Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AltSonflex1-2-3 · 1 trial · 1 indication
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-...
AltSonflex1-2-3 is an investigational monoclonal antibody being developed for diarrhoea. It is currently in Phase 2 clinical development and is being studied in a trial that evaluates its long-term immunogenicity in African children. The drug is not yet approved and remains under investigation.
AltSonflex1-2-3 is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting a Phase 2 clinical trial to evaluate the drug's long-term immunogenicity in African children with diarrhoea.
AltSonflex1-2-3 is in Phase 2 clinical development. It is an investigational drug for diarrhoea and has not been approved by regulatory authorities. The ongoing Phase 2 trial is designed to assess the long-term immunogenicity of the drug in African children.
AltSonflex1-2-3 is being studied in one Phase 2 clinical trial with the identifier NCT07320716. The trial, titled 'Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children', is not yet recruiting and has a planned enrollment of 528 participants.
Yes, AltSonflex1-2-3 is the same as altSonflex1-2-3. The drug is referred to by both names, with the clinical trial title using the lowercase 'altSonflex1-2-3' format. Both names refer to the same investigational monoclonal antibody for diarrhoea.