A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine

Completed · Phase 4

Conditions studied: Influenza

In brief

The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US Licensed Comparator Influenza Virus Vaccine.

Key facts

Study ID

NCT00735475

Run by

Seqirus

People needed

1268

Starts

2008-10-01

Expected to finish

2009-06-01

Last updated by the study team

2018-05-23

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males aged ≥ 65 years or females of non-childbearing potential aged ≥ 65 years ;
• Written informed consent ;
• Willingness to provide a blood sample.

You may not qualify if…

• Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccines;
• Previous vaccination against influenza in 2008 or 2009 with seasonal trivalent inactivated influenza vaccine;
• Known history of Guillain-Barré Syndrome;
• Clinical signs of active infection and/or an oral temperature of greater than or equal to 100 degrees F (37.8 degrees C).
• Have active or recent and clinically significant gastrointestinal/hepatic, renal, neurological, cardiovascular, respiratory, endocrine disorders or other medical disorders;
• History of seizures;
• Confirmed or suspected immunosuppressive condition, or a previously diagnosed immunodeficiency disorder;
• Clinically significant history of malignancy
• Current treatment, or treatment with radiotherapy or cytotoxic drugs at any time during the six months prior to administration of the Study Vaccine;
• Current immunosuppressive or immunomodulative therapy;
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the Study Vaccine;
• Participation in a clinical trial or use of an investigational compound within 30 days prior to receiving the Study Vaccine ;
• Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to receiving the Study Vaccine.
• Current treatment with warfarin or other anticoagulants;
• Major congenital defects;
• Evidence, or history (within the previous 12 months) of drug or alcohol abuse;
• Unwillingness or inability to comply with the study protocol including completion of adverse event diary cards;
• History of psychiatric disorders;
• Resident of long term care facility.

Where it is running

• North Central Arkansas Medical Association — Mountain Home, Arkansas, United States
• Covance CRU, Inc — Boise, Idaho, United States
• The University of Iowa — Iowa City, Iowa, United States
• Kentucky Pediatric/ Adult Research — Bardstown, Kentucky, United States
• Saint Louis University Medical Center — St Louis, Missouri, United States
• University of Rochester School of Medicine and Dentistry — Rochester, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Covance CRU, Inc. — Portland, Oregon, United States
• Primary Physicians Research, Inc. — Pittsburgh, Pennsylvania, United States
• Clinical Partners, LLC — Johnston, Rhode Island, United States
• Vanderbilt Medical Center — Nashville, Tennessee, United States
• Covance CRU Inc. — Austin, Texas, United States

Full record on ClinicalTrials.gov

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