Rapid Evaluation of Seasonal Influenza Vaccine

NCT ID: NCT00966342

Last Updated: 2009-10-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2009-11-30

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.

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.

Conditions

Influenza

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Vaccine

Everyone gets licensed Influenza vaccine

Group Type: OTHER

Fluviral 2009/10

Intervention Type: DRUG

single dose given IM .05 mL

Interventions

Fluviral 2009/10

single dose given IM .05 mL

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

University of British Columbia

Principal Investigators

David Scheifele, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

KFLA Public Health Department

Kingston, Ontario, Canada

Mt Sinai Hospital

Toronto, Ontario, Canada

CHUQ de recherché

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

H07-01465

Identifier Type: -

Identifier Source: org_study_id