Trial Outcomes & Findings for INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure (NCT NCT02787044)

NCT ID: NCT02787044

Last Updated: 2022-01-21

Results Overview

Number of patients with first occurrence of death or cardiopulmonary hospitalization within each vaccination season

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 5388 participants
• Primary outcome timeframe: Up to 1 year from vaccination (repeats seasonally)
• Results posted on: 2022-01-21

Participant Flow

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.

Participant milestones

Measure	High Dose Influenza Vaccine High Dose Influenza Vaccine High Dose Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine	Standard Dose Influenza Vaccine Standard Dose Influenza Vaccine Standard Dose Quadrivalent Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine
Overall Study STARTED	2630	2630
Overall Study COMPLETED	2615	2611
Overall Study NOT COMPLETED	15	19

Reasons for withdrawal

Measure	High Dose Influenza Vaccine High Dose Influenza Vaccine High Dose Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine	Standard Dose Influenza Vaccine Standard Dose Influenza Vaccine Standard Dose Quadrivalent Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine
Overall Study Lost to Follow-up	15	19

Baseline Characteristics

Some patients chose intersex or refused to answer

Baseline characteristics by cohort

Measure	High Dose Influenza Vaccine n=2630 Participants High Dose Influenza Vaccine High Dose Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine	Standard Dose Influenza Vaccine n=2630 Participants Standard Dose Influenza Vaccine Standard Dose Quadrivalent Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine	Total n=5260 Participants Total of all reporting groups
Age, Continuous	65.5 years STANDARD_DEVIATION 12.6 • n=2630 Participants	65.5 years STANDARD_DEVIATION 12.5 • n=2630 Participants	65.5 years STANDARD_DEVIATION 12.5 • n=5260 Participants
Sex: Female, Male Female	717 Participants n=2621 Participants • Some patients chose intersex or refused to answer	756 Participants n=2625 Participants • Some patients chose intersex or refused to answer	1473 Participants n=5246 Participants • Some patients chose intersex or refused to answer
Sex: Female, Male Male	1904 Participants n=2621 Participants • Some patients chose intersex or refused to answer	1869 Participants n=2625 Participants • Some patients chose intersex or refused to answer	3773 Participants n=5246 Participants • Some patients chose intersex or refused to answer
Ethnicity (NIH/OMB) Hispanic or Latino	250 Participants n=2630 Participants	267 Participants n=2630 Participants	517 Participants n=5260 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2349 Participants n=2630 Participants	2334 Participants n=2630 Participants	4683 Participants n=5260 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	31 Participants n=2630 Participants	29 Participants n=2630 Participants	60 Participants n=5260 Participants
Race (NIH/OMB) American Indian or Alaska Native	17 Participants n=2630 Participants	32 Participants n=2630 Participants	49 Participants n=5260 Participants
Race (NIH/OMB) Asian	81 Participants n=2630 Participants	74 Participants n=2630 Participants	155 Participants n=5260 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	13 Participants n=2630 Participants	12 Participants n=2630 Participants	25 Participants n=5260 Participants
Race (NIH/OMB) Black or African American	407 Participants n=2630 Participants	377 Participants n=2630 Participants	784 Participants n=5260 Participants
Race (NIH/OMB) White	2042 Participants n=2630 Participants	2061 Participants n=2630 Participants	4103 Participants n=5260 Participants
Race (NIH/OMB) More than one race	12 Participants n=2630 Participants	14 Participants n=2630 Participants	26 Participants n=5260 Participants
Race (NIH/OMB) Unknown or Not Reported	58 Participants n=2630 Participants	60 Participants n=2630 Participants	118 Participants n=5260 Participants
Region of Enrollment Canada	838 participants n=2630 Participants	838 participants n=2630 Participants	1676 participants n=5260 Participants
Region of Enrollment United States	1792 participants n=2630 Participants	1792 participants n=2630 Participants	3584 participants n=5260 Participants
Ejection Fraction	42.5 Percentage STANDARD_DEVIATION 16.1 • n=2275 Participants • Measures not available in all patients	41.9 Percentage STANDARD_DEVIATION 16.2 • n=2274 Participants • Measures not available in all patients	42.2 Percentage STANDARD_DEVIATION 16.2 • n=4549 Participants • Measures not available in all patients
Body Mass Index	30.7 kg/m^2 STANDARD_DEVIATION 7.2 • n=2622 Participants • Not available on all patients	31.0 kg/m^2 STANDARD_DEVIATION 7.7 • n=2623 Participants • Not available on all patients	30.9 kg/m^2 STANDARD_DEVIATION 7.4 • n=5245 Participants • Not available on all patients
Qualifying Event Heart Failure	1641 Participants n=2630 Participants	1648 Participants n=2630 Participants	3289 Participants n=5260 Participants
Qualifying Event Myocardial Infarction	982 Participants n=2630 Participants	978 Participants n=2630 Participants	1960 Participants n=5260 Participants
Hypertension	1986 Participants n=2630 Participants	2060 Participants n=2630 Participants	4046 Participants n=5260 Participants
Dyslipidemia	1793 Participants n=2630 Participants	1823 Participants n=2630 Participants	3616 Participants n=5260 Participants
History of Percutaneous Coronary Intervention	1103 Participants n=2630 Participants	1059 Participants n=2630 Participants	2162 Participants n=5260 Participants
Atrial Fibrillation	854 Participants n=2630 Participants	871 Participants n=2630 Participants	1725 Participants n=5260 Participants
History of Coronary Artery Bypass Graft	503 Participants n=2630 Participants	537 Participants n=2630 Participants	1040 Participants n=5260 Participants
History of Chronic Obstructive Pulmonary Disease	486 Participants n=2630 Participants	520 Participants n=2630 Participants	1006 Participants n=5260 Participants
History of Implantable Cardioverter Defibrillator	463 Participants n=2630 Participants	493 Participants n=2630 Participants	956 Participants n=5260 Participants
Asthma	308 Participants n=2630 Participants	294 Participants n=2630 Participants	602 Participants n=5260 Participants
Statins (MI group)	920 Participants n=982 Participants • Reported in MI group only	915 Participants n=978 Participants • Reported in MI group only	1835 Participants n=1960 Participants • Reported in MI group only
Aspirin (MI Group)	907 Participants n=982 Participants • Reported in MI group only	878 Participants n=978 Participants • Reported in MI group only	1785 Participants n=1960 Participants • Reported in MI group only
Beta Blocker (MI Group)	839 Participants n=982 Participants • Reported in MI group only	840 Participants n=978 Participants • Reported in MI group only	1679 Participants n=1960 Participants • Reported in MI group only
Diuretic (HF group)	1294 Participants n=1641 Participants • Reported in HF group only	1313 Participants n=1648 Participants • Reported in HF group only	2607 Participants n=3289 Participants • Reported in HF group only
ACE Inhibitor/ Angiotensin Receptor Blocker / Angiotensin Receptor Neprilysin Inhibitor	1086 Participants n=1641 Participants • Reported in HF group only	1111 Participants n=1648 Participants • Reported in HF group only	2197 Participants n=3289 Participants • Reported in HF group only
Mineralocorticoid Receptor Antagonist (MRA) (HF group)	572 Participants n=1641 Participants • Reported in HF group only	546 Participants n=1648 Participants • Reported in HF group only	1118 Participants n=3289 Participants • Reported in HF group only
Digoxin (HF Group)	155 Participants n=1641 Participants • Reporte in HF group only	159 Participants n=1648 Participants • Reporte in HF group only	314 Participants n=3289 Participants • Reporte in HF group only
Beta Blocker (HF Group)	1381 Participants n=1641 Participants • Reported in HF group only	1398 Participants n=1648 Participants • Reported in HF group only	2779 Participants n=3289 Participants • Reported in HF group only

PRIMARY outcome

Timeframe: Up to 1 year from vaccination (repeats seasonally)

Number of patients with first occurrence of death or cardiopulmonary hospitalization within each vaccination season

Outcome measures

Measure	High Dose Influenza Vaccine n=3577 Participant-Seasons 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 n=3577 Participant-Seasons Standard Dose Influenza Vaccine Standard Dose Quadrivalent Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine; Note primary analysis is of participant-seasons (n = 3577)
All-Cause Death or Cardiopulmonary Hospitalization Within Each Vaccination Season	975 Participant-Seasons	924 Participant-Seasons

SECONDARY outcome

Timeframe: Up to 3 years

Total (first and recurrent) cardiopulmonary hospitalizations or death

Outcome measures

Measure	High Dose Influenza Vaccine n=2630 Participants 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 n=2630 Participants Standard Dose Influenza Vaccine Standard Dose Quadrivalent Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine; Note primary analysis is of participant-seasons (n = 3577)
Total Cardiopulmonary Hospitalizations or Death	1857 All CP hospitalizations/death	1784 All CP hospitalizations/death

SECONDARY outcome

Timeframe: Up to one year from vaccination

Number of patients with first cardiovascular death or cardiovascular hospitalization within each influenza season

Outcome measures

Measure	High Dose Influenza Vaccine n=3577 Participant-Seasons 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 n=3577 Participant-Seasons Standard Dose Influenza Vaccine Standard Dose Quadrivalent Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine; Note primary analysis is of participant-seasons (n = 3577)
Cardiovascular Death or Hospitalization Within Each Vaccination Season	805 Participant-Seasons	752 Participant-Seasons

SECONDARY outcome

Timeframe: Up to three years

First cardiopulmonary Hospitalization or all-cause death across enrolling seasons

Outcome measures

Measure	High Dose Influenza Vaccine n=2630 Participants 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 n=2630 Participants Standard Dose Influenza Vaccine Standard Dose Quadrivalent Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine; Note primary analysis is of participant-seasons (n = 3577)
Death or Cardiopulmonary Hospitalization Across Enrolling Seasons	955 first CP hospitalization/death	918 first CP hospitalization/death

SECONDARY outcome

Timeframe: Up to 3 years

Number of patients with first occurrence of all-cause mortality

Outcome measures

Measure	High Dose Influenza Vaccine n=2630 Participants 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 n=2630 Participants Standard Dose Influenza Vaccine Standard Dose Quadrivalent Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine; Note primary analysis is of participant-seasons (n = 3577)
All-Cause Mortality	223 All cause deaths	222 All cause deaths

Adverse Events

High Dose Influenza Vaccine

Serious events: 2 serious events

Other events: 1241 other events

Deaths: 223 deaths

Standard Dose Influenza Vaccine

Serious events: 4 serious events

Other events: 1096 other events

Deaths: 222 deaths

Serious adverse events

Measure	High Dose Influenza Vaccine n=2606 participants at risk High Dose Influenza Vaccine High Dose Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine	Standard Dose Influenza Vaccine n=2604 participants at risk Standard Dose Influenza Vaccine Standard Dose Quadrivalent Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine
Nervous system disorders Bell's Palsy	0.00% 0/2606 • 1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events 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).	0.04% 1/2604 • Number of events 1 • 1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events 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).
Nervous system disorders Neuritis	0.00% 0/2606 • 1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events 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).	0.04% 1/2604 • Number of events 1 • 1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events 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).
General disorders Fever	0.04% 1/2606 • Number of events 1 • 1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events 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).	0.00% 0/2604 • 1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events 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).
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/2606 • 1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events 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).	0.04% 1/2604 • Number of events 1 • 1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events 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).
Gastrointestinal disorders Dysgusia	0.00% 0/2606 • 1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events 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).	0.04% 1/2604 • Number of events 1 • 1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events 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).
Cardiac disorders Cardiac Arrest	0.04% 1/2606 • Number of events 1 • 1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events 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).	0.00% 0/2604 • 1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events 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).

Other adverse events

Measure	High Dose Influenza Vaccine n=2606 participants at risk High Dose Influenza Vaccine High Dose Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine	Standard Dose Influenza Vaccine n=2604 participants at risk Standard Dose Influenza Vaccine Standard Dose Quadrivalent Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine
Injury, poisoning and procedural complications Swelling	6.9% 179/2606 • Number of events 198 • 1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events 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).	4.4% 115/2604 • Number of events 119 • 1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events 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).
Injury, poisoning and procedural complications Pain at injection site	30.2% 788/2606 • Number of events 932 • 1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events 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).	22.8% 594/2604 • Number of events 683 • 1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events 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).
General disorders Myalgia	17.2% 447/2606 • Number of events 500 • 1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events 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).	15.0% 391/2604 • Number of events 423 • 1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events 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).
General disorders Overall Discomfort	11.1% 290/2606 • Number of events 310 • 1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events 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).	10.2% 266/2604 • Number of events 280 • 1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events 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).
General disorders Headache	10.2% 265/2606 • Number of events 279 • 1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events 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).	9.7% 253/2604 • Number of events 272 • 1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events 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).
Injury, poisoning and procedural complications Erythema	5.5% 144/2606 • Number of events 157 • 1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events 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).	5.8% 150/2604 • Number of events 157 • 1 week for post-vaccination adverse events; 1-3 years, depending on length of participation for serious adverse events 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).

Additional Information

Dr. Scott Solomon

Brigham and Women's Hospital

Phone: 857-307-1960

Email: ssolomon@bwh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place