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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07320716 | Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children | PHASE2 | NOT YET_RECRUITING | 528 | — | — | Jan 2, 2026 | Oct 31, 2028 | Jan 6, 2026 | - | — |
S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes will be tested.
S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes will be tested.
| Arm | Type | Description |
|---|---|---|
| H06_01TP Study_Infants_Selected dose | EXPERIMENTAL | Infants who received 3 doses of the altSonflex1-2-3 vaccine on Day 1, Day 85, and Day 253 in the H06\_01TP parent study. |
| H06_01TP Study_ ST2_Infants_Control | ACTIVE_COMPARATOR | Infants who received 2 doses of the Menveo vaccine on Day 1 and Day 85, and 1 dose of the Infanrix hexa vaccine on Day 281 in the H06\_01TP parent study. |
| H06_02TP Study_Infants_Selected dose | EXPERIMENTAL | Infants who received 2 doses of the altSonflex1-2-3 vaccine on Day 1 and Day 169 in the H06\_02TP parent study. |
| H06_02TP Study_ Infants_Control | ACTIVE_COMPARATOR | Infants who received 1 dose of the TYPHIBEV vaccine on Day 1 and 1 dose of the Infanrix hexa vaccine on Day 169 in the H06\_02TP parent study. |
| Name | Type | Description |
|---|---|---|
| AltSonflex1-2-3 | BIOLOGICAL | No intervention is administered in this extension study. The selected dose of altSonflex1-2-3 vaccine was administered intramuscularly in the participants' thigh during the H06\_01TP (212149) parent study on Day 1, Day 85, and Day 253; or on Day 1 and Day 169 during the H06\_02TP (219449) study. |
| Menveo | BIOLOGICAL | No intervention is administered in this extension study. The Menveo vaccine was administered intramuscularly in the participants' thigh on Day 1 and Day 85 during the H06\_01TP (212149) parent study. |
| Infanrix hexa | BIOLOGICAL | No intervention is administered in this extension study. The Infanrix hexa vaccine was administered intramuscularly in the participants' thigh on Day 281 during the H06\_01TP (212149) study; or on Day 169 during the H06\_02TP (219449) parent study. |
| TYPHIBEV | BIOLOGICAL | No intervention is administered in this extension study. The TYPHIBEV vaccine was administered intramuscularly in the participants' thigh on Day 1 during the H06\_02TP (219449) parent study. |
Inclusion Criteria: * Children who, as infants, previously participated in two completed studies (H06\_01TP or H06\_02TP) and were vaccinated with 3 or 2 doses of altSonflex1-2-3 or control vaccines, respectively, completed all previous vaccinations and are 12±1 months after the last altSonflex1-2-...