Clinical trial NCT02285998: Protective Efficacy of Flublok® Quadrivalent Versus Licensed Inactivated Influenza Vaccine in Adults ≥50 Years of Age
Official title: Comparison of the Protective Efficacy of Flublok® Quadrivalent Versus Licensed Inactivated Influenza Vaccine (IIV4) 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: 2014-11-07
Enrollment: 9003
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 goal of this study is to establish that Flublok Quadrivalent is non-inferior to fully licensed (traditional approval status) quadrivalent inactivated influenza vaccine (IIV4) in protecting against laboratory-confirmed clinical influenza disease in the ≥50 year age population.

Detailed description: The goal of this study is to establish that Flublok Quadrivalent is non-inferior to fully licensed (traditional approval status) quadrivalent inactivated influenza vaccine (IIV4) in protecting against laboratory-confirmed clinical influenza disease in the ≥50 year age population. Real-time Polymerase Chain Reaction (rtPCR) will be used to confirm influenza infection and to type the strains involved, as molecular methodologies have been demonstrated to be more sensitive than other more traditional methodologies, e.g. culture. For rtPCR-positive clinical samples, reserved aliquots will be processed for culture, so that antigenic similarity to the HA present in study vaccines can be tested.

In various clinical studies the investigators demonstrated that the immune response against the influenza A viruses is improved as a result of the higher hemagglutinin content. Furthermore, influenza virus disease and hospitalization associated with influenza-related illness in older adults (\> 50 years) was considerably reduced (90%) following vaccination with TIV, even though the circulating influenza A strain was antigenically dissimilar to that in the vaccine. However, more recently Skowronski et al. reported that the low influenza vaccine effectiveness in 2012-2013 was not associated with antigenic drift but was instead related to mutations in the egg-adapted H3N2 vaccine strain. Flublok manufactured using recombinant technology does not contain the mutations responsible for the reported lower effectiveness and may thus offer improved protection when mutations such as those described are induced in the process of adapting the influenza virus to growth in eggs.

Eligibility criteria: Inclusion Criteria:

1. Ambulatory adults aged 50 and older.
2. Medically stable, as determined by medical history and targeted physical examination. "Medically stable" is defined as no change in diagnoses or chronic medications (dose or class) for medical reasons in the 3 months prior to study.
3. Absence of underlying conditions that make participation in the study contrary to the subject's best interest.
4. Able to understand and comply with planned study procedures.
5. 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 vaccine within 180 days prior to enrollment in this study.
3. Underlying disease or ongoing therapy that might cause immunocompromise, e.g. cytotoxic agents or supraphysiologic doses of corticosteroids, such that response to vaccination might be sub-optimal.

Primary outcomes:
measure: Number of Participants With rtPCR-confirmed Influenza-Like Illness
timeFrame: 14 days post vaccination through and up to 32 weeks post vaccination
Secondary outcomes:
measure: Number of Participants With Culture-confirmed Influenza-Like Illness
timeFrame: 14 days post vaccination through and up to 32 weeks post vaccination
measure: Number of Participants With Culture-confirmed CDC-defined Influenza-Like Illness
timeFrame: 14 days post vaccination through and up to 32 weeks post vaccination
measure: Number of Participants With rtPCR-confirmed CDC-defined Influenza-Like Illness
timeFrame: 14 days post vaccination through and up to 32 weeks post vaccination
measure: Percentage of Participants With Seroconversion
timeFrame: Days 0 through 28
measure: Number of Participants With Local Injection Site Reactogenicity
timeFrame: Days 0 through 7
measure: Number of Participants With Unsolicited Adverse Events
timeFrame: Days 0 through 28
measure: Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs)
timeFrame: Day 0 through and up to 32 weeks post vaccination
measure: Measure of Post-vaccination HAI GMTs
timeFrame: Days 0 through 28
measure: Number of Participants With Systemic Reactogenicity
timeFrame: Days 0 through 7
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research
state: Alabama
city: Tempe
country: United States
facility: Clinical Research Consortium Arizona
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
city: Redding
country: United States
facility: Northern California Clinical Research Center
state: California
city: Sacramento
country: United States
facility: Benchmark Research - Sacramento
state: California
city: San Francisco
country: United States
facility: Benchmark Research - San Francisco
state: California
city: Colorado Springs
country: United States
facility: Lynn Institute of the Rockies
state: Colorado
city: Milford
country: United States
facility: Clinical Research Consulting
state: Connecticut
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Westside Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Savannah
country: United States
facility: Meridian Research
state: Georgia
city: Meridian
country: United States
facility: ACR - Boise
state: Idaho
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Lexington
country: United States
facility: Central Kentucky Research Associates
state: Kentucky
city: Metairie
country: United States
facility: Benchmarch Research - New Orleans
state: Louisiana
city: Methuen
country: United States
facility: ActivMed Practices & Research
state: Massachusetts
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research
state: Missouri
city: Bellevue
country: United States
facility: Meridian Research
state: Nebraska
city: Norfolk
country: United States
facility: Meridian Research
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Consortium-Nevada
state: Nevada
city: Newington
country: United States
facility: ActivMed Practices & Research
state: New Hampshire
city: Endwell
country: United States
facility: Regional Clinical Research, Inc.
state: New York
city: Rochester
country: United States
facility: Rochester 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: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Dakota Dunes
country: United States
facility: Meridian Research
state: South Dakota
city: Nashville
country: United States
facility: Clinical Research Associates
state: Tennessee
city: Austin
country: United States
facility: Benchmark Reseach
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research - Fort Worth
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research - San Angelo
state: Texas
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater
state: Virginia
Study officials:
References:
citation: Dunkle LM, Izikson R, Patriarca P, Goldenthal KL, Muse D, Callahan J, Cox MMJ; PSC12 Study Team. Efficacy of Recombinant Influenza Vaccine in Adults 50 Years of Age or Older. N Engl J Med. 2017 Jun 22;376(25):2427-2436. doi: 10.1056/NEJMoa1608862.