Clinical Trial Search

Primary: The Proportion of Participants With Shigellosis Following Challenge With Shigella Sonnei 53G Through Day 63 in the Pooled Group of Participants Receiving Two Doses of…

Primary: Percentage of Subjects With at Least One Episode of Shigellosis According to the Protocol Primary Case Definition — 46.9; 42.9 Percentage of subjects — p=0.4266

Primary: Maximum Severity of Reactogenicity by Vaccination — 1; 0; 0; 0 Participants

Primary: Number of Participants With Shigellosis — 0; 2; 1; 4 Participants

Primary: Number of Subjects With Solicited Local Reaction After Any Vaccination — 8; 9; 8; 8 Participants

Primary: Number of Participants With Adverse Events — 82; 61; 79; 64 participants

Primary: Number and Percentage of Participants With Serious Adverse Events (SAEs) — 0; 0; 1; 0 Participants

Primary: Number of Participants With Adverse Events — 9; 5; 8; 10 Participants

Primary: Maximum Reactogenicity Per Subject and Treatment Group — 5; 12; 9; 11 Participants

Primary: Number of Participants With Moderate-Severe Shigellosis Illness, With Challenge — 14; 17 Participants

Primary: Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination — 21; 25; 21; 21 Participants

Primary: Post-challenge Diarrhea, Fever, and Blood in Stool Adverse Events by Study Group — 1; 0; 4; 4 participants

Primary: Percentage of Participants With Shigellosis Following Shigella Challenge — 59.1; 80.0; 15.8; 58.3 percentage of participants

Primary: Number of Participants With Post Infectious Irritable Bowel Syndrome — 23; 114 participants

Primary: Participants Experiencing Fever, Diarrhea, or Dysentery; Solicited Local Adverse Events; Solicited Systemic Adverse Events; and Clinical Safety Laboratory Adverse Events…

Primary: Blood Test Performance — 18; 17 Participants

Primary: Safety of Serum Derived Bovine Immunoglobulins (BSIgG) — 1; 2; 0; 2 Participants

Primary: Incidence of Adverse Events — 1; 1; 0; 1 events

Primary: Number of Participants With Solicited or Unsolicited Adverse Events — 15; 16; 17; 16 Participants

Primary: Number of Treatment Related Adverse Events — 27; 37; 41; 46 Adverse Events

Primary: Concentrations of Immunoglobulin (IgG) Against Lipopolysaccharide (LPS) S. Sonnei O-antigen — 168; 5.17; 38 EU/mL

Primary: Number of Participants With Moderate and Severe Diarrhea — 17 participants moderate or severe diarrea

Primary: Treatment Failure — 23; 101 Treatment success

Primary: Attack Rate of Shigellosis in Vaccinated Subjects. — 13; 18 Participants

Primary: Number of Participants With Modified Vesikari Scale Score >=9 — 55; 60 Participants — p=0.83

Primary: Number of Sick Days — p=< 0.05

Primary: Safety and Tolerability of DS-01 Treatment vs Placebo — 0; 0 Participants

Primary: Duration of Diarrhea — 2; 2 days — p=0.43

Primary: Development of Diarrhea — 5; 6 participants

Primary: Number of Participants With Stool Sample Acquired — 46 Participants