Status:
COMPLETED
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
Lead Sponsor:
Seqirus
Conditions:
Influenza
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
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.
Eligibility Criteria
Inclusion
- Males aged ≥ 65 years or females of non-childbearing potential aged ≥ 65 years ;
- Written informed consent ;
- Willingness to provide a blood sample.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
1268 Patients enrolled
Trial Details
Trial ID
NCT00735475
Start Date
October 1 2008
End Date
June 1 2009
Last Update
May 23 2018
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
North Central Arkansas Medical Association
Mountain Home, Arkansas, United States, 72635
2
Covance CRU, Inc
Boise, Idaho, United States, 83704
3
The University of Iowa
Iowa City, Iowa, United States, 52242
4
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, United States, 40004