Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MenACWY-CRM Vaccine · 1 trial · 1 indication
Number of subjects (2-10 years of age) achieving with hSBA titers ≥1:4 against Neisseria meningitidis serogroups A,C,W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
| Arm | Type | Description |
|---|---|---|
| MenACWY-CRM (2-10 years) | EXPERIMENTAL | Subjects received one dose of investigational MenACWY-CRM conjugate vaccine |
| MenACWY-CRM (12-23 months) | EXPERIMENTAL | Subjects received one dose of investigational MenACWY-CRM conjugate vaccine |
| MenACWY-PS (2-10 years) | ACTIVE_COMPARATOR | Subjects received one dose of licensed comparator MenACWY polysaccharide (MenACWY-PS) vaccine |
| MenACWY-CRM+PnC (12-15 months) | EXPERIMENTAL | Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with PnC |
| MenACWY-CRM+DTaP (16-23 months) | EXPERIMENTAL | Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with DTaP |
| Name | Type | Description |
|---|---|---|
| MenACWY-CRM Vaccine | BIOLOGICAL | - |
| MenACWY-PS Vaccine | BIOLOGICAL | - |
Inclusion Criteria: * Group 1: Healthy children 2-10 years of age; * Group 2: Healthy toddlers 12-23 months of age; who are up to date with age appropriate immunizations for diphtheria, tetanus, pertussis, polio, hepatitis B, Hemophilus influenzae type b, and pneumococcus. Exclusion Criteria: * G...
MenACWY-CRM is an investigational vaccine being developed for the prevention of meningococcal disease, including meningococcal meningitis and other meningococcal infections. It is designed to protect against serogroups A, C, W, and Y of the Neisseria meningitidis bacteria.
MenACWY-CRM is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS.
MenACWY-CRM is in Phase 3 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. All eight clinical trials listed for MenACWY-CRM have been completed, with no active trials currently ongoing.
MenACWY-CRM has been studied in several completed clinical trials, including NCT00262028, NCT00488683, NCT00560313, and NCT01994629. These trials evaluated the safety and immune response of the vaccine in healthy children, infants, and adults across the United States, United Kingdom, and Italy.
MenACWY-CRM is a conjugate vaccine that works by stimulating the immune system to produce antibodies against the Neisseria meningitidis bacteria. It targets the bacterial capsular polysaccharides of serogroups A, C, W, and Y, which are chemically linked to a carrier protein to enhance the immune response.
MenACWY-CRM is also known as Menveo, a meningococcal ACWY conjugate vaccine. The name MenACWY-CRM refers to the CRM197 carrier protein used in the vaccine. This vaccine is designed to prevent invasive meningococcal disease caused by serogroups A, C, W, and Y.