Protective Efficacy of Flublok® Quadrivalent Versus Licensed Inactivated Influenza Vaccine in Adults ≥50 Years of Age

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02285998
• Other study ID #: PSC12
• Status: Completed
• Phase: Phase 3
• First received: October 27, 2014
• Last updated: September 26, 2017
• Start date: October 2014
• Est. completion date: May 2015

Study information

• Verified date: September 2017
• Source: Protein Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9003
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Flublok Quadrivalent Influenza Vaccine
Intramuscular injection of vaccine
• Inactivated Influenza Vaccine
Intramuscular injection of vaccine

Locations

Country	Name	City	State
United States	Benchmark Reseach	Austin	Texas
United States	Meridian Research	Bellevue	Nebraska
United States	Rapid Medical Research, Inc.	Cleveland	Ohio
United States	Lynn Institute of the Rockies	Colorado Springs	Colorado
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	Meridian Research	Dakota Dunes	South Dakota
United States	Avail Clinical Research	DeLand	Florida
United States	Regional Clinical Research, Inc.	Endwell	New York
United States	Benchmark Research - Fort Worth	Fort Worth	Texas
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Westside Center for Clinical Research	Jacksonville	Florida
United States	Center for Pharmaceutical Research	Kansas City	Missouri
United States	Clinical Research Consortium-Nevada	Las Vegas	Nevada
United States	Central Kentucky Research Associates	Lexington	Kentucky
United States	Baptist Health Center for Clinical Research	Little Rock	Arkansas
United States	ACR - Boise	Meridian	Idaho
United States	Benchmarch Research - New Orleans	Metairie	Louisiana
United States	ActivMed Practices & Research	Methuen	Massachusetts
United States	Clinical Research Consulting	Milford	Connecticut
United States	Coastal Clinical Research	Mobile	Alabama
United States	Clinical Research Associates	Nashville	Tennessee
United States	ActivMed Practices & Research	Newington	New Hampshire
United States	Clinical Research Associates of Tidewater	Norfolk	Virginia
United States	Meridian Research	Norfolk	Nebraska
United States	Lynn Institute of Norman	Norman	Oklahoma
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Meridian Clinical Research	Omaha	Nebraska
United States	Progressive Medical Research	Port Orange	Florida
United States	Wake Research	Raleigh	North Carolina
United States	Northern California Clinical Research Center	Redding	California
United States	Rochester Clinical Research	Rochester	New York
United States	Benchmark Research - Sacramento	Sacramento	California
United States	Jean Brown Research	Salt Lake City	Utah
United States	Benchmark Research - San Angelo	San Angelo	Texas
United States	Benchmark Research - San Francisco	San Francisco	California
United States	Meridian Research	Savannah	Georgia
United States	Clinical Research Consortium Arizona	Tempe	Arizona
United States	Heartland Research Associates, LLC	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Protein Sciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With rtPCR-confirmed Influenza-Like Illness	rtPCR-confirmed, protocol-defined Influenza-Like Illness (ILI) caused by any influenza strain that begins at least 14 days post-vaccination	14 days post vaccination through and up to 32 weeks post vaccination
Secondary	Number of Participants With Culture-confirmed Influenza-Like Illness	Culture-confirmed protocol-defined Influenza-Like Illness (ILI) that begins at least 14 days post-vaccination caused by an influenza strain (identified from the same clinical sample) antigenically matched to those strains represented in the study vaccines.; Protocol-defined ILI is defined as at least one of the following respiratory symptoms accompanied by at least one of the following systemic symptoms: Respiratory symptoms: sore throat, cough, sputm production, wheezing, difficulty breathing Systemic symptoms: fever, chills (shivering), tiredness (fatigue), headache, myalgia (muscle ache)	14 days post vaccination through and up to 32 weeks post vaccination
Secondary	Number of Participants With Culture-confirmed CDC-defined Influenza-Like Illness	Culture-confirmed CDC-defined Influenza-Like Illness (ILI) that begins at least 14 days post-vaccination caused by an influenza strain (identified from the same clinical sample) antigenically matched to those in the study vaccines.; CDC-defined ILI is defined as body temperature =100°F accompanied by cough and/or sore throat.	14 days post vaccination through and up to 32 weeks post vaccination
Secondary	Number of Participants With rtPCR-confirmed CDC-defined Influenza-Like Illness	rtPCR-confirmed CDC-defined ILI that begins at least 14 days post-vaccination caused by any influenza strain.	14 days post vaccination through and up to 32 weeks post vaccination
Secondary	Percentage of Participants With Seroconversion	Seroconversion rates (SCR) for all four antigens in a preselected subset of subjects.	Days 0 through 28
Secondary	Number of Participants With Local Injection Site Reactogenicity	Solicited events of injection site reactogenicity reported during Day 0-7.	Days 0 through 7
Secondary	Number of Participants With Unsolicited Adverse Events	Unsolicited adverse events reported in the 28 days following vaccine administration.	Days 0 through 28
Secondary	Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs)	Serious adverse events (SAEs) and medically-attended adverse events (MAEs) occurring during the period of follow-up through the influenza season (at least 6 months post-vaccination).; A MAE is an event that prompts an unplanned visit to a medical professional for diagnosis and/or treatment.	Day 0 through and up to 32 weeks post vaccination
Secondary	Measure of Post-vaccination HAI GMTs	GMT titers for all four antigens in a preselected subset of subjects.	Days 0 through 28
Secondary	Number of Participants With Systemic Reactogenicity	Solicited events of systemic reactogenicity reported during Day 0-7.	Days 0 through 7

External Links

•   Flublok Influenza Vaccine