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COMPLETED Phase 4

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

NCT02787044 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • BIOLOGICAL High Dose Trivalent Influenza Vaccine
  • BIOLOGICAL Standard Dose Quadrivalent Influenza Vaccine

Study Locations (20)

Florida

  • Clearwater Cardiovascular Consultants — Clearwater
  • N FL/S GA Veterans Health System — Gainesville
  • OneFlorida CDRN — Gainesville
  • Clearwater Cardiovascular Consultants-Largo — Largo
  • Inpatient Research Corporation — Miami
  • ITB Research — Miami

California

  • VA Loma Linda Healthcare System — Loma Linda
  • Long Beach VAMC — Long Beach
  • University of California Davis Medical Center — Sacramento
  • VA San Diego Healthcare System — San Diego
  • UCSF Medical Center — San Francisco

Alabama

  • Birmingham VAMC — Birmingham
  • University of Alabama Hypertension Program — Birmingham
  • Heart Center Research, LLC — Huntsville

Arizona

  • Banner University Medicine North — Tucson
  • University of Arizona- Sarver Heart Center — Tucson

Alaska

  • Alaska Heart & Vascular Institute — Anchorage

Arkansas

  • CAVHS — Little Rock

Connecticut

  • VA West Haven — West Haven

District of Columbia

  • Washington DC VAMC — Washington D.C.

Trial Details

FieldValue
Enrollment Target 5,388 participants
Start Date 2016-08-01
Est. Completion 2020-05-31
Phase Phase 4

Sponsor

Brigham and Women's Hospital

929 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02787044

The ClinicalTrials.gov registry entry for NCT02787044 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 5,388 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 929 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions — of which High Dose Trivalent Influenza Vaccine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02787044 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02787044 about?

NCT02787044 is a clinical study titled "INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure". 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 e...

What is the current status of trial NCT02787044?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 5,388 participants. The study started on 2016-08-01. Estimated completion is 2020-05-31.

What conditions does trial NCT02787044 study?

This clinical trial studies the following conditions: Heart Failure, Myocardial Infarction. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02787044?

The interventions under investigation include: High Dose Trivalent Influenza Vaccine (BIOLOGICAL), Standard Dose Quadrivalent Influenza Vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02787044?

This trial is sponsored by Brigham and Women's Hospital, which has 929 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02787044 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial