Immune Response to High-Dose vs. Standard Dose Influenza Vaccine

Status unconfirmed · Phase 4

Conditions studied: Elderly Immune System

In brief

This 5-year proposal is a randomized study of split-virus influenza vaccine (SVV) in a high-dose (HD) vs. standard-dose (SD) formulation in each of five influenza seasons to define the key determinants of vaccine-mediated protection against influenza and how these immunologic mediators may be enhanced by vaccination with a newly approved high-dose influenza vaccine in older people

Key facts

Study ID

NCT02297542

Run by

Health Sciences North Research Institute

People needed

85

Starts

2014-10-01

Expected to finish

2019-12-01

Last updated by the study team

2018-08-01

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Written informed consent provided by the participant
• Age 20-40 years old with no underlying chronic diseases or age ≥65 years old
• Willing to receive influenza vaccination
• Older cohort has received their influenza vaccine for the previous influenza season

You may not qualify if…

• Immunosuppressive disorders or medications (including oral prednisone in doses >10 mg daily)
• Have not received influenza vaccination in the past or cannot be vaccinated due to previous severe reaction to influenza vaccine, egg, latex, or thimerosol allergies, or refusal of vaccination
• Participant has received a community available influenza vaccine for the approaching influenza season
• Females who are pregnant at Visit 1 (a pregnancy test will be administered for all females of child-bearing potential)

Where it is running

• Center on Aging, UConn Health — Farmington, Connecticut, United States
• Health Sciences North Research Institute — Greater Sudbury, Ontario, Canada

Full record on ClinicalTrials.gov

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