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Comparison of 4 Influenza Vaccines in Seniors — PCIRNRT09  

Influenza Vaccine Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01368796
Study type Interventional
Source University of British Columbia
Contact
Status Completed
Phase Phase 4
Start date July 2011
Completion date May 2012
View Details
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