Phase 3 Safety and Immunogenicity Study of aQIV in Elderly Adults



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:65 - Any
Updated:11/28/2018
Start Date:October 17, 2017
End Date:May 17, 2018

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A Phase 3, Randomized, Double-Blind, Controlled, Multicenter, Clinical Study to Evaluate Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Subunit Influenza Vaccine in Comparison With an MF59-Adjuvanted Trivalent Subunit Influenza Vaccine and an MF59-Adjuvanted Trivalent Subunit Influenza Vaccine Containing the Alternate B Strain, in Adults Aged 65 Years and Above

This phase 3 study is a randomized, double-blinded, comparator controlled, parallel-group,
multicenter study of aQIV versus the US-licensed 2017-2018 adjuvanted trivalent influenza
vaccine (aTIV-1, Fluad), and versus an adjuvanted trivalent influenza vaccine (aTIV-2),
containing the alternate B strain.


Inclusion Criteria:

- Males and females ≥ 65 years old who are healthy or have co-morbidities

- Individuals who or whose legal representative(s) have voluntarily given written
consent after the nature of the study has been explained according to local regulatory
requirements, prior to study entry

- Ability to attend all scheduled visits and to comply with study procedures including
Diary card completion and follow-up

Exclusion Criteria:

- History of behavioral or cognitive impairment or psychiatric condition

- Hypersensitivity, including allergy, to any component of vaccines, medicinal products
or medical equipment whose use is foreseen in this study

- Abnormal function of the immune system

- Receipt of any influenza vaccine within 6 months prior to enrollment in this study, or
plan to receive influenza vaccine prior to the Day 22 blood collection

- Any other clinical condition that, in the opinion of the Investigator, might interfere
with the results of the study or pose additional risk to the subject due to
participation in the study

Additional eligibility criteria may be discussed by contacting the site.
We found this trial at
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San Angelo, Texas 76904
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1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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Binghamton, New York 13901
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Charleston, South Carolina 29407
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Cleveland, Ohio 44122
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370 Minorca Avenue
Coral Gables, Florida 33134
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Fort Worth, Texas 76135
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Kansas City, Missouri 64114
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Knoxville, Tennessee 37920
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Lenexa, Kansas 66219
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Meridian, Idaho 83642
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Mobile, Alabama 36608
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Mobile, AL
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1709 South Rock Road
Newton, Kansas 67114
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Newton, KS
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Omaha, Nebraska 68134
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Omaha, NE
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3652 Eureka Way
Redding, California 96001
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Redding, CA
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Saint Louis, Missouri 63141
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6602 Waters Avenue
Savannah, Georgia 31406
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Savannah, GA
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Tomball, Texas 77375
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West Jordan, Utah 84088
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1709 South Rock Road
Wichita, Kansas 67207
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