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Shanchol: Cholera Vaccine Killed Bivalent Whole Cell

Phase 3

Cholera | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Mar 26, 2018

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment336

FDA Designations

No designations recorded

Clinical trial landscape

Shanchol: Cholera Vaccine Killed Bivalent Whole Cell · 1 trial · 1 indication

Phase 3 1
NCT02434822A Study of Two Doses of Oral Cholera Vaccine (Shanchol™) in Subjects Aged 1 Year and Older in Dominican RepublicCholera
COMPLETED336 Analytics
PHASE3COMPLETED
A Study of Two Doses of Oral Cholera Vaccine (Shanchol™) in Subjects Aged 1 Year and Older in Dominican Republic
Cholera
NCT02434822336
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Study Endpoints

Primary Endpoints

Number of participants reporting unsolicited systemic adverse events (AEs); solicited systemic reactions including serious adverse events following administration Oral Cholera Vaccine (Shanchol™)
Day 0 up to Day 44 post oral vaccination

Solicited systemic reaction: Vomiting, Diarrhea, Fever (temperature), Abdominal pain, Itching, Rash, Weakness, Cough, Vertigo, and Dryness of Mouth

Summary of titers of serum vibriocidal antibodies Before and 14 days after each Oral Cholera Vaccine (Shanchol™)
Day 0 (before) and Day 14 Post oral vaccination

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.

Secondary Endpoints

Number of participants with 4-fold or greater rises in titers 14 days after each Oral Cholera Vaccine (Shanchol™) relative to baseline
Day 0 (before) and Day 14 Post oral vaccination
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Study Group 1EXPERIMENTALParticipants aged 1 through 4 years at enrollment
Study Group 2EXPERIMENTALParticipants aged 5 through 14 years at enrollment
Study Group 3EXPERIMENTALParticipants aged 15 years and above at enrollment

Interventions

NameTypeDescription
Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole CellBIOLOGICAL1.5 mL, Oral administration
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Eligibility Criteria

Age Range1 Year to N/A
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:Dominican Republic
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