Status:
COMPLETED
Safety and Immunogenicity of Flublok Quadrivalent vs IIV4 in Adults 18-49 Years of Age
Lead Sponsor:
Protein Sciences Corporation
Collaborating Sponsors:
Syneos Health
Department of Health and Human Services
Conditions:
Influenza
Eligibility:
All Genders
18-49 years
Phase:
PHASE3
Brief Summary
Randomized, double-blind trial of safety and immunogenicity of Flublok Quadrivalent versus Inactivated Influenza Vaccine (IIV4) in 1350 healthy, medically stable adults 18-49 years of age. Serum sampl...
Detailed Description
As the spectrum of influenza vaccines rapidly evolves to quadrivalent formulations with the intention of offering broader protection to include both lineages of influenza B strains, it is appropriate ...
Eligibility Criteria
Inclusion
- Ambulatory, in good health or medically stable
- Able to understand and comply with planned study procedures
- Provide written informed consent
- Negative urine pregnancy test within 24 hours prior to vaccination (women of child-bearing potential)
Exclusion
- Prior serious or severe reaction to influenza vaccine
- Known contraindication to either study vaccine
- Receipt of any other influenza vaccine within 180 days prior to enrollment
- Plan to receive another licensed influenza or other vaccine during the duration of this study
- Receipt of any significant new diagnosis, medication (licensed or investigational), or licensed vaccine within 30 days prior to enrollment in this study
- Underlying disease or therapeutic intervention that might adversely affect the immune response
- Plans to participate in any investigation involving an investigational product during this study.
- Pregnant, lactating or planning to become pregnant within 30 days of study vaccine.
- Any clinical or social circumstance that in the opinion of the investigator could interfere with compliance with study procedures or interfere with the interpretation
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
1350 Patients enrolled
Trial Details
Trial ID
NCT02290509
Start Date
October 1 2014
End Date
May 1 2015
Last Update
October 27 2016
Active Locations (10)
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1
Benchmark Research - Sacramento
Sacramento, California, United States, 95816
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