CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 5,388 enrolled
Drug / intervention
High Dose Trivalent Influenza Vaccine +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02787044
NCT02787044Phase 4Completed
CompareCT.gov

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

Brigham and Women's Hospital·interventional·Posted Jun 1, 2016·Updated Jan 21, 2022

In Brief

A Phase 4 clinical trial evaluating High Dose Trivalent Influenza Vaccine and Standard Dose Quadrivalent Influenza Vaccine for Heart Failure and Myocardial Infarction. Completed, enrolled 5,388 participants across 190 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Myocardial Infarction
CountriesCanada, Puerto Rico, United States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), University of Wisconsin, Madison, University of Toronto, Boston VA Research Institute, Inc., Patient-Centered Outcomes Research Institute, University of Minnesota

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 1, 2016
Enrollment StartAug 1, 2016
Primary CompletionMay 31, 2020
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 10.1 years ago

Interventions

High Dose Trivalent Influenza Vaccinebiological

High Dose Trivalent Influenza Vaccine

Standard Dose Quadrivalent Influenza Vaccinebiological

Standard Dose Quadrivalent Influenza Vaccine