Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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, a serious infectious disease caused by Salmonella Typhi. It is currently in Phase 2 clinical development and is not yet approved for use.
NVGH Vi-CRM197 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The vaccine is currently in Phase 2 clinical trials for typhoid fever.
NVGH Vi-CRM197 is in Phase 2 clinical development. It is an investigational vaccine for typhoid fever and has not been approved by regulatory authorities. Two Phase 2 trials have been completed, with a total of 139 participants enrolled.
NVGH Vi-CRM197 has been studied in two completed Phase 2 clinical trials. The first, NCT01193907, evaluated the safety and immunogenicity of three formulations in 88 adults aged 18-40 in Belgium. The second, NCT01438996, was an extension study assessing booster response in 51 adults.
NVGH Vi-CRM197 is also referred to as Vi-CRM197 in clinical trial documentation. The vaccine is a conjugate vaccine designed to protect against typhoid fever, and it is currently in Phase 2 development by Novartis AG.