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Influenza Vaccine To Prevent Adverse Vascular Events:Pilot

NCT01945268 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 107

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. 600 participants will be enrolled prior to influenza season and randomized to either influenza vaccine or saline placebo.

Conditions

Interventions

DRUG

inactivated trivalent influenza vaccine

0.5 ml dose injected intramuscularly

OTHER

Sterile saline

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
2015-04-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Mozambique
  • Philippines
  • Uganda

Study Locations

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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 NCT01945268 on ClinicalTrials.gov