Clinical trial NCT00966342: Rapid Evaluation of Seasonal Influenza Vaccine
Official title: Post-marketing Surveillance of Annual Influenza Vaccines: Extended Vaccine Safety and Immunogenicity Evaluation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Influenza
Keywords: vaccine
influenza
influenza vaccine
pandemic preparedness
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2009-08-26
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 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
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: KFLA Public Health Department
state: Ontario
city: Toronto
country: Canada
facility: Mt Sinai Hospital
state: Ontario
city: Quebec City
country: Canada
facility: CHUQ de recherché
state: Quebec
Study officials:
affiliation: University of British Columbia
name: David Scheifele, Dr.
role: PRINCIPAL_INVESTIGATOR
References: