NCT02263040

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Mount Sinai Hospital, Canada · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Fluzone High-Dose	Influenza vaccine
BIOLOGICAL	Fluzone (standard dose)	Influenza vaccine

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-07-01
• Completion: 2016-12-31
• First posted: 2014-10-13
• Last updated: 2019-01-28
• Results posted: 2019-01-28

Locations

1 site across 1 country: Canada