Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2009
End Date:December 2010

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A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Adult Subjects 18 or More Years of Age

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1
S-OIV (swine flu) vaccine in non-elderly and elderly adults.


Inclusion Criteria:

- Adults 18 years of age and older in good health as determined by medical history,
physical assessment and clinical judgement of the investigator and without influenza
within the past 6 months.

Exclusion Criteria:

- History of serious disease.

- History of serious reaction following administration of vaccine or hypersensitivity
to vaccine components.

- Known or suspected impairment/alteration of immune function.

- Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week
before or after each study vaccination.

- Sexually active women of childbearing potential must use acceptable birth control
during the treatment phase of the study.

- For additional entry criteria, please refer to protocol.
We found this trial at
21
sites
Warwick, Rhode Island 02886
615
mi
from 43215
Warwick, RI
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Burke, Virginia 22015
317
mi
from 43215
Burke, VA
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Cary, North Carolina 27518
373
mi
from 43215
Cary, NC
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Dallas, Texas 75010
907
mi
from 43215
Dallas, TX
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Endwell, New York 13760
393
mi
from 43215
Endwell, NY
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Erie, Pennsylvania 16506
213
mi
from 43215
Erie, PA
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Fairfax, Virginia 22030
314
mi
from 43215
Fairfax, VA
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Franklin, Ohio 45005
0
mi
from 43215
Franklin, OH
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994
mi
from 43215
Houston, TX
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Jefferson Hills, Pennsylvania 15025
164
mi
from 43215
Jefferson Hills, PA
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Lenexa, Kansas 66219
629
mi
from 43215
Lenexa, KS
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Miami, Florida
994
mi
from 43215
Miami, FL
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Oklahoma City, Oklahoma 73103
849
mi
from 43215
Oklahoma City, OK
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Omaha, Nebraska 68134
682
mi
from 43215
Omaha, NE
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Raleigh, North Carolina 27609
372
mi
from 43215
Raleigh, NC
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
344
mi
from 43215
Richmond, VA
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Rochester, New York 14609
356
mi
from 43215
Rochester, NY
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1513
mi
from 43215
Salt Lake City, UT
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1511
mi
from 43215
Salt Lake City, UT
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?
mi
from 43215
Tlalpan,
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Winston-Salem, North Carolina 27103
306
mi
from 43215
Winston-Salem, NC
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