Immunogenicity and Safety Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) in Adults Aged 50 Years and Older
NCT ID: NCT00782431
Last Updated: 2026-01-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3208 participants
INTERVENTIONAL
2008-11-30
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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1
Vero cell-derived, trivalent, seasonal influenza vaccine
Vero cell derived, trivalent, seasonal influenza vaccine
Single intramuscular injection
2
Licensed egg-derived, trivalent seasonal influenza vaccine
Licensed egg-derived, trivalent seasonal influenza vaccine
Single intramuscular injection
Interventions
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Vero cell derived, trivalent, seasonal influenza vaccine
Single intramuscular injection
Licensed egg-derived, trivalent seasonal influenza vaccine
Single intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
ALL
Yes
Sponsors
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Alachua Government Services, Inc.
INDUSTRY
Responsible Party
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Locations
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Coastal Clinical Research, Inc.
Mobile, Alabama, United States
Quality of Life Medical & Research Center, LLC
Tucson, Arizona, United States
Benchmark Research, San Francisco
Sacramento, California, United States
California Research Foundation
San Diego, California, United States
Benchmark Research San Francisco
San Francisco, California, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Heartland Research Associates LLC
Wichita, Kansas, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States
Center for Pharmaceutical Research
Kansas City, Missouri, United States
Radiant Research, Inc.
St Louis, Missouri, United States
Sundance Clinical Research
St Louis, Missouri, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
Regional Clinical Research, Inc.
Endwell, New York, United States
Rochester Clinical Research Inc.
Rochester, New York, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Omega Medical Research
Warwick, Rhode Island, United States
Palmetto Medical Research
Mt. Pleasant, South Carolina, United States
Clinical Research Associates, Inc. - Nashville
Nashville, Tennessee, United States
Benchmark Research Austin
Austin, Texas, United States
Benchmark Research Ft. Worth
Fort Worth, Texas, United States
Research Across America
Plano, Texas, United States
Benchmark Research San Angelo
San Angelo, Texas, United States
Pi-Coor Clinical Research
Fairfax, Virginia, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States
Countries
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References
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Ehrlich HJ, Berezuk G, Fritsch S, Aichinger G, Singer J, Portsmouth D, Hart MK, El-Amin W, Kistner O, Barrett PN. Clinical development of a Vero cell culture-derived seasonal influenza vaccine. Vaccine. 2012 Jun 19;30(29):4377-86. doi: 10.1016/j.vaccine.2011.11.114. Epub 2011 Dec 13.
Other Identifiers
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720801
Identifier Type: -
Identifier Source: org_study_id
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