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NVGH Vi-CRM197 · 2 trials · 1 indication
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...
NVGH Vi-CRM197 is an investigational vaccine being developed for the prevention of typhoid fever, an infectious disease caused by Salmonella Typhi. It is being studied in healthy adult volunteers. It has not been approved for use, and it remains in clinical development.
NVGH Vi-CRM197 is being developed by Novartis AG, which trades under the ticker NVS. The vaccine candidate is part of the company's infectious disease pipeline and has been studied in Phase 2 clinical trials conducted in Belgium.
NVGH Vi-CRM197 is in Phase 2 clinical development. Two Phase 2 trials have been completed, and no trials are currently active. The vaccine candidate is investigational and has not been approved by the FDA or any other regulatory agency.
NVGH Vi-CRM197 has been evaluated in two completed Phase 2 trials. NCT01193907 tested the safety and immunogenicity of three formulations in adults aged 18 to 40. NCT01438996 was an extension study evaluating the booster response induced by Vi-CRM197 in adults. Both trials were conducted in Belgium.
A total of 139 participants have been enrolled across the two completed Phase 2 trials of NVGH Vi-CRM197. NCT01193907 enrolled 88 adults, and NCT01438996 enrolled 51 adults. Both studies were randomized, controlled, and conducted in Belgium with healthy volunteers.