CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,801 enrolled
Drug / intervention
Double Dose Quadrivalent Influenza Vaccine +1 morebiological
Likely dose
Double Dose Quadrivalent Influenza Vaccine 30µgfrom 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/NCT04001504
NCT04001504Phase 3Completed

Evaluation of the Effectiveness of Double Dose Influenza Vaccination to Reduce Major Cardiovascular Events After an Acute Coronary Syndrome

Hospital Israelita Albert Einstein·interventional·Posted Jun 28, 2019·Updated Aug 31, 2022

In Brief

A Phase 3 clinical trial evaluating Double Dose Quadrivalent Influenza Vaccine and Standard Dose Quadrivalent Influenza Vaccine for Acute Coronary Syndrome. Completed, enrolled 1,801 participants across 22 sites.

Detailed Summary

Cardiovascular disease has a great burden in the context of public health, as well as the low pharmacological adherence of patients who have chronic non-transmissible diseases. However, the investigators do not have data on the efficacy of vaccination to reduce cardiovascular events in the acute coronary syndromes, and the few studies evaluating the cardioprotective potential of the influenza vaccine were conducted in countries with well defined seasonalities, divergent of Brazil, that presents a constant viral circulation during all months of the year and distinct among its regions. Therefore, study evaluating higher dose vaccination in a period that contemplates the seasonality of the influenza virus in Brazil may bring important findings to different scientific gaps, as well as clarify questions about the possible benefit of doubled vaccination - which does not present contraindications - immediately after a atherothrombotic event. If it shows real benefit, it could also be a future therapeutic tool adjuvant to traditional drug therapy in the prevention of cardiovascular events.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedJun 28, 2019
Enrollment StartJul 19, 2019
Primary CompletionAug 28, 2022
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 7.0 years ago

Interventions

Double Dose Quadrivalent Influenza Vaccinebiological

Double Dose QIV (30µg Hemagglutinin)

Standard Dose Quadrivalent Influenza Vaccinebiological

Standard Dose QIV (15µg Hemagglutinin)