Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:65 - Any
Updated:11/2/2018
Start Date:September 8, 2017
End Date:April 19, 2018

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Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine Administered by Intramuscular Route in Participants Aged 65 Years and Older

This randomized, modified double-blind, active-controlled, multi-center trial will assess the
safety and immunogenicity of the high-dose quadrivalent influenza vaccine (QIV-HD) compared
to either the licensed or investigational high-dose trivalent influenza vaccine (TIV-HD) in
adults.

This randomized, modified double-blind, active-controlled, multi-center trial will be
conducted in healthy adults (≥ 65 years) to assess the safety and immunogenicity (geometric
mean titers and seroconversion for the 4 virus strains at 28 days post vaccination) of the
high-dose quadrivalent influenza vaccine (QIV-HD) compared to one of the high-dose trivalent
influenza vaccines (TIV-HDs) containing either the B strain from the primary lineage
(TIV-HD1; licensed vaccine [Fluzone® High-Dose] for the 2017-2018 Northern Hemisphere [NH]
influenza season) or the B strain from the alternate lineage (TIV-HD2, investigational TIV-HD
containing an alternate B strain).

Inclusion Criteria:

- Aged ≥ 65 years on the day of inclusion

- Informed consent form has been signed and dated

- Able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria:

- Participation at the time of trial enrollment (or in the 4 weeks preceding the trial
vaccination) or planned participation during the present trial period in another
clinical trial investigating a vaccine, drug, medical device, or medical procedure

- Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or
planned receipt of any vaccine prior to Visit 2

- Previous vaccination against influenza (in the preceding 6 months) with either the
trial vaccine or another vaccine

- Receipt of immune globulins, blood or blood-derived products in the past 3 months

- Known or suspected congenital or acquired immunodeficiency; or receipt of
immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,
within the preceding 6 months; or long-term systemic corticosteroid therapy
(prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

- Known systemic hypersensitivity to any of the vaccine components, or history of a
life-threatening reaction to the vaccines used in the trial or to a vaccine containing
any of the same substances

- Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on
investigator's judgment

- Deprived of freedom by an administrative or court order, or in an emergency setting,
or hospitalized involuntarily

- Alcohol or substance abuse that, in the opinion of the investigator, might interfere
with the trial conduct or completion

- Chronic illness that, in the opinion of the investigator, is at a stage where it might
interfere with trial conduct or completion

- Identified as an Investigator or employee of the Investigator or trial center with
direct involvement in the proposed trial, or identified as an immediate family member
(i.e., parent, spouse, natural or adopted child) of the Investigator or employee with
direct involvement in the proposed trial

- Personal or family history of Guillain-Barré syndrome

- Neoplastic disease or any hematologic malignancy (except localized skin or prostate
cancer that is stable at the time of vaccination in the absence of therapy and
subjects who have a history of neoplastic disease and have been disease free for ≥ 5
years)

- Moderate or severe acute illness/infection (according to Investigator judgment) on the
day of vaccination or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]). A
prospective participant should not be included in the trial until the condition has
resolved or the febrile event has subsided
We found this trial at
32
sites
Bardstown, Kentucky 40004
674
mi
from
Bardstown, KY
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Anaheim, California 92801
1155
mi
from
Anaheim, CA
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Biloxi, Mississippi 39531
720
mi
from
Biloxi, MS
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1041
mi
from
Boise, ID
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894
mi
from
Cleveland, OH
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Colorado Springs, Colorado 80920
386
mi
from
Colorado Springs, CO
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Council Bluffs, Iowa 51501
264
mi
from
Council Bluffs, IA
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347
mi
from
Dallas, TX
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Hollywood, Florida 33024
1312
mi
from
Hollywood, FL
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Jacksonville, Florida 32205
1055
mi
from
Jacksonville, FL
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Las Vegas, Nevada 89104
960
mi
from
Las Vegas, NV
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1050
mi
from
Meridian, ID
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Metairie, Louisiana 70427
693
mi
from
Metairie, LA
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Milford, Connecticut 06460
1337
mi
from
Milford, CT
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Mount Pleasant, South Carolina 29464
1067
mi
from
Mount Pleasant, SC
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Nashville, Tennessee 37212
618
mi
from
Nashville, TN
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Norfolk, Virginia 23507
1182
mi
from
Norfolk, VA
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Oklahoma City, Oklahoma 73112
158
mi
from
Oklahoma City, OK
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261
mi
from
Omaha, NE
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Redding, California 96001
1326
mi
from
Redding, CA
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Rochester, New York 14609
1122
mi
from
Rochester, NY
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Saint Louis, Missouri 63104
418
mi
from
Saint Louis, MO
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Salt Lake City, Utah 84109
779
mi
from
Salt Lake City, UT
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San Diego, California 92117
1142
mi
from
San Diego, CA
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South Jordan, Utah 84095
779
mi
from
South Jordan, UT
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Stockbridge, Georgia 30281
815
mi
from
Stockbridge, GA
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543
mi
from
Tomball, TX
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Warwick, Rhode Island 02886
1423
mi
from
Warwick, RI
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West Jordan, Utah 83642
780
mi
from
West Jordan, UT
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26
mi
from
Wichita, KS
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Wilmington, North Carolina 28401
1135
mi
from
Wilmington, NC
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Winston-Salem, North Carolina 27045
976
mi
from
Winston-Salem, NC
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