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

Seqirus

Status and phase: Completed; Phase 4

Conditions: Influenza

Treatments: Biological: CSL Limited Influenza Virus Vaccine (Afluria®); Biological: US Licensed Influenza Virus Vaccine (Fluzone®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00735475

CSLCT-USF-07-41

Details and patient eligibility

About

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.

Enrollment: 1,268 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,268 participants in 2 patient groups

Afluria®

Experimental group

Treatment:

Biological: CSL Limited Influenza Virus Vaccine (Afluria®)

Fluzone®

Active Comparator group

Treatment:

Biological: US Licensed Influenza Virus Vaccine (Fluzone®)