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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00735475
Recruitment Status : Completed
First Posted : August 15, 2008
Results First Posted : September 1, 2011
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Seqirus

Study Description
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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.

Condition or disease Intervention/treatment Phase
Influenza Biological: CSL Limited Influenza Virus Vaccine (Afluria®) Biological: US Licensed Influenza Virus Vaccine (Fluzone®) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : October 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : June 2009

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Geometric Mean Titer 21 Days After the Study Vaccination [ Time Frame: 21 days after vaccination ]
  2. Percentage of Participants With Seroconversion 21 Days After the Study Vaccination [ Time Frame: 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 :
  1. Frequency and Intensity of Local and Systemic Solicited Symptoms [ Time Frame: 5 days after vaccination ]
  2. Duration of Local and Systemic Solicited Symptoms [ Time Frame: 5 days after vaccination ]
  3. Frequency and Intensity of Unsolicited Adverse Events (UAEs) [ Time Frame: 21 days after vaccination ]
    Abbreviation UAE stands for Unsolicited Adverse Event.

  4. Serious Adverse Events [ Time Frame: 180 days after vaccination ]
  5. New Onsets of Chronic Illness [ Time Frame: 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).


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00735475


Locations
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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
Saint 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
Seqirus
Investigators
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Study Director: Clinical Director Vaccines Seqirus
More Information
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Responsible Party: Seqirus
ClinicalTrials.gov Identifier: NCT00735475    
Other Study ID Numbers: CSLCT-USF-07-41
First Posted: August 15, 2008    Key Record Dates
Results First Posted: September 1, 2011
Last Update Posted: May 23, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs