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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Flublok
Afluria
Sponsored by
Protein Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Genova Clinical Research
  • Clinical Research of South Florida
  • Meridian Clinical Research
  • Heartland Research Associates, LLC
  • Benchmark Research
  • Maine Research Associates, LLC
  • Meridian Clinical Research
  • Clinical Research Center of Nevada, LLC
  • Regional Clinical Research
  • Wake Research
  • Rapid Medical Research, Inc.
  • Research Across America
  • Benchmark Research
  • Benchmark Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Flublok

Afluria

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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

Full Information

First Posted
March 11, 2013
Last Updated
January 29, 2015
Sponsor
Protein Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01825200
Brief Title
Comparison of the Safety of Flublok® Versus Licensed IIV in Healthy, Medically Stable Adults ≥ 50 Years of Age
Official Title
Comparison of the Safety of Flublok® Versus Licensed Inactivated Influenza Vaccine in Healthy, Medically Stable Adults ≥ 50 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Protein Sciences Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2640 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flublok
Arm Type
Active Comparator
Arm Description
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
Arm Title
Afluria
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Flublok
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Afluria
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Common Hypersensitivity Reactions as Measure of Safety
Description
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.
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration
Description
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
Time Frame
30 Days
Title
Number of Participants With Local and Systemic Events Reported as a Measure of Safety
Description
Number of solicited local and systemic events of reactogenicity reported with the help of a memory aid during the seven days following vaccine administration.
Time Frame
7 Days
Title
Subjects With at Least One Hypersensitivity Event Reported on Day 0 and Days 0-7 Following Vaccine Administration as a Measure of Safety
Description
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
Time Frame
7 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon Essink, MD
Organizational Affiliation
Meridian Clinical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Bradley, MD
Organizational Affiliation
Meridian Clinical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Seger, MD
Organizational Affiliation
Benchmark Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Darrell Herrington, DO
Organizational Affiliation
Benchmark Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
George Bauer, MD
Organizational Affiliation
Benchmark Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frank Eder, MD
Organizational Affiliation
Regional Clinical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Treva Tyson, MD
Organizational Affiliation
Wake Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bob Weiss, MD
Organizational Affiliation
Maine Research Associates, LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey Rosen, MD
Organizational Affiliation
Clinical Research of South Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joe Blumenau, MD
Organizational Affiliation
Research Across America
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven Folkerth, MD
Organizational Affiliation
Clinical Research Center of Nevada, LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leah Schmidt, DO
Organizational Affiliation
Genova Clinical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Sheldon
Organizational Affiliation
Miami Research Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alan C. Wine, MD
Organizational Affiliation
Rapid Medical Research, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Terry Poling, MD
Organizational Affiliation
Heartland Research Associates, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Genova Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704-1152
Country
United States
Facility Name
Clinical Research of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Meridian Clinical Research
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Benchmark Research
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Maine Research Associates, LLC
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Meridian Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68164
Country
United States
Facility Name
Clinical Research Center of Nevada, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
Regional Clinical Research
City
Binghamton
State/Province
New York
ZIP/Postal Code
13901
Country
United States
Facility Name
Wake Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Rapid Medical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Benchmark Research
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
Benchmark Research
City
San Angelo
State/Province
Texas
ZIP/Postal Code
76904
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26529070
Citation
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.
Results Reference
derived
Links:
URL
http://proteinsciences.com
Description
Related Info

Learn more about this trial

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

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