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A Pilot Study to Assess the Immunogenicity and Reactogenicity of High Versus Standard Dose TIV

Influenza Clinical Trial

Official title:
A Pilot Study to Assess the Immunogenicity and Reactogenicity of High Versus Standard Dose Trivalent Inactivated Influenza Vaccine for Healthcare Workers

Clinical Trial Summary

The objective of this pilot study is to assess the immunogenicity and reactogenicity of Fluzone High Dose with Fluzone (standard adult dose) influenza vaccines in healthcare workers.

Clinical Trial Description

This is a prospective, randomized controlled, observer blind trial of Fluzone High Dose trivalent inactivated influenza vaccine (HDTIV) versus Fluzone, standard dose TIV (SDTIV) in 100 healthcare workers 18-64 years of age. Participants will receive, in a 1:1 ratio, one dose of either SDTIV or HDTIV containing the strains of influenza virus as recommended by the World Health Organization for the season of recruitment. All adverse events will be collected for 7 days following the injection, serious adverse events will be collected through day 21, and serum for antibody testing will be obtained on day 0 and day 21. The primary outcome will be seroconversion to each strain of vaccine included in the vaccine, as measured by change in hemagglutination inhibition assay (HAI) titer between day 0 to day 21. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02263040
Study type Interventional
Source Mount Sinai Hospital, Canada
Contact
Status Completed
Phase Phase 1/Phase 2
Start date October 2014
Completion date December 31, 2016
View Details
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