Rapid Evaluation of Seasonal Influenza Vaccine

This study has been withdrawn prior to enrollment.
(New studies are being offered)
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00966342
First received: August 24, 2009
Last updated: October 21, 2009
Last verified: October 2009
  Purpose

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 Intervention Phase
Influenza
Drug: Fluviral 2009/10
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Post-marketing Surveillance of Annual Influenza Vaccines: Extended Vaccine Safety and Immunogenicity Evaluation

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: August 2009
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Vaccine
Everyone gets licensed Influenza vaccine
Drug: Fluviral 2009/10
single dose given IM .05 mL

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.
  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  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: NCT00966342

Locations
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
Investigators
Principal Investigator: David Scheifele, Dr. University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. David Scheifele, University of British Columbia
ClinicalTrials.gov Identifier: NCT00966342     History of Changes
Other Study ID Numbers: H07-01465
Study First Received: August 24, 2009
Last Updated: October 21, 2009
Health Authority: Canada: Health Canada

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

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 October 16, 2014