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Typhoid Vi polysaccharide

Phase 3

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

Success Probability

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

Typhoid Vi polysaccharide · 1 trial · 3 indications

Phase 3 1
NCT01608815Study of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine in Japanese SubjectsSalmonella Infections
COMPLETED200 Analytics
PHASE3COMPLETED
Study of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine in Japanese Subjects
Salmonella Infections
NCT01608815200
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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 to 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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Frequently asked questions about Typhoid Vi polysaccharide

What is Typhoid Vi polysaccharide used for?

Typhoid Vi polysaccharide is used for Salmonella infections, specifically typhoid fever. It is a vaccine being developed by Sanofi to protect against bacterial infections caused by Salmonella. The drug is currently in Phase 3 clinical development and is being studied in Japanese subjects.

What does Typhoid Vi polysaccharide target?

Typhoid Vi polysaccharide targets the Vi capsular polysaccharide of Salmonella Typhi, the bacterium that causes typhoid fever. By eliciting an immune response against this polysaccharide, the vaccine aims to provide protection against Salmonella infections.

Who makes Typhoid Vi polysaccharide?

Typhoid Vi polysaccharide is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in Japanese subjects.

What phase is Typhoid Vi polysaccharide in?

Typhoid Vi polysaccharide is in Phase 3 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the vaccine is being studied for the prevention of typhoid fever.

What clinical trials is Typhoid Vi polysaccharide in?

Typhoid Vi polysaccharide has one completed Phase 3 clinical trial, identified as NCT01608815. This study evaluated a single dose of the SP093 Typhoid Vi polysaccharide vaccine in 200 Japanese subjects aged 2 years and older. The trial was uncontrolled and not blinded.

Is Typhoid Vi polysaccharide the same as SP093?

Typhoid Vi polysaccharide is also known as SP093. In clinical trial NCT01608815, the vaccine is referred to as SP093 Typhoid Vi polysaccharide vaccine, indicating that SP093 is the investigational name for this vaccine candidate.