Protective Efficacy of Flublok® Quadrivalent Versus Licensed Inactivated Influenza Vaccine in Adults ≥50 Years of Age
Comparison of the Protective Efficacy of Flublok® Quadrivalent Versus Licensed Inactivated Influenza Vaccine (IIV4) in Healthy, Medically Stable Adults ≥50 Years of Age
1 other identifier
interventional
9,003
1 country
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2014
Shorter than P25 for phase_3
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 27, 2014
CompletedFirst Posted
Study publicly available on registry
November 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
October 4, 2016
CompletedOctober 27, 2017
September 1, 2017
7 months
October 27, 2014
August 3, 2016
September 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Number of Participants With Culture-confirmed Influenza-Like Illness
14 days post vaccination through and up to 32 weeks post vaccination
Number of Participants With Culture-confirmed CDC-defined Influenza-Like Illness
14 days post vaccination through and up to 32 weeks post vaccination
Number of Participants With rtPCR-confirmed CDC-defined Influenza-Like Illness
14 days post vaccination through and up to 32 weeks post vaccination
Percentage of Participants With Seroconversion
Days 0 through 28
Number of Participants With Local Injection Site Reactogenicity
Days 0 through 7
- +4 more secondary outcomes
Study Arms (2)
Flublok Quadrivalent Influenza Vaccine
EXPERIMENTALIntramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Inactivated Influenza Vaccine
ACTIVE COMPARATORIntramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Interventions
Intramuscular injection of vaccine
Intramuscular injection of vaccine
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Coastal Clinical Research
Mobile, Alabama, 36608, United States
Clinical Research Consortium Arizona
Tempe, Arizona, 85283, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205, United States
Northern California Clinical Research Center
Redding, California, 96001, United States
Benchmark Research - Sacramento
Sacramento, California, 95816, United States
Benchmark Research - San Francisco
San Francisco, California, 94102, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80907, United States
Clinical Research Consulting
Milford, Connecticut, 06460, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Avail Clinical Research
DeLand, Florida, 32720, United States
Westside Center for Clinical Research
Jacksonville, Florida, 32205, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Meridian Research
Savannah, Georgia, 31406, United States
ACR - Boise
Meridian, Idaho, 83642, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
Central Kentucky Research Associates
Lexington, Kentucky, 40509, United States
Benchmarch Research - New Orleans
Metairie, Louisiana, 70006, United States
ActivMed Practices & Research
Methuen, Massachusetts, 01844, United States
Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
Meridian Research
Bellevue, Nebraska, 68005, United States
Meridian Research
Norfolk, Nebraska, 68701, United States
Meridian Clinical Research
Omaha, Nebraska, 68164, United States
Clinical Research Consortium-Nevada
Las Vegas, Nevada, 89119, United States
ActivMed Practices & Research
Newington, New Hampshire, 03801, United States
Regional Clinical Research, Inc.
Endwell, New York, 13760, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
Wake Research
Raleigh, North Carolina, 27612, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122, United States
Lynn Institute of Norman
Norman, Oklahoma, 73069, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Meridian Research
Dakota Dunes, South Dakota, 57049, United States
Clinical Research Associates
Nashville, Tennessee, 37203, United States
Benchmark Reseach
Austin, Texas, 78705, United States
Benchmark Research - Fort Worth
Fort Worth, Texas, 76135, United States
Benchmark Research - San Angelo
San Angelo, Texas, 76904, United States
Jean Brown Research
Salt Lake City, Utah, 84124, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507, United States
Related Publications (1)
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.
PMID: 28636855DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lisa M. Dunkle, M.D., Chief Medical Officer
- Organization
- Protein Sciences Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2014
First Posted
November 7, 2014
Study Start
October 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
October 27, 2017
Results First Posted
October 4, 2016
Record last verified: 2017-09