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

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ClinicalTrials.gov Identifier: NCT02787044

Recruitment Status : Completed

First Posted : June 1, 2016

Results First Posted : September 14, 2021

Last Update Posted : January 21, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

National Heart, Lung, and Blood Institute (NHLBI)

University of Wisconsin, Madison

University of Toronto

Boston VA Research Institute, Inc.

Patient-Centered Outcomes Research Institute

University of Minnesota

Information provided by (Responsible Party):

Scott David Solomon, Brigham and Women's Hospital

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Conditions	Heart Failure Myocardial Infarction
Interventions	Biological: High Dose Trivalent Influenza Vaccine Biological: Standard Dose Quadrivalent Influenza Vaccine
Enrollment	5388

Participant Flow

Recruitment Details

Pre-assignment Details

A total of 5388 patients were consented for the study. Of these, 15 patients were not randomized (decided not to participate prior to randomization). 5373 patients were randomized and a total of 113 patients were excluded from all efficacy analyses prior to database lock because they had been enrolled at a site that was closed for major violations of good clinical practice, leaving 5260 participants in the efficacy and safety analysis.


Arm/Group Title	High Dose Influenza Vaccine	Standard Dose Influenza Vaccine
Arm/Group Description	High Dose Influenza Vaccine ...	Standard Dose Influenza Vaccine ...
Arm/Group Description	High Dose Influenza Vaccine High Dose Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine	Standard Dose Influenza Vaccine Standard Dose Quadrivalent Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine
Period Title: Overall Study
Started ^[1]	2630	2630
Completed	2615	2611
Not Completed	15	19
Reason Not Completed
Lost to Follow-up	15	19
[1] Total Randomized patients

Baseline Characteristics

Arm/Group Title		High Dose Influenza Vaccine	Standard Dose Influenza Vaccine	Total
Arm/Group Description		High Dose Influenza Vaccine ...	Standard Dose Influenza Vaccine ...	Total of all reporting groups
Arm/Group Description		High Dose Influenza Vaccine High Dose Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine	Standard Dose Influenza Vaccine Standard Dose Quadrivalent Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine	Total of all reporting groups
Overall Number of Baseline Participants		2630	2630	5260
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	2630 participants	2630 participants	5260 participants
		65.5 (12.6)	65.5 (12.5)	65.5 (12.5)
Sex: Female, Male ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	2621 participants	2625 participants	5246 participants
	Female	717 27.4%	756 28.8%	1473 28.1%
	Male	1904 72.6%	1869 71.2%	3773 71.9%
		[1] Measure Analysis Population Description: Some patients chose intersex or refused to answer
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	2630 participants	2630 participants	5260 participants
	Hispanic or Latino	250 9.5%	267 10.2%	517 9.8%
	Not Hispanic or Latino	2349 89.3%	2334 88.7%	4683 89.0%
	Unknown or Not Reported	31 1.2%	29 1.1%	60 1.1%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	2630 participants	2630 participants	5260 participants
	American Indian or Alaska Native	17 0.6%	32 1.2%	49 0.9%
	Asian	81 3.1%	74 2.8%	155 2.9%
	Native Hawaiian or Other Pacific Islander	13 0.5%	12 0.5%	25 0.5%
	Black or African American	407 15.5%	377 14.3%	784 14.9%
	White	2042 77.6%	2061 78.4%	4103 78.0%
	More than one race	12 0.5%	14 0.5%	26 0.5%
	Unknown or Not Reported	58 2.2%	60 2.3%	118 2.2%
Region of Enrollment Measure Type: Number Unit of measure: Participants
Canada	Number Analyzed	2630 participants	2630 participants	5260 participants
Canada		838	838	1676
United States	Number Analyzed	2630 participants	2630 participants	5260 participants
United States		1792	1792	3584
Ejection Fraction ^[1] Mean (Standard Deviation) Unit of measure: Percentage
	Number Analyzed	2275 participants	2274 participants	4549 participants
		42.5 (16.1)	41.9 (16.2)	42.2 (16.2)
		[1] Measure Analysis Population Description: Measures not available in all patients
Body Mass Index ^[1] Mean (Standard Deviation) Unit of measure: Kg/m^2
	Number Analyzed	2622 participants	2623 participants	5245 participants
		30.7 (7.2)	31.0 (7.7)	30.9 (7.4)
		[1] Measure Analysis Population Description: Not available on all patients
Qualifying Event Measure Type: Count of Participants Unit of measure: Participants
Heart Failure	Number Analyzed	2630 participants	2630 participants	5260 participants
Heart Failure		1641 62.4%	1648 62.7%	3289 62.5%
Myocardial Infarction	Number Analyzed	2630 participants	2630 participants	5260 participants
Myocardial Infarction		982 37.3%	978 37.2%	1960 37.3%
Hypertension Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	2630 participants	2630 participants	5260 participants
		1986 75.5%	2060 78.3%	4046 76.9%
Dyslipidemia Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	2630 participants	2630 participants	5260 participants
		1793 68.2%	1823 69.3%	3616 68.7%
History of Percutaneous Coronary Intervention Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	2630 participants	2630 participants	5260 participants
		1103 41.9%	1059 40.3%	2162 41.1%
Atrial Fibrillation Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	2630 participants	2630 participants	5260 participants
		854 32.5%	871 33.1%	1725 32.8%
History of Coronary Artery Bypass Graft Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	2630 participants	2630 participants	5260 participants
		503 19.1%	537 20.4%	1040 19.8%
History of Chronic Obstructive Pulmonary Disease Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	2630 participants	2630 participants	5260 participants
		486 18.5%	520 19.8%	1006 19.1%
History of Implantable Cardioverter Defibrillator Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	2630 participants	2630 participants	5260 participants
		463 17.6%	493 18.7%	956 18.2%
Asthma Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	2630 participants	2630 participants	5260 participants
		308 11.7%	294 11.2%	602 11.4%
Statins (MI group) ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	982 participants	978 participants	1960 participants
		920 93.7%	915 93.6%	1835 93.6%
		[1] Measure Analysis Population Description: Reported in MI group only
Aspirin (MI Group) ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	982 participants	978 participants	1960 participants
		907 92.4%	878 89.8%	1785 91.1%
		[1] Measure Analysis Population Description: Reported in MI group only
Beta Blocker (MI Group) ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	982 participants	978 participants	1960 participants
		839 85.4%	840 85.9%	1679 85.7%
		[1] Measure Analysis Population Description: Reported in MI group only
Diuretic (HF group) ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1641 participants	1648 participants	3289 participants
		1294 78.9%	1313 79.7%	2607 79.3%
		[1] Measure Analysis Population Description: Reported in HF group only
ACE Inhibitor/ Angiotensin Receptor Blocker / Angiotensin Receptor Neprilysin Inhibitor ^[1] [2] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1641 participants	1648 participants	3289 participants
		1086 66.2%	1111 67.4%	2197 66.8%
		[1] Measure Description: ACE = Angiotensin Converting Enzyme [2] Measure Analysis Population Description: Reported in HF group only
Mineralocorticoid Receptor Antagonist (MRA) (HF group) ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1641 participants	1648 participants	3289 participants
		572 34.9%	546 33.1%	1118 34.0%
		[1] Measure Analysis Population Description: Reported in HF group only
Digoxin (HF Group) ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1641 participants	1648 participants	3289 participants
		155 9.4%	159 9.6%	314 9.5%
		[1] Measure Analysis Population Description: Reporte in HF group only
Beta Blocker (HF Group) ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1641 participants	1648 participants	3289 participants
		1381 84.2%	1398 84.8%	2779 84.5%
		[1] Measure Analysis Population Description: Reported in HF group only

Outcome Measures

1.Primary Outcome


Title	All-Cause Death or Cardiopulmonary Hospitalization Within Each Vaccination Season
Description	Number of patients with first occurrence of death or cardiopulmonary h...
Description	Number of patients with first occurrence of death or cardiopulmonary hospitalization within each vaccination season
Time Frame	Up to 1 year from vaccination (repeats seasonally)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	High Dose Influenza Vaccine	Standard Dose Influenza Vaccine
Arm/Group Description:	High Dose Influenza Vaccine ...	Standard Dose Influenza Vaccine ...
Arm/Group Description:	High Dose Influenza Vaccine High Dose Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine; Note primary analysis is of participant-seasons (n = 3577)	Standard Dose Influenza Vaccine Standard Dose Quadrivalent Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine; Note primary analysis is of participant-seasons (n = 3577)
Overall Number of Participants Analyzed	2630	2630
Overall Number of Units Analyzed Type of Units Analyzed: Participant-Seasons	3577	3577
Count of Units Unit of Measure: Participant-Seasons
	975 27.3%	924 25.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	High Dose Influenza Vaccine, Standard Dose Influenza Vaccine
	Comments	Note, each participant can be included in the primary analysis up to 3 times (participating seasons).
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.21
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95% 0.97 to 1.17
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Total Cardiopulmonary Hospitalizations or Death
Description	Total (first and recurrent) cardiopulmonary hospitalizations or death
Description	Total (first and recurrent) cardiopulmonary hospitalizations or death
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	High Dose Influenza Vaccine	Standard Dose Influenza Vaccine
Arm/Group Description:	High Dose Influenza Vaccine ...	Standard Dose Influenza Vaccine ...
Arm/Group Description:	High Dose Influenza Vaccine High Dose Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine	Standard Dose Influenza Vaccine Standard Dose Quadrivalent Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine
Overall Number of Participants Analyzed	2630	2630
Measure Type: Number Unit of Measure: All CP hospitalizations/death
	1857	1784

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	High Dose Influenza Vaccine, Standard Dose Influenza Vaccine
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.44
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95% 0.94 to 1.15
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Cardiovascular Death or Hospitalization Within Each Vaccination Season
Description	Number of patients with first cardiovascular death or cardiovascular h...
Description	Number of patients with first cardiovascular death or cardiovascular hospitalization within each influenza season
Time Frame	Up to one year from vaccination

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	High Dose Influenza Vaccine	Standard Dose Influenza Vaccine
Arm/Group Description:	High Dose Influenza Vaccine ...	Standard Dose Influenza Vaccine ...
Arm/Group Description:	High Dose Influenza Vaccine High Dose Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine; Note: primary analysis is of participant-seasons (n = 3577)	Standard Dose Influenza Vaccine Standard Dose Quadrivalent Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine; Note: primary analysis is of participant-seasons (n = 3577)
Overall Number of Participants Analyzed	2630	2630
Overall Number of Units Analyzed Type of Units Analyzed: Participant-Seasons	3577	3577
Count of Units Unit of Measure: Participant-Seasons
	805 22.5%	752 21.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	High Dose Influenza Vaccine, Standard Dose Influenza Vaccine
	Comments	Each participant can be analyzed up to three times (seasons)
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.16
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 95% .97 to 1.2
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Death or Cardiopulmonary Hospitalization Across Enrolling Seasons
Description	First cardiopulmonary Hospitalization or all-cause death across enroll...
Description	First cardiopulmonary Hospitalization or all-cause death across enrolling seasons
Time Frame	Up to three years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	High Dose Influenza Vaccine	Standard Dose Influenza Vaccine
Arm/Group Description:	High Dose Influenza Vaccine ...	Standard Dose Influenza Vaccine ...
Arm/Group Description:	High Dose Influenza Vaccine High Dose Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine	Standard Dose Influenza Vaccine Standard Dose Quadrivalent Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine
Overall Number of Participants Analyzed	2630	2630
Measure Type: Number Unit of Measure: first CP hospitalization/death
	955	918

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	High Dose Influenza Vaccine, Standard Dose Influenza Vaccine
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.26
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95% .96 to 1.15
	Estimation Comments	[Not Specified]

5.Secondary Outcome


Title	All-Cause Mortality
Description	Number of patients with first occurrence of all-cause mortality
Description	Number of patients with first occurrence of all-cause mortality
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	High Dose Influenza Vaccine	Standard Dose Influenza Vaccine
Arm/Group Description:	High Dose Influenza Vaccine ...	Standard Dose Influenza Vaccine ...
Arm/Group Description:	High Dose Influenza Vaccine High Dose Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine	Standard Dose Influenza Vaccine Standard Dose Quadrivalent Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine
Overall Number of Participants Analyzed	2630	2630
Measure Type: Number Unit of Measure: All cause deaths
	223	222

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	High Dose Influenza Vaccine, Standard Dose Influenza Vaccine
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.96
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95% 0.84 to 1.21
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events
Adverse Event Reporting Description	Post-vaccination AEs were collected via participant self report up to 1 week post vaccination. Potential SAEs during study participation were reviewed by study monitors. For all-cause mortality, the number of patients at risk are the total number of patients randomized who were included in the efficacy analyses: 2630 per group. For all other adverse events, the safety analysis set consists of patients who received study vaccination (2606 in high-dose group and 2604 in standard-dose group).

Arm/Group Title	High Dose Influenza Vaccine		Standard Dose Influenza Vaccine
Arm/Group Description	High Dose Influenza Vaccine ...		Standard Dose Influenza Vaccine ...
Arm/Group Description	High Dose Influenza Vaccine High Dose Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine		Standard Dose Influenza Vaccine Standard Dose Quadrivalent Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine
All-Cause Mortality
	High Dose Influenza Vaccine		Standard Dose Influenza Vaccine
	Affected / at Risk (%)		Affected / at Risk (%)
Total	223/2630 (8.48%)		222/2630 (8.44%)
Serious Adverse Events Serious Adverse Events
	High Dose Influenza Vaccine		Standard Dose Influenza Vaccine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/2606 (0.08%)		4/2604 (0.15%)
Cardiac disorders
Cardiac Arrest ^†	1/2606 (0.04%)	1	0/2604 (0.00%)	0
Gastrointestinal disorders
Dysgusia ^†	0/2606 (0.00%)	0	1/2604 (0.04%)	1
General disorders
Fever ^†	1/2606 (0.04%)	1	0/2604 (0.00%)	0
Nervous system disorders
Bell's Palsy ^†	0/2606 (0.00%)	0	1/2604 (0.04%)	1
Neuritis ^†	0/2606 (0.00%)	0	1/2604 (0.04%)	1
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure ^†	0/2606 (0.00%)	0	1/2604 (0.04%)	1
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	High Dose Influenza Vaccine		Standard Dose Influenza Vaccine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1241/2606 (47.62%)		1096/2604 (42.09%)
General disorders
Myalgia ^†	447/2606 (17.15%)	500	391/2604 (15.02%)	423
Overall Discomfort ^†	290/2606 (11.13%)	310	266/2604 (10.22%)	280
Headache ^†	265/2606 (10.17%)	279	253/2604 (9.72%)	272
Injury, poisoning and procedural complications
Pain at injection site ^†	788/2606 (30.24%)	932	594/2604 (22.81%)	683
Swelling ^†	179/2606 (6.87%)	198	115/2604 (4.42%)	119
Erythema ^†	144/2606 (5.53%)	157	150/2604 (5.76%)	157
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Dr. Scott Solomon
Organization:	Brigham and Women's Hospital
Phone:	857-307-1960
EMail:	ssolomon@bwh.harvard.edu

Publications of Results:

Vardeny O, Kim K, Udell JA, Joseph J, Desai AS, Farkouh ME, Hegde SM, Hernandez AF, McGeer A, Talbot HK, Anand I, Bhatt DL, Cannon CP, DeMets D, Gaziano JM, Goodman SG, Nichol K, Tattersall MC, Temte JL, Wittes J, Yancy C, Claggett B, Chen Y, Mao L, Havighurst TC, Cooper LS, Solomon SD; INVESTED Committees and Investigators. Effect of High-Dose Trivalent vs Standard-Dose Quadrivalent Influenza Vaccine on Mortality or Cardiopulmonary Hospitalization in Patients With High-risk Cardiovascular Disease: A Randomized Clinical Trial. JAMA. 2021 Jan 5;325(1):39-49. doi: 10.1001/jama.2020.23649.

Other Publications:

Vardeny O, Sweitzer NK, Detry MA, Moran JM, Johnson MR, Hayney MS. Decreased immune responses to influenza vaccination in patients with heart failure. J Card Fail. 2009 May;15(4):368-73. doi: 10.1016/j.cardfail.2008.11.009. Epub 2008 Dec 18.

Vardeny O, Moran JJ, Sweitzer NK, Johnson MR, Hayney MS. Decreased T-cell responses to influenza vaccination in patients with heart failure. Pharmacotherapy. 2010 Jan;30(1):10-6. doi: 10.1592/phco.30.1.10.

Van Ermen A, Hermanson MP, Moran JM, Sweitzer NK, Johnson MR, Vardeny O. Double dose vs. standard dose influenza vaccination in patients with heart failure: a pilot study. Eur J Heart Fail. 2013 May;15(5):560-4. doi: 10.1093/eurjhf/hfs207. Epub 2013 Jan 4.

Albrecht CM, Sweitzer NK, Johnson MR, Vardeny O. Lack of persistence of influenza vaccine antibody titers in patients with heart failure. J Card Fail. 2014 Feb;20(2):105-9. doi: 10.1016/j.cardfail.2013.12.008. Epub 2013 Dec 19.

Udell JA, Farkouh ME, Solomon SD, Vardeny O. Does influenza vaccination influence cardiovascular complications? Expert Rev Cardiovasc Ther. 2015 Jun;13(6):593-6. doi: 10.1586/14779072.2015.1044439. Epub 2015 May 14.

Vardeny O, Claggett B, Udell JA, Packer M, Zile M, Rouleau J, Swedberg K, Desai AS, Lefkowitz M, Shi V, McMurray JJV, Solomon SD; PARADIGM-HF Investigators. Influenza Vaccination in Patients With Chronic Heart Failure: The PARADIGM-HF Trial. JACC Heart Fail. 2016 Feb;4(2):152-158. doi: 10.1016/j.jchf.2015.10.012. Epub 2015 Dec 30.

Udell JA, Zawi R, Bhatt DL, Keshtkar-Jahromi M, Gaughran F, Phrommintikul A, Ciszewski A, Vakili H, Hoffman EB, Farkouh ME, Cannon CP. Association between influenza vaccination and cardiovascular outcomes in high-risk patients: a meta-analysis. JAMA. 2013 Oct 23;310(16):1711-20. doi: 10.1001/jama.2013.279206.

Vardeny O, Udell JA, Joseph J, Farkouh ME, Hernandez AF, McGeer AJ, Talbot HK, Bhatt DL, Cannon CP, Goodman SG, Anand I, DeMets DL, Temte J, Wittes J, Nichol K, Yancy CW, Gaziano JM, Cooper LS, Kim K, Solomon SD. High-dose influenza vaccine to reduce clinical outcomes in high-risk cardiovascular patients: Rationale and design of the INVESTED trial. Am Heart J. 2018 Aug;202:97-103. doi: 10.1016/j.ahj.2018.05.007. Epub 2018 May 23.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Vardeny O, Hernandez AF, Cohen LW, Franklin A, Baqai M, Palmer S, Bierer BE, Cobb N. Transitioning to the National Institutes of Health single institutional review board model: Piloting the use of the Streamlined, Multi-site, Accelerated Resources for Trials IRB Reliance. Clin Trials. 2019 Jun;16(3):290-296. doi: 10.1177/1740774519832911. Epub 2019 Mar 13.

Layout table for additonal information

Responsible Party:	Scott David Solomon, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT02787044
Other Study ID Numbers:	2015P001823 U01HL130163 ( U.S. NIH Grant/Contract )
First Submitted:	May 25, 2016
First Posted:	June 1, 2016
Results First Submitted:	May 24, 2021
Results First Posted:	September 14, 2021
Last Update Posted:	January 21, 2022

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