Influenza Clinical Trial
Official title:
Post-marketing Surveillance of Annual Influenza Vaccines: Extended Vaccine Safety and Immunogenicity Evaluation
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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