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Influenza Vaccine To Prevent Adverse Vascular Events (RCT-IVVE)

NCT02762851 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5000

Last updated 2018-10-26

No results posted yet for this study

Summary

A multi-centre, randomized, placebo controlled, trial. Participants at high-risk for vascular events from the network of INTER- CHF will be randomized to inactivated influenza vaccine or placebo and followed prospectively over three influenza seasons. 5,000 participants will be enrolled prior to influenza season, randomized to either influenza vaccine or saline placebo, either of which they will receive annually for three years and then followed over each of the influenza seasons.

Conditions

Interventions

OTHER

Sterile saline

0.5 ml dose injected intramuscularly

DRUG

inactivated trivalent influenza vaccine

0.5 ml dose injected intramuscularly

Sponsors & Collaborators

Principal Investigators

  • Mark Loeb, MD, MSc. · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2019-12-31
Completion
2020-12-31

Countries

  • Cameroon
  • China
  • India
  • Kenya
  • Lebanon
  • Mozambique
  • Nigeria
  • Philippines
  • Saudi Arabia
  • Sudan
  • Uganda
  • United Arab Emirates
  • Zambia

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 NCT02762851 on ClinicalTrials.gov