Evaluation of Seasonal Influenza Vaccine for 2010-2011 in Young Children
Condition: Seasonal 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 children 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 trivalent inactivated product (regular
      seasonal influenza vaccine)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 children who received
      one or two doses of 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 200 children (50 at each site) 12-59 month olds, 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 one or two doses of
      the adjuvanted H1N1 vaccine before January 31, 2010. To eligible participants do not need a
      previous years seasonal flu vaccine(TIV)however, this will be recorded.

      The study involves 1-2 vaccination visits 28 days apart. Those children who have not received
      a previous dose of TIV will receive a second dose at visit # 2. 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 at each study visit (2 or 3 visits depending on previous TIV
      history) to measure immune responses to the seasonal vaccine.

      The study will take 21-42 days to complete, depending upon whether or not the child received
      a previous dose of seasonal TIV vaccination. The 4 study sites are in Vancouver, Calgary,
      Montreal and Halifax.

      Each subject's parent will be asked to keep daily notes of any changes at the injection site
      (pain, redness, swelling) and any general symptoms (such as irritability, drowsiness,
      decreased appetite, sleep disturbance,sweating and shivering, including your axilla or rectal
      temperature, for 7 days after each vaccination. Major health changes will be assessed for 21
      days post vaccination.
    

Intervention name(s): Fluviral
Intervention type(s): Biological
Intervention description(s): 0.25 mL Fluviral for children up to and including 35 months of age 0.50 mL Fluviral for children 36-59 months of age
Other intervention name(s): Influenza Virus Vaccine; Trivalent, Inactivated; Split Virion; Prepared in Eggs
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vaccine; Seasonal Influenza Vaccine; Influenza Vaccine; Vaccine Safety; Vaccine Immunogenicity; Fluviral 2010-2011