Safety and Protectiveness of the Seasonal Influenza Vaccine for 2010-2011

Summary

The seasonal influenza vaccination program for 2010-2011 will be the first to follow the H1N1 pandemic of 2009. Many Canadians either had the H1N1 infection or the adjuvanted H1N1 vaccine. Both H1N1 infection and adjuvanted vaccine produced strong immune responses which could last for some time.

The seasonal influenza vaccine for this fall will be a "normal" product once again, without adjuvant. It will contain 3 strains of killed, split-apart viruses that might circulate this winter, including the H1N1 pandemic strain. It is theoretically possible that giving the H1N1-containing seasonal vaccine to people who still have some immunity to H1N1 virus could result in more frequent side-effects. However, there is no good evidence that pre-existing immunity to a strain in the vaccine does increase side-effects. In short, there could be nothing out of the ordinary this fall but it would be prudent to check this before public flu vaccination programs begin.

Conditions

• Influenza

Interventions

BIOLOGICAL

Fluviral 2010/11 Tri-valent Seasonal Influenza vaccine

Vaccination of .05mL of Fluviral vaccine will be injected once at either visit 1 or 2 depending upon randomization in the deltoid muscle of the non-dominant arm

BIOLOGICAL

Fluviral 2010/11 Tri-valent Seasonal Influenza vaccine

Vaccination of .05mL of Fluviral vaccine will be injected once at either visit 1 or 2 depending upon randomization in the deltoid muscle of the non-dominant arm

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• GlaxoSmithKline

  collaborator INDUSTRY

• University of British Columbia

  lead OTHER

Principal Investigators

• David Scheifele, Dr. · University of British Columbia

• Simon Dobson, Dr. · University of British Columbia

• Laura Sauve, Dr. · University of British Columbia

• Tobias Kollmann, Dr. · University of British Columbia

• Keswadee Lapphra, Dr. · University of British Columbia

• Brian Ward, Dr. · McGill University Health Centre - Vaccine Study Centre

• Marc Dionne, Dr. · Unité de Recherche en Santé Publique (CHUQ)

• Vladimir Gilca, Dr. · Unité de Recherche en Santé Publique (CHUQ)

• Gaston DeSerres, Dr. · Unité de Recherche en Santé Publique (CHUQ)

• Curtis Cooper, Dr. · The Ottawa Hospital Research Institute, University of Ottawa

• Otto Vanderkooi, Dr. · ACHIEVE Research, Alberta Children's Hospital, University of Calgary and Alberta Health Services

• James Kellner, Dr. · ACHIEVE Research, Alberta Children's Hospital, University of Calgary and Alberta Health Services

• Judy MacDonald, Dr. · ACHIEVE Research, Alberta Children's Hospital, University of Calgary and Alberta Health Services

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

20 Years

Max Age

59 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-08-31

Primary Completion

2010-09-30

Completion

2010-09-30

Countries

• Canada

Study Locations