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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00856297 | Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine | PHASE3 | COMPLETED | 389 | — | — | Feb 1, 2009 | Nov 1, 2012 | Jun 14, 2017 | 32 | United States |
| NCT00310817 | Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months. | PHASE2 | COMPLETED | 623 | — | — | Mar 1, 2005 | May 1, 2006 | Nov 6, 2015 | 2 | Finland, Poland |
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.
| 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. |
| 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...