Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01123941 | Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old) | PHASE1 | COMPLETED | 50 | — | — | May 1, 2010 | Nov 1, 2010 | Jan 17, 2014 | 1 | Belgium |
Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia and fatigue.
| Arm | Type | Description |
|---|---|---|
| NVGH Vi-CRM197 conjugate vaccine | EXPERIMENTAL | - |
| Vi-polysaccharide vaccine | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Typherix | BIOLOGICAL | 1 dose, 0.5 mL containing 25 mcg of Vi polysaccharide |
| NVGH Vi-CRM197 | BIOLOGICAL | 1 dose of 0.5 mL containing 25 mcg of Vi-CRM |
Inclusion Criteria: 1. Males and females of age ≥18 to ≤40 years. 2. Individuals who, after the nature of the study has been explained to them, have given written consent according to local regulatory requirements. 3. Individuals in good health as determined by the outcome of medical history, physi...