Clinical Trial Search

Primary: Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28). — 71.2; 68.5; 73.9; 76.7…

Primary: Number of Participants With Serious Adverse Events (SAEs). — 0; 0 Participants

Primary: Local AEs — 500; 344; 186; 189 injections

Primary: Number of Participants Who Developed a Positive Anti-raxibacumab Antibody Response — 0 Participants

Primary: Number of Participants Reporting Adverse Events (AEs) — 28; 5; 29; 11 Participants

Primary: ELISA Seropositivity Rate — 40.9; 100.0 percentage of subjects

Primary: Solicited Local Reactogenicity Symptoms — 46; 43; 40; 45 Participants

Primary: Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) — 11; 17; 13…

Primary: Ratios of Ciprofloxacin Area Under the Curve and Cmax (Day 5/Day 44) — 0.944; 0.887 ratio

Primary: Count of White Blood Cells (WBC) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With…

Primary: All Cause Mortality — 0; 1 participants

Primary: Number of Participants Surviving Through LFU Visit — 191; 196; 64; 57 Participants — p=0.4263

Primary: Ratio of Geometric Mean Concentrations (GMC) of Anti-protective Antigen (PA) Antibody (Ab) at 4 Weeks (Day 29) After the First AVA Dose (Prior to the Third AVA Dose)…

Primary: Number of Participants With a Four-fold or Greater Increase From Baseline in Toxin Neutralization Antibody Assay (TNA) 50 Percent Neutralization Factor ( NF50 ) Antibody…

Primary: Geometric Mean Titer (GMT) Based on Vaccinia-specific Individual Peak Plaque Reduction Neutralization Titers (PRNT) Following 2 Doses of IMVAMUNE® Lyophilized Versus…

Primary: Change in Semi-Quantitative Mycobacterial Culture Results From Baseline to Day 84. — 5; 5; 1; 1 Participants — p=0.072

Primary: Geometric Mean Titer (GMT) of Toxin Neutralizing Antibody (TNA) 50% Neutralization Factor (NF50) at Day 64 — 0.765; 0.741; 0.716; 0.330 Titer (TNA NF50)

Primary: Median Difference in CD4 Cell Response to Intrabronchial Instillation of Tuberculin Purified Protein Derivative (PPD) — 5.26; 0.725; 29.9; 2.92 % Antigen Specific T…

Primary: Toxin Neutralizing Antibody (TNA) Level at Day 63 — 56.8; 100; 100; 90.2 percentage of participants

Primary: Change From Baseline to 4 Hours in Sputum Percent Neutrophils — -0.04; -0.5 percent neutrophils — p=> 0.99

Primary: Change in QOL-B Respiratory Symptoms Score at Day 28 — 7.4; 5.7 units on a scale — p=0.68

Primary: Number of Participants With Sputum Culture Conversion to Negative — 2; 3 Participants

Primary: Change in QOL-B Respiratory Symptoms Score at Day 28 — 8.2; 3.2 units on a scale — p=0.011

Primary: Elevated Serum Tobramycin Trough or Creatinine or Severe Adverse Event — 0; 0; 0; 1 Participants

Primary: Severity of COVID-19: Evaluation of the Severity of COVID-19 as Measured by the Maximum Difference From the Baseline Value in the OSCI Within 28 Days From the Start of…

Primary: Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29). — -2.94; -0.32 log10 of CFU per gram sputum — p=< 0.001

Primary: Change From Baseline to 4 Hours in Sputum Percent Neutrophils — -2.62; 5.45 percent neutrophils — p=0.24

Primary: Number of Patients MRSA Free by Induced Sputum Respiratory Tract Culture — 2; 3 Participants

Primary: Ratio of Ciprofloxacin Area Under the Curve From 0 to 12 Hours (AUC0-12h) and Maximum Concentration (Cmax) on Days 8 and 35 — 0.9764; 0.9706 Ratio

Primary: Time to First Exacerbation Event Within 48 Weeks — 336; NA; 186 Days — p=0.0650