At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 107 enrolled
Drug / intervention
inactivated trivalent influenza vaccine +1 moredrug
Likely dose
inactivated trivalent influenza vaccine 0.5 mlfrom 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.
A Randomized Controlled Trial of Influenza Vaccine to Prevent Adverse Vascular Events: A Pilot Study
In Brief
A Phase 4 clinical trial evaluating inactivated trivalent influenza vaccine and Sterile saline for Heart Failure. Completed, enrolled 107 participants across 3 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesMozambique, Philippines, Uganda
CollaboratorsPopulation Health Research Institute
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 2013
Enrollment StartApr 2015
Primary CompletionDec 2015
TodayJul 2026
First PostedSep 18, 2013
Enrollment StartApr 1, 2015
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 12.8 years ago
Interventions
inactivated trivalent influenza vaccinedrug
0.5 ml dose injected intramuscularly
Sterile salineother
0.5 ml dose injected intramuscularly