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

Completed · Phase 3

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT00782431

Run by

Alachua Government Services, Inc.

People needed

3208

Starts

2008-11-01

Expected to finish

2009-07-01

Last updated by the study team

2026-01-02

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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