Rapid Evaluation of Seasonal Influenza Vaccine
Rapid Evaluation of Seasonal Influenza Vaccine
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.
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