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Rapid Evaluation of Seasonal Influenza 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: NCT00966342
Recruitment Status : Withdrawn (New studies are being offered)
First Posted : August 26, 2009
Last Update Posted : October 23, 2009
Information provided by:
University of British Columbia

Brief Summary:
This is an invitation to consider taking part in a research study occurring just before the upcoming influenza vaccination program across Canada. The purpose of the study is to closely assess influenza vaccine safety and immune responses, as part of a nationwide, annual surveillance project sponsored by the Public Health Agency of Canada. Such scrutiny is important given the changing nature of flu vaccines from year to year.

Condition or disease Intervention/treatment Phase
Influenza Drug: Fluviral 2009/10 Phase 1

Detailed Description:

Trivalent inactivated vaccines (TIVs) are the principal tools for minimizing seasonal influenza morbidity and mortality in populations at increased risk of adverse outcomes. To keep pace with the evolution of circulating viruses the composition of TIVs is annually updated. Depending upon circumstances, the seasonal formulation may contain 1-3 new variant strains representing Canada's supply of H1N1, H3N2 and B 2009 vaccine. Standardized manufacturing processes favour consistent vaccine safety and immunogenicity profiles from year to year but unanticipated differences can and do occur. As a consequence of the unusual occurrence of "oculorespiratory syndrome" in recipients of a Canadian-made TIV for 2000-2001, the Canadian regulatory agency has required pre-approval clinical testing of seasonal vaccines in adults. This small scale testing (120 subjects) cannot exclude the occurrence of infrequent, troublesome adverse effects. Expanded testing is desirable and would best be done soon after vaccines are approved for distribution so that results could inform the public vaccination programs that follow. Having an established capacity for rapid evaluation of a new influenza vaccine will be invaluable in the event of a pandemic, when vaccines will be less thoroughly tested before being made available to protect the public.

The objectives of this study are two-fold:

  1. To assess the safety and immunogenicity of a seasonal TIV influenza vaccine quickly enough to inform subsequent public delivery programs.
  2. To use the opportunity to refine preparedness for rapid evaluation of a pandemic influenza vaccine.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Post-marketing Surveillance of Annual Influenza Vaccines: Extended Vaccine Safety and Immunogenicity Evaluation
Study Start Date : August 2009
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
Everyone gets licensed Influenza vaccine
Drug: Fluviral 2009/10
single dose given IM .05 mL

Primary Outcome Measures :
  1. Assess the safety and immunogenicity of the licensed Influenza vaccine Fluviral 2009/10 measured at 7 and 21 days for safety and 21 days for immunogenicity [ Time Frame: 21 days ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Eligibility Inclusion:

  • Good general health
  • Written informed consent
  • Adults 20-64 years of age

Exclusion Criteria:

  • compromised immune system
  • allergies to eggs or thimerosol
  • life-threatening reaction to previous Flu vaccine
  • chronic illness, bleeding disorder

any Flu vaccine within 6 mths planning any other vaccine during study

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): NCT00966342

Canada, Ontario
KFLA Public Health Department
Kingston, Ontario, Canada
Mt Sinai Hospital
Toronto, Ontario, Canada
Canada, Quebec
CHUQ de recherché
Quebec City, Quebec, Canada
Sponsors and Collaborators
University of British Columbia
Principal Investigator: David Scheifele, Dr. University of British Columbia

Responsible Party: Dr. David Scheifele, University of British Columbia
ClinicalTrials.gov Identifier: NCT00966342     History of Changes
Other Study ID Numbers: H07-01465
First Posted: August 26, 2009    Key Record Dates
Last Update Posted: October 23, 2009
Last Verified: October 2009

Keywords provided by University of British Columbia:
influenza vaccine
pandemic preparedness

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs