Safety and Immunogenicity of Flublok Quadrivalent vs IIV4 in Adults 18-49 Years of Age

Completed · Phase 3

Conditions studied: Influenza

In brief

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 samples for Hemagglutinin Inhibition titers will be determined pre- and 28 days post-vaccination. Subjects will be followed for 6 months after vaccination for serious and/or medically-attended adverse events.

Key facts

Study ID

NCT02290509

Run by

Protein Sciences Corporation

People needed

1350

Starts

2014-10-01

Expected to finish

2015-05-01

Last updated by the study team

2016-10-27

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Benchmark Research - Sacramento — Sacramento, California, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• Meridian Clinical Research — Savannah, Georgia, United States
• Heartland Research Associates, LLC — Wichita, Kansas, United States
• Benchmark Research — Metairie, Louisiana, United States
• Meridian Research — Bellevue, Nebraska, United States
• Meridian Clinical Research — Omaha, Nebraska, United States
• Meridian Research — Dakota Dunes, South Dakota, United States
• Benchmark Reseach — Austin, Texas, United States
• Benchmark Research - Fort Worth — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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