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A Pivotal Trial to Assess the Safety and Clinical Efficacy of the M-001 as a Standalone Universal Flu Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03450915
Recruitment Status : Completed
First Posted : March 1, 2018
Results First Posted : September 13, 2021
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
BiondVax Pharmaceuticals ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Influenza
Interventions Biological: M-001
Biological: Saline
Enrollment 12460
Recruitment Details  
Pre-assignment Details  
Arm/Group Title M-001 Saline
Hide Arm/Group Description

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.

Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.

Saline: 0.9% sodium chloride (NaCl)

Period Title: Overall Study
Started 6230 6230
Completed 5827 5855
Not Completed 403 375
Arm/Group Title M-001 Saline Total
Hide Arm/Group Description

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.

Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.

Saline: 0.9% sodium chloride (NaCl)

Total of all reporting groups
Overall Number of Baseline Participants 6229 6229 12458
Hide Baseline Analysis Population Description
Baseline analysis population is the Intention-to-treat population, i.e. subjects who received at least one vaccination
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6229 participants 6229 participants 12458 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3082
  49.5%
3081
  49.5%
6163
  49.5%
>=65 years
3147
  50.5%
3148
  50.5%
6295
  50.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6229 participants 6229 participants 12458 participants
64.6  (8.7) 64.6  (8.7) 64.6  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6229 participants 6229 participants 12458 participants
Female
3454
  55.5%
3486
  56.0%
6940
  55.7%
Male
2775
  44.5%
2743
  44.0%
5518
  44.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6229 participants 6229 participants 12458 participants
Asian
2
   0.0%
1
   0.0%
3
   0.0%
White
6227
 100.0%
6228
 100.0%
12455
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6229 participants 6229 participants 12458 participants
Bulgaria 1751 1749 3500
Croatia 78 82 160
Georgia 258 256 514
Hungary 187 184 371
Latvia 268 273 541
Poland 2740 2736 5476
Ukraine 947 949 1896
1.Primary Outcome
Title Number of Participants With qRT-PCR or Culture-confirmed Influenza-like Illness
Hide Description 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.
Time Frame From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title M-001 Saline
Hide Arm/Group Description:

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.

Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.

Saline: 0.9% sodium chloride (NaCl)

Overall Number of Participants Analyzed 5864 5905
Measure Type: Count of Participants
Unit of Measure: Participants
Both seasons Number Analyzed 5864 participants 5905 participants
160
   2.7%
138
   2.3%
Season 2018/2019 Number Analyzed 1906 participants 1917 participants
74
   3.9%
60
   3.1%
Season 2019/2020 Number Analyzed 3958 participants 3988 participants
86
   2.2%
78
   2.0%
2.Primary Outcome
Title Number of Participants With One or More Serious Adverse Events, New Onset Chronic Illness, and Non-solicited Adverse Events
Hide Description 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
Time Frame 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 year
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population comprises all subjects enrolled
Arm/Group Title M-001 Saline
Hide Arm/Group Description:

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.

Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.

Saline: 0.9% sodium chloride (NaCl)

Overall Number of Participants Analyzed 6230 6230
Measure Type: Number
Unit of Measure: participants
Serious Adverse Events 185 177
New Onset Chronic Illness 167 166
Non-solicited Adverse Events 781 760
3.Secondary Outcome
Title Number of Participants With Culture-confirmed Influenza Incidence
Hide Description 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.
Time Frame From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title M-001 Saline
Hide Arm/Group Description:

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.

Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.

Saline: 0.9% sodium chloride (NaCl)

Overall Number of Participants Analyzed 5864 5905
Measure Type: Count of Participants
Unit of Measure: Participants
111
   1.9%
96
   1.6%
4.Secondary Outcome
Title Number of Participants With Reduction of Severity of qRT-PCR or Culture-confirmed Influenza
Hide Description 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.
Time Frame From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title M-001 Saline
Hide Arm/Group Description:

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.

Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.

Saline: 0.9% sodium chloride (NaCl)

Overall Number of Participants Analyzed 5864 5905
Measure Type: Count of Participants
Unit of Measure: Participants
< 7 days
13
   0.2%
12
   0.2%
>= 7 - 14 days
94
   1.6%
71
   1.2%
>=14 - 21 days
29
   0.5%
29
   0.5%
>= 21 days
24
   0.4%
26
   0.4%
5.Secondary Outcome
Title Number of Participants With Influenza-like Illness Symptoms
Hide Description Assessment of number of participants having ILI symptoms in the experimental or control group
Time Frame From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title M-001 Saline
Hide Arm/Group Description:

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.

Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.

Saline: 0.9% sodium chloride (NaCl)

Overall Number of Participants Analyzed 5864 5905
Measure Type: Count of Participants
Unit of Measure: Participants
1231
  21.0%
1266
  21.4%
Time Frame 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title M-001 Saline
Hide Arm/Group Description

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.

Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.

Saline: 0.9% sodium chloride (NaCl)

All-Cause Mortality
M-001 Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   26/6230 (0.42%)      29/6230 (0.47%)    
Hide Serious Adverse Events
M-001 Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   185/6230 (2.97%)      177/6230 (2.84%)    
Blood and lymphatic system disorders     
Iron Deficiency Anaemia  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Neutropenia  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Cardiac disorders     
Myocardial Infarction 6 (  1  6/6230 (0.10%)  6 6/6230 (0.10%)  6
Cardiac Arrest  1  5/6230 (0.08%)  5 2/6230 (0.03%)  2
Cardiac Failure  1  5/6230 (0.08%)  5 2/6230 (0.03%)  4
Angina Pectoris  1  3/6230 (0.05%)  4 0/6230 (0.00%)  0
Coronary Artery Disease  1  3/6230 (0.05%)  3 3/6230 (0.05%)  3
Acute Coronary Syndrome  1  2/6230 (0.03%)  2 0/6230 (0.00%)  0
Angina Unstable  1  2/6230 (0.03%)  2 4/6230 (0.06%)  4
Atrial Fibrillation  1  2/6230 (0.03%)  2 3/6230 (0.05%)  3
Cardiac Failure Chronic  1  2/6230 (0.03%)  2 5/6230 (0.08%)  5
Cardiac Failure Congestive  1  2/6230 (0.03%)  2 1/6230 (0.02%)  1
Acute Myocardial Infarction  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Cardiac Valve Disease  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Cardiovascular Insufficiency  1  1/6230 (0.02%)  1 1/6230 (0.02%)  1
Mitral Valve Incompetence  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Arrhythmia  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Atrial Tachycardia  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Cardiovascular Disorder  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Myocardial Ischaemia  1  0/6230 (0.00%)  0 4/6230 (0.06%)  4
Ventricular Tachycardia  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Ear and labyrinth disorders     
 1  2/6230 (0.03%)  2 0/6230 (0.00%)  0
Hypoacusis  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Endocrine disorders     
Thyroiditis Subacute  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Eye disorders     
Posterior Capsule Rupture  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Gastrointestinal disorders     
Haemorrhoidal Haemorrhage  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Ileus  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Pancreatitis Necrotising  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Umbilical Hernia  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Gastritis  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Gastrointestinal Obstruction  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Intestinal Perforation  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Irritable Bowel Syndrome  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Retroperitoneal Mass  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
General disorders     
Adverse Event  1  3/6230 (0.05%)  3 2/6230 (0.03%)  2
Death  1  2/6230 (0.03%)  2 2/6230 (0.03%)  2
Sudden Death  1  1/6230 (0.02%)  1 3/6230 (0.05%)  3
Chest Pain  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Facial Pain  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
General Physical Health Deterioration  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Malaise  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Sudden Cardiac Death  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Hepatobiliary disorders     
Cholelithiasis  1  3/6230 (0.05%)  3 1/6230 (0.02%)  1
Bile Duct Obstruction  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Cholecystitis  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Cholecystitis Chronic  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Acute Hepatic Failure  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Biliary Dyskinesia  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Cholecystitis Acute 0 0  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Infections and infestations     
Pneumonia  1  16/6230 (0.26%)  16 13/6230 (0.21%)  13
Respiratory Tract Infection  1  3/6230 (0.05%)  3 0/6230 (0.00%)  0
Atypical Pneumonia  1  2/6230 (0.03%)  2 0/6230 (0.00%)  0
Pneumonia Bacterial  1  2/6230 (0.03%)  2 0/6230 (0.00%)  0
Sinusitis  1  2/6230 (0.03%)  2 0/6230 (0.00%)  0
Urinary Tract Infection  1  2/6230 (0.03%)  2 0/6230 (0.00%)  0
Bacterial Infection  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Bronchitis  1  1/6230 (0.02%)  1 4/6230 (0.06%)  4
conjunctivitis  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Corona Virus Infection  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Laryngitis  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Parotitis  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Pulmonary Tuberculosis  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Pyelonephritis Chronic  1  1/6230 (0.02%)  1 1/6230 (0.02%)  1
Abdominal Abscess  1  0/6230 (0.00%)  0 1/6230 (0.02%)  2
Anal Abscess  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Appendicitis  1  0/6230 (0.00%)  0 2/6230 (0.03%)  2
Bacterial Pyelonephritis  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Bronchiolitis  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Endocarditis  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Influenza  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Pharyngitis  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Respiratory Tract Infection Bacterial  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Upper Respiratory Tract Infection  1  0/6230 (0.00%)  0 2/6230 (0.03%)  2
Injury, poisoning and procedural complications     
Coronary Artery Restenosis  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Foot Fracture  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Pubis Fracture  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Radius Fracture  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Wrist Fracture  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Concussion  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Fall  1  0/6230 (0.00%)  0 3/6230 (0.05%)  3
Femur Fracture  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Fractured Coccyx  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Head Injury  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Meniscus Injury  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Road Traffic Accident  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Wound  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Metabolism and nutrition disorders     
Diabetes Mellitus  1  2/6230 (0.03%)  2 1/6230 (0.02%)  1
Hyperglycaemia  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Hypoglycaemia  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Type 2 Diabetes Mellitus  1  0/6230 (0.00%)  0 3/6230 (0.05%)  3
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Osteochondrosis  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Periarthritis  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Polymyalgia Rheumatica  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Arthralgia  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Scleroderma  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Spinal Disorder  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastric Cancer  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Laryngeal Cancer  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Myelofibrosis  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Ovarian Cancer  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Prostate Cancer  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Uterine Cancer  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Pancreatic Carcinoma  1  2/6230 (0.03%)  2 0/6230 (0.00%)  0
Adenocarcinoma Of Colon  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Brain Neoplasm  1  1/6230 (0.02%)  1 1/6230 (0.02%)  1
Breast Cancer  1  1/6230 (0.02%)  1 3/6230 (0.05%)  3
Colon Cancer  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Lung Neoplasm Malignant  1  1/6230 (0.02%)  1 1/6230 (0.02%)  1
Non-Small Cell Lung Cancer  1  1/6230 (0.02%)  1 1/6230 (0.02%)  1
Rectosigmoid Cancer  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Renal Neoplasm  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Small Cell Lung Cancer  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Tongue Neoplasm Benign  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Adrenal Adenoma  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Bladder Cancer  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Breast Cancer Recurrent  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Breast Cancer Stage II  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Dysplastic Naevus  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Endometrial Cancer  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Nervous system disorders     
Cerebral Haemorrhage  1  2/6230 (0.03%)  2 0/6230 (0.00%)  0
Cerebral Infarction  1  2/6230 (0.03%)  2 0/6230 (0.00%)  0
Cerebrospinal Fluid Circulation Disorder  1  2/6230 (0.03%)  2 0/6230 (0.00%)  0
Ischaemic Stroke  1  2/6230 (0.03%)  2 5/6230 (0.08%)  5
Syncope  1  2/6230 (0.03%)  2 1/6230 (0.02%)  1
Transient Ischaemic Attack  1  2/6230 (0.03%)  2 1/6230 (0.02%)  1
Carpal Tunnel Syndrome  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Cerebrovascular Accident  1  1/6230 (0.02%)  1 3/6230 (0.05%)  3
Cerebrovascular Insufficiency  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Encephalopathy  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Haemorrhagic Stroke  1  1/6230 (0.02%)  1 3/6230 (0.05%)  3
Headache  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Lumbar Radiculopathy  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Ulnar Tunnel Syndrome  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Carotid Artery Stenosis  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Cerebral Ischaemia  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Dizziness  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Haemorrhage Intracranial  1  0/6230 (0.00%)  0 2/6230 (0.03%)  2
Radiculopathy  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Vertebrobasilar Insufficiency  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Psychiatric disorders     
Depression  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Reactive Psychosis  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Renal and urinary disorders     
Acute Kidney Injury  1  2/6230 (0.03%)  2 1/6230 (0.02%)  1
Calculus Urinary  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Cystitis Noninfective  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Renal Colic  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Ureterolithiasis  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Chronic Kidney Disease  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Reproductive system and breast disorders     
Benign Prostatic Hyperplasia  1  1/6230 (0.02%)  1 1/6230 (0.02%)  1
Endometrial Hypertrophy  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Reproductive Tract Disorder  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Uterine Haemorrhage  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Postmenopausal Haemorrhage  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic Obstructive Pulmonary Disease  1  27/6230 (0.43%)  29 28/6230 (0.45%)  30
Asthma  1  10/6230 (0.16%)  10 9/6230 (0.14%)  10
Pulmonary Embolism  1  7/6230 (0.11%)  7 0/6230 (0.00%)  0
Bronchiectasis  1  2/6230 (0.03%)  2 1/6230 (0.02%)  1
Interstitial Lung Disease  1  2/6230 (0.03%)  2 0/6230 (0.00%)  0
Respiratory Failure  1  2/6230 (0.03%)  2 0/6230 (0.00%)  0
Sleep Apnoea Syndrome  1  2/6230 (0.03%)  2 0/6230 (0.00%)  0
Bronchitis Chronic  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Chronic Respiratory Failure  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Pulmonary Fibrosis  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Acute Respiratory Distress Syndrome  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Choking  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Epistaxis  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Lung Disorder  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Lung Infiltration  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Skin and subcutaneous tissue disorders     
Diabetic Foot  1  1/6230 (0.02%)  1 1/6230 (0.02%)  1
Vascular disorders     
Hypertension  1  4/6230 (0.06%)  4 6/6230 (0.10%)  6
Hypertensive Crisis  1  4/6230 (0.06%)  4 1/6230 (0.02%)  1
Hypotension  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Steal Syndrome  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Thrombosis  1  1/6230 (0.02%)  1 0/6230 (0.00%)  0
Bleeding Varicose Vein  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Circulatory Collapse  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Deep Vein Thrombosis  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Phlebitis  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Vascular Occlusion  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
Venous Thrombosis  1  0/6230 (0.00%)  0 1/6230 (0.02%)  1
1
Term from vocabulary, MedDRA (21.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.1%
M-001 Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   781/6230 (12.54%)      760/6230 (12.20%)    
Cardiac disorders     
Cardiac Failure  1  6/6230 (0.10%)  6 5/6230 (0.08%)  7
Myocardial Infarction  1  6/6230 (0.10%)  6 6/6230 (0.10%)  6
Cardiac Failure Chronic  1  4/6230 (0.06%)  4 6/6230 (0.10%)  6
Myocardial Ischaemia  1  3/6230 (0.05%)  3 7/6230 (0.11%)  7
Gastrointestinal disorders     
Diarrhoea  1  13/6230 (0.21%)  13 13/6230 (0.21%)  13
Nausea  1  8/6230 (0.13%)  9 7/6230 (0.11%)  7
Abdominal Pain Upper  1  7/6230 (0.11%)  8 9/6230 (0.14%)  10
Abdominal Pain  1  5/6230 (0.08%)  5 10/6230 (0.16%)  10
Abdominal Discomfort  1  2/6230 (0.03%)  2 6/6230 (0.10%)  6
General disorders     
Malaise  1  38/6230 (0.61%)  40 33/6230 (0.53%)  37
Pyrexia  1  33/6230 (0.53%)  35 19/6230 (0.30%)  20
Chills  1  26/6230 (0.42%)  28 20/6230 (0.32%)  24
Injection Site Pain  1  21/6230 (0.34%)  22 3/6230 (0.05%)  3
Fatigue  1  17/6230 (0.27%)  18 15/6230 (0.24%)  16
Injection Site Bruising  1  15/6230 (0.24%)  15 13/6230 (0.21%)  13
Injection Site Erythema  1  8/6230 (0.13%)  8 2/6230 (0.03%)  2
Asthenia  1  7/6230 (0.11%)  7 9/6230 (0.14%)  9
Infections and infestations     
Nasopharyngitis  1  25/6230 (0.40%)  25 23/6230 (0.37%)  24
Pneumonia  1  19/6230 (0.30%)  19 16/6230 (0.26%)  16
Rhinitis  1  16/6230 (0.26%)  16 14/6230 (0.22%)  14
Upper Respiratory Tract Infection  1  16/6230 (0.26%)  16 18/6230 (0.29%)  18
Bronchitis  1  13/6230 (0.21%)  13 16/6230 (0.26%)  16
Respiratory Tract Infection  1  13/6230 (0.21%)  13 8/6230 (0.13%)  9
Urinary Tract Infection  1  12/6230 (0.19%)  12 6/6230 (0.10%)  6
Viral Infection  1  9/6230 (0.14%)  10 7/6230 (0.11%)  7
Herpes Zoster  1  7/6230 (0.11%)  7 1/6230 (0.02%)  1
Conjunctivitis  1  6/6230 (0.10%)  6 4/6230 (0.06%)  4
Investigations     
Blood Pressure Decreased  1  12/6230 (0.19%)  14 6/6230 (0.10%)  6
Blood Pressure Increased  1  6/6230 (0.10%)  6 11/6230 (0.18%)  12
Musculoskeletal and connective tissue disorders     
Arthralgia  1  77/6230 (1.24%)  84 54/6230 (0.87%)  60
Myalgia  1  28/6230 (0.45%)  30 26/6230 (0.42%)  28
Back Pain  1  8/6230 (0.13%)  8 11/6230 (0.18%)  11
Musculoskeletal Pain  1  7/6230 (0.11%)  7 6/6230 (0.10%)  6
Nervous system disorders     
Headache  1  106/6230 (1.70%)  113 90/6230 (1.44%)  99
Dizziness  1  16/6230 (0.26%)  17 19/6230 (0.30%)  21
Psychiatric disorders     
Irritability  1  15/6230 (0.24%)  15 17/6230 (0.27%)  18
Respiratory, thoracic and mediastinal disorders     
Cough  1  57/6230 (0.91%)  60 60/6230 (0.96%)  65
Rhinorrhoea  1  42/6230 (0.67%)  50 55/6230 (0.88%)  57
Oropharyngeal Pain  1  40/6230 (0.64%)  43 41/6230 (0.66%)  43
Chronic Obstructive Pulmonary Disease  1  33/6230 (0.53%)  35 39/6230 (0.63%)  42
Nasal Congestion  1  24/6230 (0.39%)  25 20/6230 (0.32%)  20
Dyspnoea  1  20/6230 (0.32%)  21 11/6230 (0.18%)  11
Asthma  1  19/6230 (0.30%)  19 13/6230 (0.21%)  14
Pulmonary Embolism  1  7/6230 (0.11%)  7 0/6230 (0.00%)  0
Dysphonia  1  6/6230 (0.10%)  6 5/6230 (0.08%)  5
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  26/6230 (0.42%)  28 23/6230 (0.37%)  26
Pruritus  1  21/6230 (0.34%)  21 17/6230 (0.27%)  17
Erythema  1  7/6230 (0.11%)  7 2/6230 (0.03%)  2
Rash  1  7/6230 (0.11%)  7 15/6230 (0.24%)  15
Vascular disorders     
Hypertension  1  26/6230 (0.42%)  26 29/6230 (0.47%)  30
Hypertensive Crises  1  8/6230 (0.13%)  8 2/6230 (0.03%)  2
1
Term from vocabulary, MedDRA (21.0)
Indicates events were collected by systematic assessment
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: Chief Scientific Officer & Clinical Management
Organization: BiondVax Pharmaceuticals ltd.
Phone: +97289302529 ext 5103
EMail: benyedidia@BiondVax.com
Layout table for additonal information
Responsible Party: BiondVax Pharmaceuticals ltd.
ClinicalTrials.gov Identifier: NCT03450915    
Other Study ID Numbers: BVX-010
First Submitted: February 8, 2018
First Posted: March 1, 2018
Results First Submitted: June 16, 2021
Results First Posted: September 13, 2021
Last Update Posted: October 5, 2021