Clinical trial NCT01825200: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
Lead sponsor: Protein Sciences Corporation
Sponsor class: INDUSTRY
First posted: 2013-04-05
Enrollment: 2640
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Common Hypersensitivity Reactions as Measure of Safety
timeFrame: 30 Days
Secondary outcomes:
measure: Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration
timeFrame: 30 Days
measure: Number of Participants With Local and Systemic Events Reported as a Measure of Safety
timeFrame: 7 Days
measure: Subjects With at Least One Hypersensitivity Event Reported on Day 0 and Days 0-7 Following Vaccine Administration as a Measure of Safety
timeFrame: 7 Days
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Genova Clinical Research
state: Arizona
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Metairie
country: United States
facility: Benchmark Research
state: Louisiana
city: Auburn
country: United States
facility: Maine Research Associates, LLC
state: Maine
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada, LLC
state: Nevada
city: Binghamton
country: United States
facility: Regional Clinical Research
state: New York
city: Raleigh
country: United States
facility: Wake Research
state: North Carolina
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research
state: Texas
Study officials:
affiliation: Meridian Clinical Research
name: Brandon Essink, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Meridian Clinical Research
name: Paul Bradley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Benchmark Research
name: William Seger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Benchmark Research
name: Darrell Herrington, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Benchmark Research
name: George Bauer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Regional Clinical Research
name: Frank Eder, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Research
name: Treva Tyson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maine Research Associates, LLC
name: Bob Weiss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research of South Florida
name: Jeffrey Rosen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Across America
name: Joe Blumenau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Center of Nevada, LLC
name: Steven Folkerth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Genova Clinical Research
name: Leah Schmidt, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Miami Research Associates
name: Eric Sheldon
role: PRINCIPAL_INVESTIGATOR
affiliation: Rapid Medical Research, Inc.
name: Alan C. Wine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heartland Research Associates, LLC
name: Terry Poling, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.