Rapid Evaluation of Seasonal Influenza Vaccine

Phase 1

Withdrawn

• Conditions: Influenza
• Interventions: Drug: Fluviral 2009/10

• Registration Number: NCT00966342
• Lead Sponsor: University of British Columbia

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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-24
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-26
• Status Verified: 2009-10
• Primary Completion: 2009-10
• Last Update Submitted: 2009-10-21
• Last Update Posted: 2009-10-23
• Study Completion: 2009-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaccine	Fluviral 2009/10	Everyone gets licensed Influenza vaccine

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Mt Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada

KFLA Public Health Department; 🇨🇦 Kingston, Ontario, Canada

CHUQ de recherché; 🇨🇦 Quebec City, Quebec, Canada