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Meningococcal ACWY Conjugate Vaccine · 4 trials · 4 indications
The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup A. Seroresponse is defined as: * For subjects with a pre-vaccination hSBA titer \<1:4, a postvaccination hSBA titer≥1:8 * For subjects with a pre-vaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.
The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup C.
The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup W.
The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup Y.
Immunogenicity was measured as the percentage of subjects with hSBA seroresponse and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at 28 days after one vaccination of MenACWY-CRM (day 29). Seroresponse is defined as: 1. for subjects with a prevaccination hSBA titer \<1:4, a postvaccination hSBA titer ≥1:8. 2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
Immunogenicity as measured by percentage of subjects with hSBA titer \>=1:8 directed against N. meningitidis serogroups A, C, W and Y; after four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age
Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.
To demonstrate that the immunogenicity of one injection of Tdap vaccine, concomitantly administered with MenACWY-CRM vaccine, is not inferior to that of one injection of Tdap vaccine, concomitantly administered with saline placebo, in terms of 1. the percentage of subjects with antibody levels against diphtheria toxin ≥ 1.0 IU/mL and against tetanus toxin ≥ 1.0 IU/mL and 2. the percentage of subjects with at least 4 fold increase in antibody levels against pertussis toxin (PT), filamentous hemagglutinin (FHA) and pertactin (PRN) at 1 month after immunization, as measured by enzyme linked immunosorbent assay (ELISA).
| Arm | Type | Description |
|---|---|---|
| MenACWY - 2 - 10 Years old | EXPERIMENTAL | Subjects between 2 and 10 years of age who received one injection of Meningococcal ACWY conjugate vaccine -CRM vaccine on day 1. |
| MenACWY - 11 - 18 Years old | EXPERIMENTAL | Subjects between 11 and 18 years of age who received one injection of Meningococcal ACWY conjugate vaccine-CRM vaccine on day 1. |
| MenACWY - 19 - 75 Years old | EXPERIMENTAL | Subjects between 11 and 18 years of age who received one injection of Meningococcal ACWY conjugate vaccine-CRM vaccine on day 1. |
| 2-18 years | EXPERIMENTAL | - |
| US1A (MenACWY-CRM + Infant Vaccines) | EXPERIMENTAL | Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| US1B (MenACWY-CRM + Infant Vaccines) | EXPERIMENTAL | Received vaccines: MenACWY: 2, 4, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| US2 (Infant Vaccines Only) | EXPERIMENTAL | Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| US3 (MenACWY-CRM + Infant Vaccines) | EXPERIMENTAL | Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| US4A (Infant Vaccines Only) | EXPERIMENTAL | Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| US4B (Infant Vaccines Only) | EXPERIMENTAL | Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| US4C (Infant Vaccines Only) | EXPERIMENTAL | Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| LA1A (MenACWY-CRM + Infant Vaccines) | EXPERIMENTAL | Received vaccines: MenACWY: 2, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| LA1B (MenACWY-CRM + Infant Vaccines) | EXPERIMENTAL | Received vaccines: MenACWY: 2, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| LA2 (Infant Vaccines Only) | EXPERIMENTAL | Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| LA3A (MenACWY-CRM + Infant Vaccines) | EXPERIMENTAL | Received vaccines: MenACWY: 2, 4, 6, and 16 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months |
| LA3B (MenACWY-CRM + Infant Vaccines) | EXPERIMENTAL | Received vaccines: MenACWY: 2, 4, 6, and 17 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months |
| LA4 (Infant Vaccines Only) | EXPERIMENTAL | Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 15 months Pneumococcal, HAV, and MMR-V: 12 months |
| LA5 (MenACWY-CRM + Infant Vaccines) | EXPERIMENTAL | Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| LA6A (Infant Vaccines Only) | EXPERIMENTAL | Received vaccines: MenACWY: 12, and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| LA6B (Infant Vaccines Only) | EXPERIMENTAL | Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| LA6C (Infant Vaccines Only) | EXPERIMENTAL | Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| Tdap + MenACWY-CRM | EXPERIMENTAL | Subjects received Tdap and MenACWY-CRM vaccines concomitantly, in separate arms |
| Tdap + saline | EXPERIMENTAL | Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms |
| MenACWY-CRM + saline | EXPERIMENTAL | Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms |
| Name | Type | Description |
|---|---|---|
| Meningococcal ACWY conjugate vaccine | BIOLOGICAL | All subjects received a single dose of Meningococcal ACWY conjugate vaccine |
| DTaP-IPV-HBV | BIOLOGICAL | - |
| Hib | BIOLOGICAL | - |
| Rotavirus | BIOLOGICAL | - |
| Pneumococcal 7-valent Conjugate Vaccine | BIOLOGICAL | - |
| HAV | BIOLOGICAL | - |
| MMR-V | BIOLOGICAL | - |
| DTaP | BIOLOGICAL | - |
| Meningococcal ACWY conjugate vaccine (MenACWY-CRM) | BIOLOGICAL | - |
| Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap) | BIOLOGICAL | - |
| saline placebo | BIOLOGICAL | 4.5 mg sodium chloride per 0.5 ml dose |
Inclusion Criteria: Individuals eligible for enrollment in this study are those: 1. who are of any gender, from the age of 2 to 75 years at the time of visit 1, and to whom the nature of the study has been explained and: * the parent/legal representative has provided written informed consent (...
Meningococcal ACWY Conjugate Vaccine is used to prevent meningococcal disease, including meningitis and bacterial meningitis. It is an investigational vaccine being developed for protection against Neisseria meningitidis serogroups A, C, W, and Y. The vaccine is intended for use in healthy individuals, with clinical trials evaluating its safety and immune response.
Meningococcal ACWY Conjugate Vaccine is being developed by Novartis AG, a company traded on the New York Stock Exchange under the ticker symbol NVS. The vaccine is currently in Phase 3 clinical development for the prevention of meningococcal disease, including meningitis and bacterial meningitis.
Meningococcal ACWY Conjugate Vaccine is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory authorities. The Phase 3 trials have been completed, and the vaccine is being studied for its immunogenicity and safety in various age groups, from infants to adults.
Meningococcal ACWY Conjugate Vaccine has completed four Phase 3 clinical trials. These include NCT00329901, which studied concomitant administration with a Tdap vaccine in subjects aged 11-25 years in Italy, and NCT00474526, which evaluated safety and immune response in infants in the United States, Argentina, and Colombia. Additional trials NCT01410474 and NCT01547715 assessed immunogenicity and safety in subjects from 2 to 18 years in Taiwan and from 2 to 75 years in India, respectively.
Meningococcal ACWY Conjugate Vaccine is a conjugate vaccine designed to elicit an immune response against Neisseria meningitidis serogroups A, C, W, and Y. By presenting polysaccharide antigens conjugated to a carrier protein, it stimulates the production of protective antibodies, helping to prevent meningococcal disease, including meningitis and bacterial meningitis.