Trial Outcomes & Findings for A Pivotal Trial to Assess the Safety and Clinical Efficacy of the M-001 as a Standalone Universal Flu Vaccine (NCT NCT03450915)
NCT ID: NCT03450915
Last Updated: 2021-10-05
Results Overview
Prevention of influenza disease by comparing the occurrence of either qRT-PCR or culture confirmed influenza in the M-001 experimental group vs. placebo caused by any influenza A or B virus in association with a protocol defined Influenza Like Illness.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
12460 participants
Primary outcome timeframe
From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year
Results posted on
2021-10-05
Participant Flow
Participant milestones
| Measure |
M-001
Participants will be vaccinated with 1mg dose of M-001 twice: Once at Day 0, and once at Day 21.
M-001: A recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses.
|
Saline
Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.
Saline: 0.9% sodium chloride (NaCl)
|
|---|---|---|
|
Overall Study
STARTED
|
6230
|
6230
|
|
Overall Study
COMPLETED
|
5827
|
5855
|
|
Overall Study
NOT COMPLETED
|
403
|
375
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pivotal Trial to Assess the Safety and Clinical Efficacy of the M-001 as a Standalone Universal Flu Vaccine
Baseline characteristics by cohort
| Measure |
M-001
n=6229 Participants
Participants will be vaccinated with 1mg dose of M-001 twice: Once at Day 0, and once at Day 21.
M-001: A recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses.
|
Saline
n=6229 Participants
Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.
Saline: 0.9% sodium chloride (NaCl)
|
Total
n=12458 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3082 Participants
n=5 Participants
|
3081 Participants
n=7 Participants
|
6163 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3147 Participants
n=5 Participants
|
3148 Participants
n=7 Participants
|
6295 Participants
n=5 Participants
|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
64.6 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
64.6 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3454 Participants
n=5 Participants
|
3486 Participants
n=7 Participants
|
6940 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2775 Participants
n=5 Participants
|
2743 Participants
n=7 Participants
|
5518 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
6227 Participants
n=5 Participants
|
6228 Participants
n=7 Participants
|
12455 Participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
1751 participants
n=5 Participants
|
1749 participants
n=7 Participants
|
3500 participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
78 participants
n=5 Participants
|
82 participants
n=7 Participants
|
160 participants
n=5 Participants
|
|
Region of Enrollment
Georgia
|
258 participants
n=5 Participants
|
256 participants
n=7 Participants
|
514 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
187 participants
n=5 Participants
|
184 participants
n=7 Participants
|
371 participants
n=5 Participants
|
|
Region of Enrollment
Latvia
|
268 participants
n=5 Participants
|
273 participants
n=7 Participants
|
541 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
2740 participants
n=5 Participants
|
2736 participants
n=7 Participants
|
5476 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
947 participants
n=5 Participants
|
949 participants
n=7 Participants
|
1896 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per yearPopulation: Per protocol population comprises all subjects who received both doses of vaccine or placebo and had at least one contact with study staff after 15 days or more upon second vaccination.
Prevention of influenza disease by comparing the occurrence of either qRT-PCR or culture confirmed influenza in the M-001 experimental group vs. placebo caused by any influenza A or B virus in association with a protocol defined Influenza Like Illness.
Outcome measures
| Measure |
M-001
n=5864 Participants
Participants will be vaccinated with 1mg dose of M-001 twice: Once at Day 0, and once at Day 21.
M-001: A recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses.
|
Saline
n=5905 Participants
Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.
Saline: 0.9% sodium chloride (NaCl)
|
|---|---|---|
|
Number of Participants With qRT-PCR or Culture-confirmed Influenza-like Illness
Both seasons
|
160 Participants
|
138 Participants
|
|
Number of Participants With qRT-PCR or Culture-confirmed Influenza-like Illness
Season 2018/2019
|
74 Participants
|
60 Participants
|
|
Number of Participants With qRT-PCR or Culture-confirmed Influenza-like Illness
Season 2019/2020
|
86 Participants
|
78 Participants
|
PRIMARY outcome
Timeframe: From Day 0 to end of study completion by participant which coincides with end of flu season in the respective year, an average of 4 months per participant per yearPopulation: Safety population comprises all subjects enrolled
Number of participants with one or more Serious Adverse Events, New Onset Chronic illness, and Non-solicited Adverse Events assessed during one flu season per participant
Outcome measures
| Measure |
M-001
n=6230 Participants
Participants will be vaccinated with 1mg dose of M-001 twice: Once at Day 0, and once at Day 21.
M-001: A recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses.
|
Saline
n=6230 Participants
Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.
Saline: 0.9% sodium chloride (NaCl)
|
|---|---|---|
|
Number of Participants With One or More Serious Adverse Events, New Onset Chronic Illness, and Non-solicited Adverse Events
Serious Adverse Events
|
185 participants
|
177 participants
|
|
Number of Participants With One or More Serious Adverse Events, New Onset Chronic Illness, and Non-solicited Adverse Events
New Onset Chronic Illness
|
167 participants
|
166 participants
|
|
Number of Participants With One or More Serious Adverse Events, New Onset Chronic Illness, and Non-solicited Adverse Events
Non-solicited Adverse Events
|
781 participants
|
760 participants
|
SECONDARY outcome
Timeframe: From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per yearPopulation: Per protocol population comprises all subjects who received both doses of vaccine or placebo and had at least one contact with study staff after 15 days or more upon second vaccination.
Occurrence of culture confirmed influenza in the M-001 experimental group vs. placebo caused by any influenza A or B virus in association with a protocol defined Influenza Like Illness.
Outcome measures
| Measure |
M-001
n=5864 Participants
Participants will be vaccinated with 1mg dose of M-001 twice: Once at Day 0, and once at Day 21.
M-001: A recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses.
|
Saline
n=5905 Participants
Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.
Saline: 0.9% sodium chloride (NaCl)
|
|---|---|---|
|
Number of Participants With Culture-confirmed Influenza Incidence
|
111 Participants
|
96 Participants
|
SECONDARY outcome
Timeframe: From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per yearPopulation: Per protocol population comprises all subjects who received both doses of vaccine or placebo and had at least one contact with study staff after 15 days or more upon second vaccination.
Assessed by reduction of severity of either qRT-PCR or culture-confirmed influenza illness by the reduction due to M-001 in the average number of days with respiratory or systemic symptoms during the first laboratory-confirmed influenza illness episode.
Outcome measures
| Measure |
M-001
n=5864 Participants
Participants will be vaccinated with 1mg dose of M-001 twice: Once at Day 0, and once at Day 21.
M-001: A recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses.
|
Saline
n=5905 Participants
Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.
Saline: 0.9% sodium chloride (NaCl)
|
|---|---|---|
|
Number of Participants With Reduction of Severity of qRT-PCR or Culture-confirmed Influenza
< 7 days
|
13 Participants
|
12 Participants
|
|
Number of Participants With Reduction of Severity of qRT-PCR or Culture-confirmed Influenza
>= 7 - 14 days
|
94 Participants
|
71 Participants
|
|
Number of Participants With Reduction of Severity of qRT-PCR or Culture-confirmed Influenza
>=14 - 21 days
|
29 Participants
|
29 Participants
|
|
Number of Participants With Reduction of Severity of qRT-PCR or Culture-confirmed Influenza
>= 21 days
|
24 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per yearPopulation: Per protocol population comprises all subjects who received both doses of vaccine or placebo and had at least one contact with study staff after 15 days or more upon second vaccination.
Assessment of number of participants having ILI symptoms in the experimental or control group
Outcome measures
| Measure |
M-001
n=5864 Participants
Participants will be vaccinated with 1mg dose of M-001 twice: Once at Day 0, and once at Day 21.
M-001: A recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses.
|
Saline
n=5905 Participants
Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.
Saline: 0.9% sodium chloride (NaCl)
|
|---|---|---|
|
Number of Participants With Influenza-like Illness Symptoms
|
1231 Participants
|
1266 Participants
|
Adverse Events
M-001
Serious events: 185 serious events
Other events: 781 other events
Deaths: 26 deaths
Saline
Serious events: 177 serious events
Other events: 760 other events
Deaths: 29 deaths
Serious adverse events
| Measure |
M-001
n=6230 participants at risk
Participants will be vaccinated with 1mg dose of M-001 twice: Once at Day 0, and once at Day 21.
M-001: A recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses.
|
Saline
n=6230 participants at risk
Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.
Saline: 0.9% sodium chloride (NaCl)
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal Cancer
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Cancer
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Nervous system disorders
Cerebral Infarction
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Nervous system disorders
Cerebrospinal Fluid Circulation Disorder
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Nervous system disorders
Ischaemic Stroke
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.08%
5/6230 • Number of events 5 • 4 months
|
|
Nervous system disorders
Syncope
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.05%
3/6230 • Number of events 3 • 4 months
|
|
Nervous system disorders
Cerebrovascular Insufficiency
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Nervous system disorders
Encephalopathy
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.05%
3/6230 • Number of events 3 • 4 months
|
|
Nervous system disorders
Headache
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Nervous system disorders
Lumbar Radiculopathy
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Nervous system disorders
Ulnar Tunnel Syndrome
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.00%
0/6230 • 4 months
|
0.03%
2/6230 • Number of events 2 • 4 months
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Nervous system disorders
Vertebrobasilar Insufficiency
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Psychiatric disorders
Depression
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Psychiatric disorders
Reactive Psychosis
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Renal and urinary disorders
Calculus Urinary
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Renal and urinary disorders
Cystitis Noninfective
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Renal and urinary disorders
Renal Colic
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Reproductive system and breast disorders
Endometrial Hypertrophy
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Reproductive system and breast disorders
Reproductive Tract Disorder
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Reproductive system and breast disorders
Uterine Haemorrhage
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Reproductive system and breast disorders
Postmenopausal Haemorrhage
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.43%
27/6230 • Number of events 29 • 4 months
|
0.45%
28/6230 • Number of events 30 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.16%
10/6230 • Number of events 10 • 4 months
|
0.14%
9/6230 • Number of events 10 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.11%
7/6230 • Number of events 7 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis Chronic
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Respiratory Failure
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Skin and subcutaneous tissue disorders
Diabetic Foot
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Vascular disorders
Hypertension
|
0.06%
4/6230 • Number of events 4 • 4 months
|
0.10%
6/6230 • Number of events 6 • 4 months
|
|
Vascular disorders
Hypertensive Crisis
|
0.06%
4/6230 • Number of events 4 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Vascular disorders
Hypotension
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Vascular disorders
Steal Syndrome
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Vascular disorders
Thrombosis
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Vascular disorders
Bleeding Varicose Vein
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Vascular disorders
Circulatory Collapse
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Vascular disorders
Vascular Occlusion
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Vascular disorders
Venous Thrombosis
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Cardiac disorders
Myocardial Infarction 6 (
|
0.10%
6/6230 • Number of events 6 • 4 months
|
0.10%
6/6230 • Number of events 6 • 4 months
|
|
Cardiac disorders
Cardiac Arrest
|
0.08%
5/6230 • Number of events 5 • 4 months
|
0.03%
2/6230 • Number of events 2 • 4 months
|
|
Cardiac disorders
Cardiac Failure
|
0.08%
5/6230 • Number of events 5 • 4 months
|
0.03%
2/6230 • Number of events 4 • 4 months
|
|
Cardiac disorders
Angina Pectoris
|
0.05%
3/6230 • Number of events 4 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Cardiac disorders
Coronary Artery Disease
|
0.05%
3/6230 • Number of events 3 • 4 months
|
0.05%
3/6230 • Number of events 3 • 4 months
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Cardiac disorders
Angina Unstable
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.06%
4/6230 • Number of events 4 • 4 months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.05%
3/6230 • Number of events 3 • 4 months
|
|
Cardiac disorders
Cardiac Failure Chronic
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.08%
5/6230 • Number of events 5 • 4 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Cardiac disorders
Cardiac Valve Disease
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Cardiac disorders
Cardiovascular Insufficiency
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Cardiac disorders
Atrial Tachycardia
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Cardiac disorders
Cardiovascular Disorder
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/6230 • 4 months
|
0.06%
4/6230 • Number of events 4 • 4 months
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Ear and labyrinth disorders
V
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Endocrine disorders
Thyroiditis Subacute
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Eye disorders
Posterior Capsule Rupture
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Gastrointestinal disorders
Ileus
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Gastrointestinal disorders
Pancreatitis Necrotising
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Gastrointestinal disorders
Gastrointestinal Obstruction
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Gastrointestinal disorders
Retroperitoneal Mass
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
General disorders
Adverse Event
|
0.05%
3/6230 • Number of events 3 • 4 months
|
0.03%
2/6230 • Number of events 2 • 4 months
|
|
General disorders
Death
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.03%
2/6230 • Number of events 2 • 4 months
|
|
General disorders
Sudden Death
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.05%
3/6230 • Number of events 3 • 4 months
|
|
General disorders
Chest Pain
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
General disorders
Facial Pain
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
General disorders
Malaise
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
General disorders
Sudden Cardiac Death
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.05%
3/6230 • Number of events 3 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Hepatobiliary disorders
Bile Duct Obstruction
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Hepatobiliary disorders
Acute Hepatic Failure
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Hepatobiliary disorders
Biliary Dyskinesia
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Hepatobiliary disorders
Cholecystitis Acute 0 0
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Infections and infestations
Pneumonia
|
0.26%
16/6230 • Number of events 16 • 4 months
|
0.21%
13/6230 • Number of events 13 • 4 months
|
|
Infections and infestations
Respiratory Tract Infection
|
0.05%
3/6230 • Number of events 3 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Infections and infestations
Atypical Pneumonia
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Infections and infestations
Pneumonia Bacterial
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Infections and infestations
Sinusitis
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Infections and infestations
Bacterial Infection
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Infections and infestations
Bronchitis
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.06%
4/6230 • Number of events 4 • 4 months
|
|
Infections and infestations
conjunctivitis
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Infections and infestations
Corona Virus Infection
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Infections and infestations
Laryngitis
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Infections and infestations
Parotitis
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Infections and infestations
Pyelonephritis Chronic
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Infections and infestations
Abdominal Abscess
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 2 • 4 months
|
|
Infections and infestations
Anal Abscess
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Infections and infestations
Appendicitis
|
0.00%
0/6230 • 4 months
|
0.03%
2/6230 • Number of events 2 • 4 months
|
|
Infections and infestations
Bacterial Pyelonephritis
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Infections and infestations
Endocarditis
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Infections and infestations
Influenza
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Infections and infestations
Respiratory Tract Infection Bacterial
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/6230 • 4 months
|
0.03%
2/6230 • Number of events 2 • 4 months
|
|
Injury, poisoning and procedural complications
Coronary Artery Restenosis
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Injury, poisoning and procedural complications
Pubis Fracture
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6230 • 4 months
|
0.05%
3/6230 • Number of events 3 • 4 months
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Injury, poisoning and procedural complications
Fractured Coccyx
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.00%
0/6230 • 4 months
|
0.05%
3/6230 • Number of events 3 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia Rheumatica
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Spinal Disorder
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Of Colon
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.05%
3/6230 • Number of events 3 • 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Small Cell Lung Cancer
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid Cancer
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Neoplasm
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Lung Cancer
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue Neoplasm Benign
|
0.02%
1/6230 • Number of events 1 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal Adenoma
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Recurrent
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Stage II
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic Naevus
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial Cancer
|
0.00%
0/6230 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
Other adverse events
| Measure |
M-001
n=6230 participants at risk
Participants will be vaccinated with 1mg dose of M-001 twice: Once at Day 0, and once at Day 21.
M-001: A recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses.
|
Saline
n=6230 participants at risk
Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.
Saline: 0.9% sodium chloride (NaCl)
|
|---|---|---|
|
Cardiac disorders
Cardiac Failure
|
0.10%
6/6230 • Number of events 6 • 4 months
|
0.08%
5/6230 • Number of events 7 • 4 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.10%
6/6230 • Number of events 6 • 4 months
|
0.10%
6/6230 • Number of events 6 • 4 months
|
|
Cardiac disorders
Cardiac Failure Chronic
|
0.06%
4/6230 • Number of events 4 • 4 months
|
0.10%
6/6230 • Number of events 6 • 4 months
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.05%
3/6230 • Number of events 3 • 4 months
|
0.11%
7/6230 • Number of events 7 • 4 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.21%
13/6230 • Number of events 13 • 4 months
|
0.21%
13/6230 • Number of events 13 • 4 months
|
|
Gastrointestinal disorders
Nausea
|
0.13%
8/6230 • Number of events 9 • 4 months
|
0.11%
7/6230 • Number of events 7 • 4 months
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.11%
7/6230 • Number of events 8 • 4 months
|
0.14%
9/6230 • Number of events 10 • 4 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.08%
5/6230 • Number of events 5 • 4 months
|
0.16%
10/6230 • Number of events 10 • 4 months
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.03%
2/6230 • Number of events 2 • 4 months
|
0.10%
6/6230 • Number of events 6 • 4 months
|
|
General disorders
Malaise
|
0.61%
38/6230 • Number of events 40 • 4 months
|
0.53%
33/6230 • Number of events 37 • 4 months
|
|
General disorders
Pyrexia
|
0.53%
33/6230 • Number of events 35 • 4 months
|
0.30%
19/6230 • Number of events 20 • 4 months
|
|
General disorders
Chills
|
0.42%
26/6230 • Number of events 28 • 4 months
|
0.32%
20/6230 • Number of events 24 • 4 months
|
|
General disorders
Injection Site Pain
|
0.34%
21/6230 • Number of events 22 • 4 months
|
0.05%
3/6230 • Number of events 3 • 4 months
|
|
General disorders
Fatigue
|
0.27%
17/6230 • Number of events 18 • 4 months
|
0.24%
15/6230 • Number of events 16 • 4 months
|
|
General disorders
Injection Site Bruising
|
0.24%
15/6230 • Number of events 15 • 4 months
|
0.21%
13/6230 • Number of events 13 • 4 months
|
|
General disorders
Injection Site Erythema
|
0.13%
8/6230 • Number of events 8 • 4 months
|
0.03%
2/6230 • Number of events 2 • 4 months
|
|
General disorders
Asthenia
|
0.11%
7/6230 • Number of events 7 • 4 months
|
0.14%
9/6230 • Number of events 9 • 4 months
|
|
Infections and infestations
Nasopharyngitis
|
0.40%
25/6230 • Number of events 25 • 4 months
|
0.37%
23/6230 • Number of events 24 • 4 months
|
|
Infections and infestations
Pneumonia
|
0.30%
19/6230 • Number of events 19 • 4 months
|
0.26%
16/6230 • Number of events 16 • 4 months
|
|
Infections and infestations
Rhinitis
|
0.26%
16/6230 • Number of events 16 • 4 months
|
0.22%
14/6230 • Number of events 14 • 4 months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.26%
16/6230 • Number of events 16 • 4 months
|
0.29%
18/6230 • Number of events 18 • 4 months
|
|
Infections and infestations
Bronchitis
|
0.21%
13/6230 • Number of events 13 • 4 months
|
0.26%
16/6230 • Number of events 16 • 4 months
|
|
Infections and infestations
Respiratory Tract Infection
|
0.21%
13/6230 • Number of events 13 • 4 months
|
0.13%
8/6230 • Number of events 9 • 4 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.19%
12/6230 • Number of events 12 • 4 months
|
0.10%
6/6230 • Number of events 6 • 4 months
|
|
Infections and infestations
Viral Infection
|
0.14%
9/6230 • Number of events 10 • 4 months
|
0.11%
7/6230 • Number of events 7 • 4 months
|
|
Infections and infestations
Herpes Zoster
|
0.11%
7/6230 • Number of events 7 • 4 months
|
0.02%
1/6230 • Number of events 1 • 4 months
|
|
Infections and infestations
Conjunctivitis
|
0.10%
6/6230 • Number of events 6 • 4 months
|
0.06%
4/6230 • Number of events 4 • 4 months
|
|
Investigations
Blood Pressure Decreased
|
0.19%
12/6230 • Number of events 14 • 4 months
|
0.10%
6/6230 • Number of events 6 • 4 months
|
|
Investigations
Blood Pressure Increased
|
0.10%
6/6230 • Number of events 6 • 4 months
|
0.18%
11/6230 • Number of events 12 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
77/6230 • Number of events 84 • 4 months
|
0.87%
54/6230 • Number of events 60 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.45%
28/6230 • Number of events 30 • 4 months
|
0.42%
26/6230 • Number of events 28 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.13%
8/6230 • Number of events 8 • 4 months
|
0.18%
11/6230 • Number of events 11 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.11%
7/6230 • Number of events 7 • 4 months
|
0.10%
6/6230 • Number of events 6 • 4 months
|
|
Nervous system disorders
Headache
|
1.7%
106/6230 • Number of events 113 • 4 months
|
1.4%
90/6230 • Number of events 99 • 4 months
|
|
Nervous system disorders
Dizziness
|
0.26%
16/6230 • Number of events 17 • 4 months
|
0.30%
19/6230 • Number of events 21 • 4 months
|
|
Psychiatric disorders
Irritability
|
0.24%
15/6230 • Number of events 15 • 4 months
|
0.27%
17/6230 • Number of events 18 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.91%
57/6230 • Number of events 60 • 4 months
|
0.96%
60/6230 • Number of events 65 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.67%
42/6230 • Number of events 50 • 4 months
|
0.88%
55/6230 • Number of events 57 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.64%
40/6230 • Number of events 43 • 4 months
|
0.66%
41/6230 • Number of events 43 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.53%
33/6230 • Number of events 35 • 4 months
|
0.63%
39/6230 • Number of events 42 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.39%
24/6230 • Number of events 25 • 4 months
|
0.32%
20/6230 • Number of events 20 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.32%
20/6230 • Number of events 21 • 4 months
|
0.18%
11/6230 • Number of events 11 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.30%
19/6230 • Number of events 19 • 4 months
|
0.21%
13/6230 • Number of events 14 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.11%
7/6230 • Number of events 7 • 4 months
|
0.00%
0/6230 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.10%
6/6230 • Number of events 6 • 4 months
|
0.08%
5/6230 • Number of events 5 • 4 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.42%
26/6230 • Number of events 28 • 4 months
|
0.37%
23/6230 • Number of events 26 • 4 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.34%
21/6230 • Number of events 21 • 4 months
|
0.27%
17/6230 • Number of events 17 • 4 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.11%
7/6230 • Number of events 7 • 4 months
|
0.03%
2/6230 • Number of events 2 • 4 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.11%
7/6230 • Number of events 7 • 4 months
|
0.24%
15/6230 • Number of events 15 • 4 months
|
|
Vascular disorders
Hypertension
|
0.42%
26/6230 • Number of events 26 • 4 months
|
0.47%
29/6230 • Number of events 30 • 4 months
|
|
Vascular disorders
Hypertensive Crises
|
0.13%
8/6230 • Number of events 8 • 4 months
|
0.03%
2/6230 • Number of events 2 • 4 months
|
Additional Information
Chief Scientific Officer & Clinical Management
BiondVax Pharmaceuticals ltd.
Phone: +97289302529
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place