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
This study has been completed.
Sponsor:
CSL Limited
Information provided by (Responsible Party):
CSL Limited
ClinicalTrials.gov Identifier:
NCT00735475
First received: August 13, 2008
Last updated: September 6, 2011
Last verified: September 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: CSL Limited Influenza Virus Vaccine (Afluria®) Biological: US Licensed Influenza Virus Vaccine (Fluzone®) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
| Official Title: | A Phase IV, Randomized, Observer-Blind, Multi-Center, Non Inferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Inactivated Split-Virion Influenza Vaccine in Adults Aged Greater Than or Equal to 65 Years |
Resource links provided by NLM:
MedlinePlus related topics:
Flu
Drug Information available for:
Influenza Vaccines
U.S. FDA Resources
Further study details as provided by CSL Limited:
Primary Outcome Measures:
- Geometric Mean Titer 21 Days After the Study Vaccination [ Time Frame: 21 days after vaccination ] [ Designated as safety issue: No ]
- Percentage of Participants With Seroconversion 21 Days After the Study Vaccination [ Time Frame: 21 days after vaccination ] [ Designated as safety issue: No ]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:
- Frequency and Intensity of Local and Systemic Solicited Symptoms [ Time Frame: 5 days after vaccination ] [ Designated as safety issue: Yes ]
- Duration of Local and Systemic Solicited Symptoms [ Time Frame: 5 days after vaccination ] [ Designated as safety issue: Yes ]
- Frequency and Intensity of Unsolicited Adverse Events (UAEs) [ Time Frame: 21 days after vaccination ] [ Designated as safety issue: Yes ]Abbreviation UAE stands for Unsolicited Adverse Event.
- Serious Adverse Events [ Time Frame: 180 days after vaccination ] [ Designated as safety issue: Yes ]
- New Onsets of Chronic Illness [ Time Frame: 180 days after vaccination ] [ Designated as safety issue: Yes ]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).
| Enrollment: | 1268 |
| Study Start Date: | October 2008 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Afluria® |
Biological: CSL Limited Influenza Virus Vaccine (Afluria®)
A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.
|
| Active Comparator: Fluzone® |
Biological: US Licensed Influenza Virus Vaccine (Fluzone®)
A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.
|
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Males aged ≥ 65 years or females of non-childbearing potential aged ≥ 65 years ;
- Written informed consent ;
- Willingness to provide a blood sample.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735475
Locations
| United States, Arkansas | |
| North Central Arkansas Medical Association | |
| Mountain Home, Arkansas, United States, 72635 | |
| United States, Idaho | |
| Covance CRU, Inc | |
| Boise, Idaho, United States, 83704 | |
| United States, Iowa | |
| The University of Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kentucky | |
| Kentucky Pediatric/ Adult Research | |
| Bardstown, Kentucky, United States, 40004 | |
| United States, Missouri | |
| Saint Louis University Medical Center | |
| St Louis, Missouri, United States, 63104 | |
| United States, New York | |
| University of Rochester School of Medicine and Dentistry | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27704 | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229 | |
| United States, Oregon | |
| Covance CRU, Inc. | |
| Portland,, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Primary Physicians Research, Inc. | |
| Pittsburgh, Pennsylvania, United States, 15241 | |
| United States, Rhode Island | |
| Clinical Partners, LLC | |
| Johnston, Rhode Island, United States, 02919 | |
| United States, Tennessee | |
| Vanderbilt Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Covance CRU Inc. | |
| Austin, Texas, United States, 78752 | |
Sponsors and Collaborators
CSL Limited
More Information
No publications provided
| Responsible Party: | CSL Limited |
| ClinicalTrials.gov Identifier: | NCT00735475 History of Changes |
| Other Study ID Numbers: | CSLCT-USF-07-41 |
| Study First Received: | August 13, 2008 |
| Results First Received: | July 3, 2011 |
| Last Updated: | September 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013