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INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure

NCT02787044 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5388

Last updated 2022-01-21

Study results available
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Summary

INVESTED will test the hypothesis that high dose trivalent influenza vaccine will reduce cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine in high-risk cardiovascular patients with a recent history of myocardial infarction or heart failure. The trial will enroll 9300 participants over one Vanguard (pilot) season and three additional influenza seasons. The primary endpoint will be a composite of all-cause mortality or cardiopulmonary hospitalization.

Conditions

Interventions

BIOLOGICAL

High Dose Trivalent Influenza Vaccine

High Dose Trivalent Influenza Vaccine

BIOLOGICAL

Standard Dose Quadrivalent Influenza Vaccine

Standard Dose Quadrivalent Influenza Vaccine

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • University of Wisconsin, Madison

    collaborator OTHER

  • University of Toronto

    collaborator OTHER

  • Boston VA Research Institute, Inc.

    collaborator OTHER

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • University of Minnesota

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Orly Vardeny, PharmD, MS · University of Minnesota

  • Scott D Solomon, MD · Brigham and Women's Hospital

  • KyungMann Kim, PhD · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-01
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • United States
  • Canada
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT02787044 on ClinicalTrials.gov