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MenACWY-CRM conjugate vaccine, adjuvanted · 3 trials · 2 indications
Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with human complement serum bactericidal activity (hSBA) titers≥ 1:8 directed against N meningitidis serogroups A, C, W and Y.
Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
Immune response of a single dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant compared to that of one dose of MenACWY polysaccharide (PS) vaccine, one month after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with hSBA titers \>1:4 directed against N meningitidis serogroups A, C, W and Y
| Arm | Type | Description |
|---|---|---|
| MenACWY-CRM | EXPERIMENTAL | Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study. |
| Licensed comparator | ACTIVE_COMPARATOR | Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination. |
| Naive | OTHER | Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations. |
| MenACWY-CRM/MenACWY-CRM | EXPERIMENTAL | Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination. |
| Licensed comparator/MenACWY-CRM | EXPERIMENTAL | Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination. |
| MenACWY-CRM(Ad+) 12 to 35 Months | EXPERIMENTAL | Subjects received one dose of MenACWY-CRM conjugate vaccine with adjuvant (Ad+) on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination. |
| MenACWY-CRM(Ad-) 12 to 35 Months | EXPERIMENTAL | Subjects received one dose of MenACWY-CRM conjugate vaccine without adjuvant (Ad-) on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination. |
| MenACWY-CRM(Ad-) 36 to 59 Months | EXPERIMENTAL | Subjects received one dose of MenACWY-CRM conjugate vaccine without adjuvant on day 1 and second dose on day 169 or day 337. |
| MenACWY-PS (36 to 59 Months) | ACTIVE_COMPARATOR | Subjects received one dose of MenACWY polysaccharide (PS) vaccine on day 1 and second dose of MenACWY-CRM conjugate vaccine without adjuvant on day 169 or day 337. |
| MenACWY-CRM(Ad+) | EXPERIMENTAL | Subjects received one single dose of adjuvanted formulation of conjugate vaccine. |
| MenACWY-CRM(Ad-) | EXPERIMENTAL | Subjects received one single dose of unadjuvanted formulation of conjugate vaccine. |
| MenACWY- PS | ACTIVE_COMPARATOR | Subjects received one single dose of the polysaccharide vaccine. |
| Name | Type | Description |
|---|---|---|
| MenACWY-CRM conjugate vaccine | BIOLOGICAL | - |
| Licensed comparator | BIOLOGICAL | - |
| MenACWY-CRM conjugate vaccine, adjuvanted | BIOLOGICAL | - |
| MenACWY polysaccharide vaccine | BIOLOGICAL | - |
| MenACWY-CRM conjugate vaccine, unadjuvanted | BIOLOGICAL | - |
Inclusion Criteria: Subjects enrolled in V59P13: * healthy subjects who have completed the V59P13 study. Naïve subjects: * healthy subjects aged-matched with subjects who had completed the V59P13 trial.(currently 16-23 years old). Exclusion Criteria: Subjects who had completed the V59P13 study...
MenACWY-CRM conjugate vaccine is used for the prevention of meningococcal disease, meningococcal meningitis, and N. meningitidis carriage. It is an investigational vaccine being developed by Novartis AG for these infectious disease indications.
MenACWY-CRM conjugate vaccine is being developed by Novartis AG, which trades under the ticker NVS. The vaccine is currently in clinical development for the prevention of meningococcal disease and related conditions.
MenACWY-CRM conjugate vaccine is in Phase 3 clinical development. It has completed two Phase 3 trials, including a carriage trial and a persistence study, along with two earlier Phase 2 trials.
MenACWY-CRM conjugate vaccine has completed four clinical trials. These include NCT00262041 and NCT00310817 in Phase 2, and NCT00856297 and NCT01214850 in Phase 3, covering adolescents, children, and adults in multiple countries.
Yes, MenACWY-CRM conjugate vaccine is the same as the Novartis Meningococcal ACWY Conjugate Vaccine. Clinical trials refer to it by both names, with the vaccine being evaluated for safety and immunogenicity across different age groups.