Rapid Evaluation of Seasonal Influenza Vaccine

University of British Columbia

Status and phase: Withdrawn; Phase 1

Conditions: Influenza

Treatments: Drug: Fluviral 2009/10

Study type: Interventional

Funder types: Other

Identifiers

NCT00966342

H07-01465

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Vaccine

Other group

Description:

Everyone gets licensed Influenza vaccine

Treatment:

Drug: Fluviral 2009/10