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Shanchol: Cholera Vaccine Killed Bivalent Whole Cell · 1 trial · 1 indication
Solicited systemic reaction: Vomiting, Diarrhea, Fever (temperature), Abdominal pain, Itching, Rash, Weakness, Cough, Vertigo, and Dryness of Mouth
Serum vibriocidal antibody (against V. cholerae O1 Inaba serogroup, V. cholerae O1 Ogawa serogroup, and V. cholerae O139 serogroup) will be assessed using the microtiter technique.
| Arm | Type | Description |
|---|---|---|
| Study Group 1 | EXPERIMENTAL | Participants aged 1 through 4 years at enrollment |
| Study Group 2 | EXPERIMENTAL | Participants aged 5 through 14 years at enrollment |
| Study Group 3 | EXPERIMENTAL | Participants aged 15 years and above at enrollment |
| Name | Type | Description |
|---|---|---|
| Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell | BIOLOGICAL | 1.5 mL, Oral administration |
Inclusion Criteria: * Aged 1 year and older on the day of inclusion * Subjects aged 1 through 17 years: Informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and assent form has been signed and dated by the subject if aged 9 through 17 years S...
Shanchol is an oral cholera vaccine made of killed bivalent whole cells. It is given to prevent cholera, an infectious disease. The vaccine is developed by Sanofi, which trades under the ticker SNY. It is a vaccine modality rather than a small molecule or biologic therapeutic.
Shanchol is used to prevent cholera, an infectious disease. It is an oral vaccine containing killed bivalent whole cells. The vaccine is given in two doses, and it has been studied in subjects aged 1 year and older. It is developed by Sanofi under the ticker SNY.
Shanchol is developed by Sanofi, which trades under the ticker SNY. Sanofi is the company behind the killed bivalent whole cell oral cholera vaccine. The vaccine has been evaluated in a Phase 3 study conducted in the Dominican Republic.
Shanchol is in Phase 3 development for cholera. One Phase 3 trial of the vaccine has been completed, and no trials are currently active. The completed study enrolled 336 participants aged 1 year and older in the Dominican Republic. Shanchol is an investigational vaccine still in clinical development.
Shanchol has been studied in one completed Phase 3 trial, NCT02434822, titled A Study of Two Doses of Oral Cholera Vaccine (Shanchol) in Subjects Aged 1 Year and Older in Dominican Republic. The trial enrolled 336 participants, was controlled, and was conducted in the Dominican Republic. No trials of Shanchol are currently active.