Immunogenicity and Safety Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) in Adults Aged 50 Years and Older



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:50 - Any
Updated:4/21/2016
Start Date:November 2008
End Date:July 2009

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Phase 3 Double Blind Clinical Study of Effectiveness and Safety of Vero Cell-Derived, Trivalent, Seasonal Influenza Vaccine in Adults Aged 50 Years and Older

The purpose of this study is to demonstrate the effectiveness (seroprotection and
seroconversion as measured by the hemagglutination inhibition [HI] assay) of an
investigational Vero cell-derived, trivalent, seasonal influenza vaccine in adults 50 years
of age and older. Subjects will be randomized in a double-blind fashion to receive a single
intramuscular injection of either the investigational vaccine or a licensed egg-derived
seasonal influenza vaccine. Blood will be drawn from all subjects for a determination of HI
antibody titers on Days 0 and 21, body temperature and injection site reactions will be
monitored daily for 7 days. In addition, subjects will be monitored for adverse events and
rises in body temperature until Day 21 and again until Day 180.


Inclusion Criteria:

- Are 50 years of age or older on the day of screening

- Have an understanding of the study, agree to its provisions, have the ability to
adhere to the provisions of the study and give written informed consent prior to
study entry

- If female and capable of bearing children,have a negative urine pregnancy test result
within 24 hours prior to the vaccination on Study Day 0 and agree to employ adequate
birth control measures.

Exclusion Criteria:

- History of severe allergic reaction or anaphylaxis to egg protein or any other
component of the Vero cell-derived influenza vaccine or the egg-derived influenza
vaccine

- Oral temperature of >= 99.5°F (37.5°C) on the day of vaccination in this study (Note:
Subjects meeting this exclusion criterion may be rescheduled for vaccination and
study entry at a later date if certain requirements [in the study protocol] are met)

- Rash or dermatologic condition or tattoos which may interfere with injection site
reaction rating

- Blood transfusion or immunoglobulins received within 90 days of study entry

- Live vaccine received within 4 weeks or inactivated vaccine or subunit vaccine
received within 2 weeks of study entry

- Previous vaccination against influenza for the 2008/2009 northern hemisphere
influenza season

- Functional or surgical asplenia (e.g. from a history of hemoglobinopathies,
leukemias, or lymphomas)

- Diagnosed immunodeficiency as a result of a pathological condition

- Pharmacologically induced immunodeficiency as a result of prescribed administration
of corticosteroids (e.g., any systemic administration of corticosteroids or an
inhaled dose equivalent to 800 mg of beclomethasone dipropionate) or
chemotherapeutics or as a result of radiation therapy or any other modality capable
of altering normal immunologic response

- Known or suspected problem with drug or alcohol abuse

- Investigational drug received within 6 weeks prior to study entry or concurrent
participating in a clinical study that includes the administration of an
investigational product

- Subjects who are a member of the team conducting this study or are in a dependent
relationship with the study investigator. Dependent relationships include close
relatives (i.e., children, spouse/partner, siblings, parents) as well as employees of
the investigator.
We found this trial at
29
sites
3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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4085 University Blvd S # 1
Jacksonville, Florida 32216
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400 Gresham Dr
Norfolk, Virginia 23507
757-627-7446
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Austin, Texas 78705
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Coral Cables, Florida 33134
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Endwell, New York 13760
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Fairfax, Virginia 22030
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Fort Worth, Texas 76135
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Kansas City, Missouri 64114
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Lenexa, Kansas 66219
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Lexington, Kentucky 40509
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Mobile, Alabama 36608
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Mt. Pleasant, South Carolina 29464
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Omaha, Nebraska 68134
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Overland Park, Kansas 23112
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Pembrook Pines, Florida 33024
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Plano, Texas 75093
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Rochester, New York 14609
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Sacramento, California 95816
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San Angelo, Texas 76904
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San Diego, California 92103
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San Francisco, California 94102
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St. Louis, Missouri 63141
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St. Louis, Missouri 63141
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Stockbridge, Georgia 30281
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