NCT01368796

Comparison of 4 Influenza Vaccines in Seniors

Controlled Comparison in Canadian Seniors of Seasonal Influenza Vaccines for 2011-2012

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 953 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Influenza Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Agriflu	0.5mL dose IM vaccination
BIOLOGICAL	Fluad	0.5mL dose of vaccine given IM
BIOLOGICAL	Intanza	0.5mL dose vaccine given IM
BIOLOGICAL	Vaxigrip	0.5mL dose vaccine given IM

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-12-01
• Completion: 2012-05-01
• First posted: 2011-06-08
• Last updated: 2015-04-15

Locations

8 sites across 1 country: Canada