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

NCT01825200 | Completed Phase 3 Results

• 1 other identifier: PSC11
• Study Type: interventional
• Target: 2,640
• Locations: 1 country
• Sites: 14

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.

Conditions

Influenza

Keywords

Influenza

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration

  30 Days

• Number of Participants With Local and Systemic Events Reported as a Measure of Safety

  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

  7 Days

Study Arms (2)

Flublok

ACTIVE COMPARATOR

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

Afluria

PLACEBO COMPARATOR

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

Interventions

Flublok BIOLOGICAL

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.

Flublok

Afluria BIOLOGICAL

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.

Afluria

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Protein Sciences Corporation: lead

Study Sites (14)

Genova Clinical Research

Tucson, Arizona, 85704-1152, United States

Location

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

Location

Meridian Clinical Research

Savannah, Georgia, 31406, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

Benchmark Research

Metairie, Louisiana, 70006, United States

Location

Maine Research Associates, LLC

Auburn, Maine, 04210, United States

Location

Meridian Clinical Research

Omaha, Nebraska, 68164, United States

Location

Clinical Research Center of Nevada, LLC

Las Vegas, Nevada, 89104, United States

Location

Regional Clinical Research

Binghamton, New York, 13901, United States

Location

Wake Research

Raleigh, North Carolina, 27612, United States

Location

Rapid Medical Research, Inc.

Cleveland, Ohio, 44122, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

Benchmark Research

Fort Worth, Texas, 76135, United States

Location

Benchmark Research

San Angelo, Texas, 76904, United States

Location

Related Publications (1)

• 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.

  PMID: 26529070 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Interventions

FluBlok; Afluria

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Limitations and Caveats

Rash, urticaria, swelling and edema were self-reported by subjects and most were not observed by investigators. Review by independent experts indicated that 42 of 52 subject-reported events did not represent Type 1 (IgE-mediated) hypersensitivity.

Results Point of Contact

• Title: Lisa M. Dunkle, M.D., Chief Medical Officer
• Organization: Protein Sciences Corporation

ldunkle@proteinsciences.com

203-599-6064

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: April 5, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: February 18, 2015
• Results First Posted: February 18, 2015

Record last verified: 2015-01

Locations

US (14)