MedTrace Logo

High Dose vs. Standard Influenza Vaccine in Adult SOT

NCT03139565 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2020-10-22

No results posted yet for this study

Summary

The study will test whether a high dose influenza vaccination results in improved immunogenicity in adult SOT recipients as compared to standard vaccine. This will be a single center prospective observer-blind randomized controlled trial conducted at the Toronto General Hospital Multi-Organ Transplant Unit, University Health Network, Toronto, Ontario, Canada.

Conditions

Interventions

BIOLOGICAL

Fluzone High-dose Influenza Vaccine

This treatment consists of 60 microgram of each influenza antigen provided as a single injection, which will be injected in the deltoid muscle of the non-dominant arm.

BIOLOGICAL

Standard 2016-2017 Flu vaccine

The intramuscular preparation of the vaccine used for the control group will be the Standard influenza vaccine made available by public health. The intramuscular dose (standard 0.5 mL) will contain 15 microgram antigen from each strain and delivered in the deltoid muscle by trained personnel.

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Deepali Kumar, MD · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-06-30
Completion
2020-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03139565 on ClinicalTrials.gov