Influenza Vaccine Clinical Trial
Official title:
Controlled Comparison in Canadian Seniors of Seasonal Influenza Vaccines for 2011-2012
Based on information from several years of looking at Influenza vaccination doctors know
that:
- Older adults suffer the worst illness and most deaths caused by Influenza illness of
all age groups.
- Older adults do not seem to get as good a level of protection as younger adults after
getting the usual seasonal Influenza vaccine.
Because of this information doctors wonder if one of the new seasonal Influenza vaccines is
more effective or more acceptable.
This study has been designed to answer some of these questions. On this study doctors will
compare 2 new vaccines against the usual seasonal influenza vaccine for protectiveness using
several different testing methods (including the usual tests) and for acceptability.
This study is prospective, multicenter, randomized, evaluator-blinded, controlled, parallel
group study of 3 licensed seasonal influenza vaccine products conducted in seniors, with a
4th vaccine included in a substudy of cellular immune responses.
Ambulatory adults 65+ years of age, in good health or with stable health conditions, given
TIV within the past 2 years, will be recruited in multiple Canadian centres. Subjects can be
dwelling in the community or in centers providing minimal assisted living support. A total
of 930 subjects will be enrolled.
Subjects will be centrally (electronically) randomized to receive either TIV, IDV or AIV on
Day 0. Three blood samples will be collected (1 pre and 2 post vaccination) to measure HAI
antibody responses to each virus strain (H1N1, H3N2 and B) in each vaccine, using
standardized assays. Randomly selected subsets of sera from each study group will also be
tested for neutralizing antibody and for cross-protection against drift variants of H3N2,
H1N1 and B viruses. In a subset of subjects in Vancouver, randomization assignments will
include TIV2 and extra blood samples will be obtained 0, 21 and 72 days post vaccination for
CMI testing. Safety assessments will be conducted on Day 7, Day 21 and Day 180 following
vaccination. Acceptability of each product, reflecting the frequency, severity and
tolerability of adverse effects, will be assessed.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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