Trial · NCT02787044

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

NCT02787044, Phase 4, Completed, Brigham and Women's Hospital; results first posted 2021-09-14

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure. Trials, record NCT02787044. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02787044

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure
NCT number: NCT02787044
Status: Completed
Phases: Phase 4
Enrollment: 5,388 participants, actual
Lead sponsor: Brigham and Women's Hospital
Conditions: Heart Failure, Myocardial Infarction
Interventions: High Dose Trivalent Influenza Vaccine, Standard Dose Quadrivalent Influenza Vaccine
First posted: 2016-06-01
Last updated: 2022-01-21
Results first posted: 2021-09-14

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	All-Cause Death or Cardiopulmonary Hospitalization Within Each Vaccination Season	Up to 1 year from vaccination (repeats seasonally)	Number of patients with first occurrence of death or cardiopulmonary hospitalization within each vaccination season
Secondary	Total Cardiopulmonary Hospitalizations or Death	Up to 3 years	Total (first and recurrent) cardiopulmonary hospitalizations or death
Secondary	Cardiovascular Death or Hospitalization Within Each Vaccination Season	Up to one year from vaccination	Number of patients with first cardiovascular death or cardiovascular hospitalization within each influenza season
Secondary	Death or Cardiopulmonary Hospitalization Across Enrolling Seasons	Up to three years	First cardiopulmonary Hospitalization or all-cause death across enrolling seasons
Secondary	All-Cause Mortality	Up to 3 years	Number of patients with first occurrence of all-cause mortality

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	All-Cause Death or Cardiopulmonary Hospitalization Within Each Vaccination Season	Up to 1 year from vaccination (repeats seasonally)	Participant-Seasons	COUNT_OF_UNITS
SECONDARY	Total Cardiopulmonary Hospitalizations or Death	Up to 3 years	All CP hospitalizations/death	NUMBER
SECONDARY	Cardiovascular Death or Hospitalization Within Each Vaccination Season	Up to one year from vaccination	Participant-Seasons	COUNT_OF_UNITS
SECONDARY	Death or Cardiopulmonary Hospitalization Across Enrolling Seasons	Up to three years	first CP hospitalization/death	NUMBER
SECONDARY	All-Cause Mortality	Up to 3 years	All cause deaths	NUMBER

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
All-Cause Death or Cardiopulmonary Hospitalization Within Each Vaccination Season	High Dose Influenza Vaccine	975	Participant-Seasons
All-Cause Death or Cardiopulmonary Hospitalization Within Each Vaccination Season	Standard Dose Influenza Vaccine	924	Participant-Seasons
Total Cardiopulmonary Hospitalizations or Death	High Dose Influenza Vaccine	1857	All CP hospitalizations/death
Total Cardiopulmonary Hospitalizations or Death	Standard Dose Influenza Vaccine	1784	All CP hospitalizations/death
Cardiovascular Death or Hospitalization Within Each Vaccination Season	High Dose Influenza Vaccine	805	Participant-Seasons
Cardiovascular Death or Hospitalization Within Each Vaccination Season	Standard Dose Influenza Vaccine	752	Participant-Seasons
Death or Cardiopulmonary Hospitalization Across Enrolling Seasons	High Dose Influenza Vaccine	955	first CP hospitalization/death
Death or Cardiopulmonary Hospitalization Across Enrolling Seasons	Standard Dose Influenza Vaccine	918	first CP hospitalization/death
All-Cause Mortality	High Dose Influenza Vaccine	223	All cause deaths
All-Cause Mortality	Standard Dose Influenza Vaccine	222	All cause deaths

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	High Dose Influenza Vaccine	2,630
Overall Study	STARTED	Standard Dose Influenza Vaccine	2,630
Overall Study	COMPLETED	High Dose Influenza Vaccine	2,615
Overall Study	COMPLETED	Standard Dose Influenza Vaccine	2,611
Overall Study	NOT COMPLETED	High Dose Influenza Vaccine	15
Overall Study	NOT COMPLETED	Standard Dose Influenza Vaccine	19

Source ClinicalTrials.gov

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Pain at injection site	Injury, poisoning and procedural complications	High Dose Influenza Vaccine	788	2,606	932
other	Pain at injection site	Injury, poisoning and procedural complications	Standard Dose Influenza Vaccine	594	2,604	683
other	Myalgia	General disorders	High Dose Influenza Vaccine	447	2,606	500
other	Myalgia	General disorders	Standard Dose Influenza Vaccine	391	2,604	423
other	Overall Discomfort	General disorders	High Dose Influenza Vaccine	290	2,606	310
other	Overall Discomfort	General disorders	Standard Dose Influenza Vaccine	266	2,604	280
other	Headache	General disorders	High Dose Influenza Vaccine	265	2,606	279
other	Headache	General disorders	Standard Dose Influenza Vaccine	253	2,604	272
other	Swelling	Injury, poisoning and procedural complications	High Dose Influenza Vaccine	179	2,606	198
other	Swelling	Injury, poisoning and procedural complications	Standard Dose Influenza Vaccine	115	2,604	119

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	High Dose Influenza Vaccine	223	2,630
Total, all-cause mortality	Standard Dose Influenza Vaccine	222	2,630
Total, other adverse events	High Dose Influenza Vaccine	1,241	2,606
Total, other adverse events	Standard Dose Influenza Vaccine	1,096	2,604
Total, serious adverse events	High Dose Influenza Vaccine	2	2,606
Total, serious adverse events	Standard Dose Influenza Vaccine	4	2,604

Source ClinicalTrials.gov

Papers14

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19398087	BACKGROUND	PubMed
20030468	BACKGROUND	PubMed
23291729	BACKGROUND	PubMed
24150467	BACKGROUND	PubMed
24361852	BACKGROUND	PubMed
25971953	BACKGROUND	PubMed
26746371	BACKGROUND	PubMed
29909156	BACKGROUND	PubMed
30866676	DERIVED	PubMed
33275134	RESULT	PubMed

1 to 10 of 14

See all 14 papers

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01HL130163	INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure (INVESTED)	SOLOMON, SCOTT DAVID; VARDENY, ORLY	BRIGHAM AND WOMEN'S HOSPITAL	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2016 to 2019

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
High Dose Influenza Vaccine vs Standard Dose Influenza Vaccine: deaths from any cause	Trial comparisons
High Dose Influenza Vaccine vs Standard Dose Influenza Vaccine: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02787044

GET https://conductscience.org/api/trials/v1/NCT02787044/events?page=2

API reference For AI assistants