Clinical Trial Search

Primary: Number of Participants Reporting Solicited Injection Site Erythema and Tenderness Post-vaccination With Either One of Three Formulations of Clostridium Difficile…

Primary: Number of First Primary Episodes of Clostridium Difficile Infection (CDI) (Definition 1) Follow-up After Dose 3 — 17; 25 Episodes

Primary: Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) — 16.7; 16.7; 50.0; 16.7 Percentage of…

Primary: Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a…

Primary: Adjusted Geometric Mean Concentration (GMC) of Clostridium Difficile Toxin A and Toxin B Specific Neutralizing Antibodies at Month 7 for Evaluable Immunogenicity…

Primary: Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose — 0; 0; 0; 8 Participants

Primary: Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 37 — 12.5; 68.4; 85.5 percentage of participants

Primary: Geometric Mean Concentrations (GMCs) of Clostridium Difficile Toxin A and Toxin B Specific Neutralizing Antibodies at Month 7 — 878.8; 873.0; 872.9; 5823.9…

Primary: Seroconversion Rate (SCR) on Day 56 — 71.5; 83.0; 59.6; 0.0 percentage of study participants — p=<0.0001

Primary: Serum Anti-toxin A and Anti-toxin B Antibody Concentrations at Day 14 — 2083.3; 3189.4; 32096.4 EU/mL — p=0.5746

Primary: Number of Participants With Recurrence of Clostridium Difficile Associated Disease (CDAD) — 7; 25 Participants

Primary: The Incidence of CDI in Inpatients Receiving Vancomycin Prophylaxis vs. Placebo Who Are on High-risk Antibiotics and Are Colonized With Toxigenic C. Difficile. — 0; 0…

Primary: Number of Participants With Clostridium Difficile Infection Recurrence. — 34; 21 Participants — p=0.56

Primary: Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT) — 25; 19; 20; 25 Participants

Primary: The Number of Cases of CDI — 103; 0 Participants

Primary: Global Absence of Diarrhea Due to Clostridiodes Difficile 8 Weeks After the Start of the Treatment — 4; 9 Participants — p=0.228

Primary: Change in Total Median Total Colony Forming Units (CFU) of C. Difficile Identified in the Hospital Room Environment for Each Antibiotic Treatment Group. — 56; 33; 149; 7…

Primary: Clostridium Difficile Infection Occurrence — 2; 0 Participants

Primary: Number of Participants With Detectable C. Difficile — 5; 4 Participants

Primary: Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine — 160; 160; 160; 160 Antibody Titer

Primary: Patient Demographics — 54; 46; 63; 29 participants

Primary: Number of Participants With a Clinical Response Outcome of Clostridium Difficile Infection Cure at the End of Study Treatment — 61; 58; 59 participants

Primary: Changes in Clostridium Difficile Bacterial Loads in the Stool — 62102500.00; 40000000.00; 7752750.00; 185000.00 CFUs

Primary: Incidence of Serious Adverse Events Through 56 Days After the Last Treatment With RBX2660 — 10 number of reported SAEs through 56 days

Primary: Safety as Assessed by Number of Participants With Any Adverse Events (AE)s — 4; 4 Participants — p=0.8958

Primary: Percentage of Patients With Clostridium Difficile Infection at 4- Weeks of Follow-up. — 2; 7 Participants — p=0.045

Primary: Nitazoxanide — 27 participants

Primary: Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication — 76; 59 Participants — p=0.0488

Primary: Clinical Remission Rates — 3; 2 Participants

Primary: Number of Participants Who Were CDI-diarrhea Free Through 8 Weeks — 112; 23; 30; 52 Participants