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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04084769 | Study to Evaluate the Immune Response After a Booster Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine When Administered Alone or Concomitantly With a Licensed Meningococcal Serogroup B Vaccine, in Participants Who Received Primary Quadrivalent Meningococcal Conjugate Vaccine (MCV4) | PHASE3 | COMPLETED | 570 | — | — | Sep 3, 2019 | Sep 14, 2020 | Sep 15, 2025 | 30 | United States, Puerto Rico |
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by Serum Bactericidal Assay Using Human Complement (hSBA). The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titer less than (\<) 1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>= 1:8. Immune response was considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of participants with hSBA seroresponse against serogroups A, C, Y and W was greater than 75%.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \>=1:16 for participants with pre-vaccination hSBA titer \<1:8, or a \>=4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8. Immune response was considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of participants with hSBA seroresponse against serogroups A, C, Y and W was greater than 75%.
| Arm | Type | Description |
|---|---|---|
| Group 1: MenACYW Conjugate vaccine | EXPERIMENTAL | Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 (NCT02199691) or MET43 (NCT02842853), received a single intramuscular (IM) dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59). |
| Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed) | EXPERIMENTAL | Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59). |
| Group 3: MenACYW Conjugate vaccine + Trumenba vaccine | EXPERIMENTAL | Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59). |
| Group 4: MenACYW Conjugate vaccine + Bexsero vaccine | EXPERIMENTAL | Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59). |
| Name | Type | Description |
|---|---|---|
| Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine | BIOLOGICAL | Pharmaceutical form: Solution for injection Route of administration: IM |
| Meningococcal Group B vaccine (Trumenba®) | BIOLOGICAL | Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM |
| Meningococcal group B vaccine (Bexsero®) | BIOLOGICAL | Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM |
Inclusion criteria : * Aged \>= 13 to less than (\<) 26 years on the day of inclusion. * Participants participated in and completed study MET50 (MET50 Groups 1, 2, or 3 only) or study MET43 (MET43 Groups 1, 2, or 3 only). * For MET59 Group 2 only (Menveo vaccine-primed participants only; enrichment...