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

NCT02297542 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2018-08-01

No results posted yet for this study

Summary

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

Conditions

  • Elderly Immune System

Interventions

BIOLOGICAL

Flu Vaccine

Sponsors & Collaborators

  • UConn Health

    collaborator OTHER

  • Health Sciences North Research Institute

    lead OTHER

Principal Investigators

  • Janet E McElhaney, MD · Health Sciences North Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States
  • Canada

Study Locations

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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 NCT02297542 on ClinicalTrials.gov