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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01438996 | Extension Study of H01_04TP to Evaluate the Booster Response Induced by Vi-CRM197 in Adults | PHASE2 | COMPLETED | 51 | — | — | Oct 1, 2011 | Dec 1, 2011 | Mar 24, 2014 | 1 | Belgium |
| NCT01193907 | Safety and Immunogenicity of Three Formulations of Vi-CRM197 Vaccine Against S. Typhi in Adults (18-40 Years Old) | PHASE2 | COMPLETED | 88 | — | — | Oct 1, 2010 | Nov 1, 2010 | Jan 17, 2014 | 1 | Belgium |
To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 3 after vaccination as as measured by enzyme-linked immunosorbent assay (ELISA)
To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 7 after vaccination as as measured by ELISA
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-CRM/NVGH Vi-CRM | EXPERIMENTAL | One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01\_04TP study |
| Vi-PS/NVGH Vi-CRM | EXPERIMENTAL | One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01\_04TP study |
| NVGH Vi-CRM | EXPERIMENTAL | One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults |
| NVGH Vi-CRM197 conjugate vaccine 12.5 mcg | EXPERIMENTAL | 1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM |
| NVGH Vi-CRM197 conjugate vaccine 5 mcg | EXPERIMENTAL | 1 dose of 0.5 mL containing 5 mcg of Vi-CRM |
| NVGH Vi-CRM197 conjugate vaccine 1.25 mcg | EXPERIMENTAL | 1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM |
| Typherix | ACTIVE_COMPARATOR | 1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide |
| Name | Type | Description |
|---|---|---|
| NVGH Vi-CRM197 | BIOLOGICAL | Vi-CRM197 glycoconjugated vaccine |
| NVGH Vi-CRM197 12.5 mcg | BIOLOGICAL | 1 dose of 0.5 mL |
| NVGH Vi-CRM197 5.0 mcg | BIOLOGICAL | 1 dose of 0.5 mL |
| NVGH Vi-CRM197 1.25 mcg | BIOLOGICAL | 1 dose of 0.5 mL |
| Vi-polysaccharide vaccine | BIOLOGICAL | 1 dose of 0.5 mL containing 25 mcg of Vi polysaccharide |
Inclusion criteria All Subjects: 1. Males and females of age ≥18 to ≤42 years. 2. Individuals, who, after the nature of the study have been explained to them, have given written consent according to local regulatory requirements. 3. Individuals in good health as determined by the outcome of medica...