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
20
sites
Omaha, Nebraska 68134
1360
mi
from 98109
Omaha, NE
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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...
980
mi
from 98109
Anaheim, CA
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Binghamton, New York 13901
2270
mi
from 98109
Binghamton, NY
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Charleston, South Carolina 29407
2419
mi
from 98109
Charleston, SC
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Cleveland, Ohio 44122
2029
mi
from 98109
Cleveland, OH
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370 Minorca Avenue
Coral Gables, Florida 33134
2729
mi
from 98109
Coral Gables, FL
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Fort Worth, Texas 76135
1662
mi
from 98109
Fort Worth, TX
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Kansas City, Missouri 64114
1507
mi
from 98109
Kansas City, MO
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Knoxville, Tennessee 37920
2110
mi
from 98109
Knoxville, TN
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Lenexa, Kansas 66219
1499
mi
from 98109
Lenexa, KS
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Meridian, Idaho 83642
399
mi
from 98109
Meridian, ID
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Mobile, Alabama 36608
2145
mi
from 98109
Mobile, AL
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1709 South Rock Road
Newton, Kansas 67114
1440
mi
from 98109
Newton, KS
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3652 Eureka Way
Redding, California 96001
487
mi
from 98109
Redding, CA
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Saint Louis, Missouri 63141
1706
mi
from 98109
Saint Louis, MO
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San Angelo, Texas 76904
1609
mi
from 98109
San Angelo, TX
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6602 Waters Avenue
Savannah, Georgia 31406
2403
mi
from 98109
Savannah, GA
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Tomball, Texas 77375
1864
mi
from 98109
Tomball, TX
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West Jordan, Utah 84088
707
mi
from 98109
West Jordan, UT
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1709 South Rock Road
Wichita, Kansas 67207
1440
mi
from 98109
Wichita, KS
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