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Typhoid Vi polysaccharide

Phase 3

Salmonella Infections | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: May 12, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01608815Study of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine in Japanese SubjectsPHASE3 COMPLETED 200 — — May 1, 2012Dec 1, 2012May 12, 20143 Japan
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Study Endpoints
Primary Endpoints
Number of Participants With At Least a 4-Fold Rise in Vi Antibody Titers Following Vaccination With a Typhoid Vi Polysaccharide Vaccine
Day 0 (pre-vaccination) to Day 28 (post-vaccination)

Anti Vi antibodies were measured by Enzyme-Linked ImmunoSorbent Assay (ELISA).

Secondary Endpoints
Geometric Mean Titers (GMTs) of Antibodies to Vi Antibody Before and Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
Day 0 (pre-vaccination) and Day 28 post-vaccination
Geometric Mean Titer Ratios (GMTRs) of Antibodies to Vi Antibody Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
Day 28 post-vaccination
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
Day 0 up to Day 7 post-vaccination
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Study GroupEXPERIMENTALAll participants will receive single dose of typhoid Vi polysaccharide vaccine on Day 0.
Interventions
NameTypeDescription
Typhoid Vi polysaccharideBIOLOGICAL0.5 mL, Intramuscular
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Eligibility Criteria
Age Range2 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Aged 2 years and above on the day of inclusion * For subjects ≥ 20 years of age: Informed consent form has been signed and dated by the subjects. For subjects 2 to 19 years of age: Informed consent form has been signed and dated by the parent or other legally representative. A...

Countries:Japan
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