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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02139228 | Persistency Study After Hib-CRM (Cross-Reacting Material)197 or Hib-TT (Tetanus Toxoid) Vaccines in Chinese Children | PHASE3 | COMPLETED | 426 | — | — | Nov 1, 2014 | Jan 1, 2015 | Nov 9, 2015 | 1 | China |
Immunogenicity was measured as geometric mean of Anti- PRP Concentrations, approximately 4 years after booster vaccination with either Hib-CRM197 or Hib-TT in children participating in previous V37\_07E1 trial.
| Arm | Type | Description |
|---|---|---|
| Hib CRM197 | EXPERIMENTAL | Subjects treated with 3 doses of CRM 197 -conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37\_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37\_07E1 (NCT01226953). No vaccine was administered during this trial |
| Hib TT | ACTIVE_COMPARATOR | Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37\_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37\_07E1 (NCT01226953). No vaccine was administered during this trial |
| Name | Type | Description |
|---|---|---|
| Hib-CRM197 | BIOLOGICAL | No vaccine administered in V37\_07E2 study |
| Hib-TT | BIOLOGICAL | No vaccine administered in V37\_07E2 study |
Inclusion Criteria: 1. Children previously enrolled in V37\_07E1 study and who received the appropriate vaccination. 2. Children whose parent(s) or legal guardian(s) had given written consent after the nature of the study was explained according to local regulatory requirements. Exclusion Criteria...