Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01547715 | Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 75 Years of Age in India | PHASE3 | COMPLETED | 180 | — | — | Mar 1, 2012 | Apr 1, 2014 | Oct 9, 2018 | 4 | India |
| NCT01410474 | Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 18 Years in Taiwan | PHASE3 | COMPLETED | 341 | — | — | Aug 1, 2011 | Jan 1, 2012 | Sep 22, 2014 | 3 | China |
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.
| 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 | - |
| Name | Type | Description |
|---|---|---|
| Meningococcal ACWY conjugate vaccine | BIOLOGICAL | All subjects received a single dose of Meningococcal ACWY conjugate vaccine |
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 (...