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MenC-CRM LIQ · 1 trial · 2 indications
Immunogenicity was measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs)against N meningitidis type C, at day 29 after a single vaccination when administered to toddlers to assess the equivalence of MenC-CRM LIQ to MenC-CRM EMV and MenC-CRM ROS to MenC-CRM EMV.
| Arm | Type | Description |
|---|---|---|
| MenC-CRM LIQ (Liquid Formulation) | EXPERIMENTAL | Subjects received 1 injection of MenC-CRM vaccine,liquid formulation. |
| MenC-CRM ROS (Rosia) | EXPERIMENTAL | Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy |
| MenC-CRM EMV (Emeryville) | ACTIVE_COMPARATOR | Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA |
| Name | Type | Description |
|---|---|---|
| MenC-CRM LIQ | BIOLOGICAL | One dose of MenC-CRM vaccine, liquid formulation |
| MenC-CRM ROS | BIOLOGICAL | One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy. |
| MenC-CRM EMV | BIOLOGICAL | One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA. |
Inclusion Criteria: 1. Healthy 12 - 23 (inclusive) month-old male or female toddlers. 2. A parent/legal guardian was given written informed consent after the nature of the study has been explained. 3. Available for both the visits scheduled in the study. 4. In good health as determined by medical h...
MenC-CRM LIQ is an investigational vaccine being studied for the prevention of meningococcal disease, including meningococcal meningitis. It is a liquid formulation of a meningococcal C conjugate vaccine. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
MenC-CRM LIQ is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational meningococcal C conjugate vaccine.
MenC-CRM LIQ is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy. The drug is being studied for the prevention of meningococcal disease.
MenC-CRM LIQ has one completed Phase 2 clinical trial registered under NCT01434680. This trial, titled "Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers," enrolled 992 participants in Poland and evaluated the vaccine in healthy toddlers aged 12 months and older.
MenC-CRM LIQ is a meningococcal C conjugate vaccine designed to elicit an immune response against Neisseria meningitidis serogroup C. By presenting the capsular polysaccharide of the bacteria conjugated to a carrier protein, the vaccine aims to induce protective antibodies that can prevent meningococcal disease.