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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01890759 | Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federation | PHASE3 | COMPLETED | 300 | — | — | Jun 25, 2013 | Apr 12, 2016 | Apr 19, 2022 | 8 | India, Russia |
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. Seroprotection was defined as antibody titers ≥ 1:8.
| Arm | Type | Description |
|---|---|---|
| Meningococcal Diphtheria Toxoid Vaccine | EXPERIMENTAL | Participants at age 9 to 17 months of enrollment will receive 2 doses on Menactra vaccine at 3 to 6 months apart |
| Name | Type | Description |
|---|---|---|
| Meningococcal Diphtheria Toxoid Vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: * Male and female subjects aged 9 to 17 months on the day of inclusion * Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative(s) (if applicable) * Subject and parent/legally acceptable representative (if applicable) able to ...