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Vi-CRM197 vaccine · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Vi-CRM, Older infants | EXPERIMENTAL | Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine |
| PNC13, Older infants | ACTIVE_COMPARATOR | Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine |
| Vi-CRM, Infants | EXPERIMENTAL | Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine |
| PNC13, Infants | ACTIVE_COMPARATOR | Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine |
| Vi-CRM, Children | EXPERIMENTAL | Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine |
| Vi-PS, Children | ACTIVE_COMPARATOR | Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine |
| Vi-CRM, Adults | EXPERIMENTAL | Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine |
| Vi-PS, Adults | ACTIVE_COMPARATOR | Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine |
| Name | Type | Description |
|---|---|---|
| Vi-CRM197 vaccine | BIOLOGICAL | - |
| Pneumococcal conjugate vaccine | BIOLOGICAL | - |
| Vi Polysaccharide (PS) vaccine | BIOLOGICAL | - |
Inclusion criteria: * Subjects belonging to 3 age groups will be enrolled into the trial: children (24 to 59 months of age at enrollment), older infants (9 to 12 months of age at enrollment) and infants (6 weeks of age at enrolment). * Written informed consent will be obtained by the parents/ guard...
Vi-CRM197 vaccine is being developed for the prevention of typhoid fever, an infectious disease caused by Salmonella Typhi. It is a vaccine candidate studied in healthy volunteers, including infants, older infants, children, and adults. It is intended to protect against S. Typhi infection.
Vi-CRM197 vaccine is being developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical trials evaluating this vaccine candidate for typhoid fever prevention.
Vi-CRM197 vaccine is in Phase 2 clinical development. Two Phase 2 trials have been completed, and no active trials are currently listed. The vaccine remains investigational and has not been approved for use.
Vi-CRM197 vaccine has been evaluated in two completed Phase 2 trials. NCT01437267 studied safety and immunogenicity in children, older infants, and infants in the Philippines with 120 participants. NCT01229176 studied safety and immunogenicity in adults, children, older infants, and infants in India and Pakistan with 200 participants.
Vi-CRM197 vaccine is a conjugate vaccine that combines the Vi polysaccharide antigen of Salmonella Typhi with the carrier protein CRM197. This design aims to generate an immune response against S. Typhi. The vaccine is administered to healthy volunteers to assess safety and immunogenicity.