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:
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
  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:


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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014