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
- Conditions
- Influenza
- Interventions
- Biological: US Licensed Influenza Virus Vaccine (Fluzone®)Biological: CSL Limited Influenza Virus Vaccine (Afluria®)
- Registration Number
- NCT00735475
- Lead Sponsor
- Seqirus
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1268
- Males aged ≥ 65 years or females of non-childbearing potential aged ≥ 65 years ;
- Written informed consent ;
- Willingness to provide a blood sample.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fluzone® US Licensed Influenza Virus Vaccine (Fluzone®) - Afluria® CSL Limited Influenza Virus Vaccine (Afluria®) -
- Primary Outcome Measures
Name Time Method Geometric Mean Titer 21 Days After the Study Vaccination 21 days after vaccination Percentage of Participants With Seroconversion 21 Days After the Study Vaccination 21 days after vaccination Seroconversion rate was defined as the proportion of participants with a HI titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or with a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.
- Secondary Outcome Measures
Name Time Method Frequency and Intensity of Local and Systemic Solicited Symptoms 5 days after vaccination New Onsets of Chronic Illness 180 days after vaccination A NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to the study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension).
Frequency and Intensity of Unsolicited Adverse Events (UAEs) 21 days after vaccination Abbreviation UAE stands for Unsolicited Adverse Event.
Serious Adverse Events 180 days after vaccination Duration of Local and Systemic Solicited Symptoms 5 days after vaccination
Trial Locations
- Locations (13)
Covance CRU, Inc
🇺🇸Boise, Idaho, United States
Saint Louis University Medical Center
🇺🇸Saint Louis, Missouri, United States
Clinical Partners, LLC
🇺🇸Johnston, Rhode Island, United States
Covance CRU Inc.
🇺🇸Austin, Texas, United States
North Central Arkansas Medical Association
🇺🇸Mountain Home, Arkansas, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Vanderbilt Medical Center
🇺🇸Nashville, Tennessee, United States
Kentucky Pediatric/ Adult Research
🇺🇸Bardstown, Kentucky, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Primary Physicians Research, Inc.
🇺🇸Pittsburgh, Pennsylvania, United States
The University of Iowa
🇺🇸Iowa City, Iowa, United States
Covance CRU, Inc.
🇺🇸Portland, Oregon, United States
University of Rochester School of Medicine and Dentistry
🇺🇸Rochester, New York, United States