Rapid Evaluation of Seasonal Influenza Vaccine

Influenza Clinical Trial

Official title:

Post-marketing Surveillance of Annual Influenza Vaccines: Extended Vaccine Safety and Immunogenicity Evaluation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00966342
• Other study ID #: H07-01465
• Status: Withdrawn
• Phase: Phase 1
• First received: August 24, 2009
• Last updated: October 21, 2009
• Start date: August 2009
• Est. completion date: November 2009

Study information

• Verified date: October 2009
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 300
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• Fluviral 2009/10
single dose given IM .05 mL

Locations

Country	Name	City	State
Canada	KFLA Public Health Department	Kingston	Ontario
Canada	CHUQ de recherché	Quebec City	Quebec
Canada	Mt Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		21 days	Yes