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Also known as MenACWY-CRM conjugate vaccine
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, adjuvanted is used for the prevention of meningococcal disease, including meningococcal meningitis. It is a vaccine developed by Novartis AG that is designed to protect against meningococcal infection. The asset is in Phase 3 clinical development.
MenACWY-CRM conjugate vaccine, adjuvanted is developed by Novartis AG, which trades under the ticker NVS. Novartis conducted the clinical program for this meningococcal vaccine candidate, including Phase 2 and Phase 3 studies in adolescents and children.
MenACWY-CRM conjugate vaccine, adjuvanted is in Phase 3 clinical development. It is an investigational vaccine and is not approved. Two completed trials are recorded for the asset, with no active trials currently listed, and total enrollment across the program is 1,012 participants.
The program includes NCT00856297, a Phase 3 study evaluating persistence of anti-meningococcal bactericidal antibodies in adolescents who previously received MenACWY conjugate vaccine, and NCT00310817, a Phase 2 safety and immunogenicity study in healthy children aged 12 to 59 months. A third study, NCT00262041, was a Phase 2 trial in healthy adolescents.
Yes. MenACWY-CRM conjugate vaccine, adjuvanted is also known as MenACWY-CRM conjugate vaccine. The two names refer to the same Novartis AG meningococcal vaccine candidate in Phase 3 development for the prevention of meningococcal disease and meningococcal meningitis.
The trials for MenACWY-CRM conjugate vaccine, adjuvanted were randomized, double-blind, and active-controlled. They enrolled healthy volunteers, including adolescents from 11 years of age and children from 12 months of age, and were conducted in the United States, Finland, and Poland.