Status:
COMPLETED
Protective Efficacy of Flublok® Quadrivalent Versus Licensed Inactivated Influenza Vaccine in Adults ≥50 Years of Age
Lead Sponsor:
Protein Sciences Corporation
Conditions:
Influenza
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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...
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...
Eligibility Criteria
Inclusion
- Ambulatory adults aged 50 and older.
- 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.
- Absence of underlying conditions that make participation in the study contrary to the subject's best interest.
- Able to understand and comply with planned study procedures.
- Provides written informed consent prior to initiation of any study procedure.
Exclusion
- Known contraindication to either study vaccine (see product package inserts)
- Receipt of any other influenza vaccine within 180 days prior to enrollment in this study.
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
9003 Patients enrolled
Trial Details
Trial ID
NCT02285998
Start Date
October 1 2014
End Date
May 1 2015
Last Update
October 27 2017
Active Locations (38)
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1
Coastal Clinical Research
Mobile, Alabama, United States, 36608
2
Clinical Research Consortium Arizona
Tempe, Arizona, United States, 85283
3
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States, 72205
4
Northern California Clinical Research Center
Redding, California, United States, 96001