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

Use our guide to learn which trials are right for you!

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
682
mi
from 43215
Omaha, NE
Click here to add this to my saved trials
Anaheim, California 92801
1960
mi
from 43215
Anaheim, CA
Click here to add this to my saved trials
Bardstown, Kentucky 40004
198
mi
from 43215
Bardstown, KY
Click here to add this to my saved trials
Biloxi, Mississippi 39531
738
mi
from 43215
Biloxi, MS
Click here to add this to my saved trials
1716
mi
from 43215
Boise, ID
Click here to add this to my saved trials
126
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80920
1163
mi
from 43215
Colorado Springs, CO
Click here to add this to my saved trials
Council Bluffs, Iowa 51501
678
mi
from 43215
Council Bluffs, IA
Click here to add this to my saved trials
911
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
Hollywood, Florida 33024
978
mi
from 43215
Hollywood, FL
Click here to add this to my saved trials
Jacksonville, Florida 32205
669
mi
from 43215
Jacksonville, FL
Click here to add this to my saved trials
Las Vegas, Nevada 89104
1756
mi
from 43215
Las Vegas, NV
Click here to add this to my saved trials
1725
mi
from 43215
Meridian, ID
Click here to add this to my saved trials
Metairie, Louisiana 70427
798
mi
from 43215
Metairie, LA
Click here to add this to my saved trials
Milford, Connecticut 06460
529
mi
from 43215
Milford, CT
Click here to add this to my saved trials
Mount Pleasant, South Carolina 29464
525
mi
from 43215
Mount Pleasant, SC
Click here to add this to my saved trials
Nashville, Tennessee 37212
332
mi
from 43215
Nashville, TN
Click here to add this to my saved trials
Norfolk, Virginia 23507
423
mi
from 43215
Norfolk, VA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
849
mi
from 43215
Oklahoma City, OK
Click here to add this to my saved trials
Redding, California 96001
2058
mi
from 43215
Redding, CA
Click here to add this to my saved trials
Rochester, New York 14609
355
mi
from 43215
Rochester, NY
Click here to add this to my saved trials
Saint Louis, Missouri 63104
394
mi
from 43215
Saint Louis, MO
Click here to add this to my saved trials
Salt Lake City, Utah 84109
1513
mi
from 43215
Salt Lake City, UT
Click here to add this to my saved trials
San Diego, California 92117
1951
mi
from 43215
San Diego, CA
Click here to add this to my saved trials
South Jordan, Utah 84095
1517
mi
from 43215
South Jordan, UT
Click here to add this to my saved trials
Stockbridge, Georgia 30281
448
mi
from 43215
Stockbridge, GA
Click here to add this to my saved trials
984
mi
from 43215
Tomball, TX
Click here to add this to my saved trials
Warwick, Rhode Island 02886
617
mi
from 43215
Warwick, RI
Click here to add this to my saved trials
West Jordan, Utah 83642
1517
mi
from 43215
West Jordan, UT
Click here to add this to my saved trials
785
mi
from 43215
Wichita, KS
Click here to add this to my saved trials
Wilmington, North Carolina 28401
485
mi
from 43215
Wilmington, NC
Click here to add this to my saved trials
Winston-Salem, North Carolina 27045
306
mi
from 43215
Winston-Salem, NC
Click here to add this to my saved trials