Status:
COMPLETED
Immunogenicity and Safety Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) in Adults Aged 50 Years and Older
Lead Sponsor:
Alachua Government Services, Inc.
Conditions:
Influenza
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
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, t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
3208 Patients enrolled
Trial Details
Trial ID
NCT00782431
Start Date
November 1 2008
End Date
July 1 2009
Last Update
January 2 2026
Active Locations (30)
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1
Coastal Clinical Research, Inc.
Mobile, Alabama, United States, 36608
2
Quality of Life Medical & Research Center, LLC
Tucson, Arizona, United States, 85712
3
Benchmark Research, San Francisco
Sacramento, California, United States, 95816
4
California Research Foundation
San Diego, California, United States, 92103-6204