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

• ClinicalTrials.gov Identifier: NCT01825200
• Recruitment Status: Completed
• First Posted: April 5, 2013
• Results First Posted: February 18, 2015
• Last Update Posted: February 18, 2015
• Sponsor: Protein Sciences Corporation
• Information provided by (Responsible Party): Protein Sciences Corporation

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.

Condition or disease	Intervention/treatment	Phase
Influenza	Biological: Flublok; Biological: Afluria	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2640 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Comparison of the Safety of Flublok® Versus Licensed Inactivated Influenza Vaccine in Healthy, Medically Stable Adults ≥ 50 Years of Age
• Study Start Date: March 2013
• Actual Primary Completion Date: May 2013
• Actual Study Completion Date: May 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Common Hypersensitivity Reactions as Measure of Safety [ Time Frame: 30 Days ]
   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 :

1. Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration [ Time Frame: 30 Days ]
   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
2. Number of Participants With Local and Systemic Events Reported as a Measure of Safety [ Time Frame: 7 Days ]
   Number of solicited local and systemic events of reactogenicity reported with the help of a memory aid during the seven days following vaccine administration.
3. Subjects With at Least One Hypersensitivity Event Reported on Day 0 and Days 0-7 Following Vaccine Administration as a Measure of Safety [ Time Frame: 7 Days ]
   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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Arizona

Genova Clinical Research

Tucson, Arizona, United States, 85704-1152

United States, Florida

Clinical Research of South Florida

Coral Gables, Florida, United States, 33134

United States, Georgia

Meridian Clinical Research

Savannah, Georgia, United States, 31406

United States, Kansas

Heartland Research Associates, LLC

Wichita, Kansas, United States, 67207

United States, Louisiana

Benchmark Research

Metairie, Louisiana, United States, 70006

United States, Maine

Maine Research Associates, LLC

Auburn, Maine, United States, 04210

United States, Nebraska

Meridian Clinical Research

Omaha, Nebraska, United States, 68164

United States, Nevada

Clinical Research Center of Nevada, LLC

Las Vegas, Nevada, United States, 89104

United States, New York

Regional Clinical Research

Binghamton, New York, United States, 13901

United States, North Carolina

Wake Research

Raleigh, North Carolina, United States, 27612

United States, Ohio

Rapid Medical Research, Inc.

Cleveland, Ohio, United States, 44122

United States, Texas

Research Across America

Dallas, Texas, United States, 75234

Benchmark Research

Fort Worth, Texas, United States, 76135

Benchmark Research

San Angelo, Texas, United States, 76904

Sponsors and Collaborators

Protein Sciences Corporation

Investigators

• 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: Joe Blumenau, MD; Research Across America
• 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

More Information

Additional Information:

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Izikson R, Leffell DJ, Bock SA, Patriarca PA, Post P, Dunkle LM, Cox MM. Randomized comparison of the safety of Flublok(®) 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.

• Responsible Party: Protein Sciences Corporation
• ClinicalTrials.gov Identifier: NCT01825200
• Other Study ID Numbers: PSC11
• First Posted: April 5, 2013
• Results First Posted: February 18, 2015
• Last Update Posted: February 18, 2015
• Last Verified: January 2015

Keywords provided by Protein Sciences Corporation:

Influenza

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases