Status:
COMPLETED
Comparison of the Safety of Flublok® Versus Licensed IIV in Healthy, Medically Stable Adults ≥ 50 Years of Age
Lead Sponsor:
Protein Sciences Corporation
Conditions:
Influenza
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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 I...
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 e...
Eligibility Criteria
Inclusion
- Ambulatory adults aged 50 years and older
- Medically stable, as determined by medical history and targeted physical examination based on medical history, if appropriate
- 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 or other vaccine within 30 days prior to enrollment in this study.
- Receipt of any new medication within 30 days prior to enrollment in this study
- Plans to participate in any investigation involving an investigational product during this study.
- Pre-existence of atopic dermatitis or any other cutaneous disorder that could complicate the evaluation of potential primary endpoints.
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
2640 Patients enrolled
Trial Details
Trial ID
NCT01825200
Start Date
March 1 2013
End Date
May 1 2013
Last Update
February 18 2015
Active Locations (14)
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1
Genova Clinical Research
Tucson, Arizona, United States, 85704-1152
2
Clinical Research of South Florida
Coral Gables, Florida, United States, 33134
3
Meridian Clinical Research
Savannah, Georgia, United States, 31406
4
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67207