of reactogenicity reported with the help of a memory aid during the seven days following vaccine administration.	7 Days
Subjects With at Least One Hypersensitivity Event Reported on Day 0 and Days 0-7 Following Vaccine Administration as a Measure of Safety	Subjects with at least one pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or non-dependent edema on Day 0 and for Days 0 to 7 following vaccine administration	7 Days

Collaborators and Investigators

• Sponsor: Protein Sciences Corporation
• Investigators: Principal Investigator: Joe Blumenau, MD, Research Across America; Principal Investigator: Brandon Essink, MD, Meridian Clinical Research; Principal Investigator: Paul Bradley, MD, Meridian Clinical Research; Principal Investigator: William Seger, MD, Benchmark Research; Principal Investigator: Darrell Herrington, DO, Benchmark Research; Principal Investigator: George Bauer, MD, Benchmark Research; Principal Investigator: Frank Eder, MD, Regional Clinical Research; Principal Investigator: Treva Tyson, MD, Wake Research; Principal Investigator: Bob Weiss, MD, Maine Research Associates, LLC; Principal Investigator: Jeffrey Rosen, MD, Clinical Research of South Florida; Principal Investigator: Steven Folkerth, MD, Clinical Research Center of Nevada, LLC; Principal Investigator: Leah Schmidt, DO, Genova Clinical Research; Principal Investigator: Eric Sheldon, Miami Research Associates; Principal Investigator: Alan C. Wine, MD, Rapid Medical Research, Inc.; Principal Investigator: Terry Poling, MD, Heartland Research Associates, LLC

Publications and helpful links

General Publications

• Izikson R, Leffell DJ, Bock SA, Patriarca PA, Post P, Dunkle LM, Cox MM. Randomized comparison of the safety of Flublok((R)) versus licensed inactivated influenza vaccine in healthy, medically stable adults >/= 50 years of age. Vaccine. 2015 Nov 27;33(48):6622-8. doi: 10.1016/j.vaccine.2015.10.097. Epub 2015 Nov 1.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: March 11, 2013
• First Submitted That Met QC Criteria: April 2, 2013
• First Posted (Estimate): April 5, 2013

Study Record Updates

• Last Update Posted (Estimate): February 18, 2015
• Last Update Submitted That Met QC Criteria: January 29, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Influenza
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: PSC11