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Novartis MenACWY-CRM · 1 trial · 2 indications
Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y by serum bactericidal assay using human complement, human serum bactericidal assay (hSBA), at day 29 (28 days after MenACWY-CRM vaccination). Seroresponse is defined as: 1. for subjects with a pre-vaccination hSBA titer \< 1:4, a postvaccination hSBA titer ≥ 1:8. 2. for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.
| Arm | Type | Description |
|---|---|---|
| MenACWY-CRM | EXPERIMENTAL | Subjects received one dose of MenACWY-CRM conjugate vaccine. |
| Placebo | PLACEBO_COMPARATOR | Subjects received the saline placebo. |
| Name | Type | Description |
|---|---|---|
| Novartis MenACWY-CRM | BIOLOGICAL | All subjects had blood drawn at Day 1 and Day 29. |
| Saline Placebo | BIOLOGICAL | All subjects had blood drawn at Day 1 and Day 29. |
Inclusion Criteria: Individuals eligible for enrollment in this study were those: 1. who were 11-55 years of age inclusive and who, after the nature of the study had been explained: 1. had given written assent and/or for whom the parent/legal representative had provided written informed consen...
Novartis MenACWY-CRM is an investigational vaccine being studied for the prevention of meningococcal disease, including meningococcal meningitis. It is intended for use in adolescents and adults, and it is currently in Phase 3 clinical development.
Novartis MenACWY-CRM is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the vaccine's immunogenicity and safety.
Novartis MenACWY-CRM is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the vaccine remains under evaluation for its safety and effectiveness.
Novartis MenACWY-CRM has been studied in a Phase 3 clinical trial registered as NCT01274897. This was a multicenter, observer-blind, placebo-controlled, randomized study that evaluated the immunogenicity and safety of the vaccine in adolescents and adults in South Korea.
Novartis MenACWY-CRM is a specific vaccine candidate that targets meningococcal disease. It is designed to protect against the same disease as other MenACWY vaccines, but it is a distinct product being developed by Novartis AG. The vaccine is currently in Phase 3 clinical trials.