Safety and Protectiveness of the Seasonal Influenza Vaccine for 2010-2011
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      This study will assess the safety of seasonal influenza vaccination in people who had the
      adjuvanted H1N1 vaccine last year. It will also measure residual immunity to the H1N1 virus
      and immune responses to the seasonal vaccine. It will be carried out before the new vaccine
      is released for general use so that we have an accurate picture of vaccine safety and
      responses for other Canadians.

      A total of 320 adults (64 at each site) 20 to 59 years old, are being asked to participate in
      this study. A research nurse will conduct a telephone screening with potential participants
      to determine if they are eligible for the study. Volunteers must have had adjuvanted H1N1
      vaccine before January 31, 2010.

      The study involves 2 vaccination visits 10 days part. At one visit seasonal vaccine will be
      given and at the other a placebo vaccine will be given. Which vaccine is given first will be
      determined by random chance, the details of which will not be released until study end. After
      each vaccination, there will be contacts 1 and 7 days later for a description of any symptoms
      experienced. A blood sample will be requested at the first and last visits (visit 3) to
      measure immune responses to the seasonal vaccine.

      The study will take 21-38 days to complete, depending upon the vaccination sequence and
      availability. Total time required to take part is about 2.5 hours. The 3 study visits will
      occur at a clinic in Vancouver, Calgary, Ottawa, Montreal or Quebec City.

      Each subject will be asked to keep daily notes of any changes at the injection site (pain,
      redness, swelling) and any general symptoms (such as headache, tiredness, body aches),
      including your oral temperature, for 7 days after each vaccination. Major health changes will
      be assessed for 21 days post 'vaccination'

      A special Safety Board will review the results of the first vaccinations and advise whether
      it is reasonable to continue the study or not.
    

Intervention name(s): Fluviral 2010/11 Tri-valent Seasonal Influenza vaccine; Fluviral 2010/11 Tri-valent Seasonal Influenza vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 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; 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
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Vaccine; Seasonal Influenza vaccine; Influenza vaccine; Vaccine safety; Vaccine immunogenicity; Fluviral 2010/11