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Typherix

Phase 1

Typhoid Fever | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Jan 17, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

Typherix · 1 trial · 1 indication

Phase 1 1
NCT01123941Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old)Typhoid Fever
COMPLETED50 Analytics
PHASE1COMPLETED
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old)
Typhoid FeverUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Subjects Reporting Any Post Immunization Reactions
During the 7-day period after vaccination

Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia and fatigue.

Number of Subjects Reporting Adverse Events
During the 28-day period after vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs)
During the 6-month period after vaccination

Secondary Endpoints

Anti-Vi ELISA Geometric Mean Concentration (GMC)
At 28 days after vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
NVGH Vi-CRM197 conjugate vaccineEXPERIMENTAL -
Vi-polysaccharide vaccineACTIVE_COMPARATOR -

Interventions

NameTypeDescription
TypherixBIOLOGICAL1 dose, 0.5 mL containing 25 mcg of Vi polysaccharide
NVGH Vi-CRM197BIOLOGICAL1 dose of 0.5 mL containing 25 mcg of Vi-CRM
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Males and females of age ≥18 to ≤40 years. 2. Individuals who, after the nature of the study has been explained to them, have given written consent according to local regulatory requirements. 3. Individuals in good health as determined by the outcome of medical history, physi...

Countries:Belgium
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Frequently asked questions about Typherix

What is Typherix used for?

Typherix is an investigational monoclonal antibody being developed for the prevention of typhoid fever, an infectious disease caused by Salmonella Typhi. It is currently in Phase 1 clinical development and has not been approved for use. The drug is being studied for its safety and immunogenicity in adult populations.

Who makes Typherix?

Typherix is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's potential as a preventive treatment for typhoid fever.

What phase is Typherix in?

Typherix is currently in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The Phase 1 trial has been completed, and the drug is not yet available for clinical use outside of research settings.

What clinical trials is Typherix in?

Typherix has one completed Phase 1 clinical trial registered under NCT01123941, titled 'Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old)'. The trial enrolled 50 healthy adult volunteers in Belgium and was an active-controlled, randomized study.

Is Typherix the same as a vaccine?

Typherix is a monoclonal antibody, not a traditional vaccine. However, the completed clinical trial NCT01123941 evaluated a Vi-CRM197 vaccine against Salmonella Typhi, which may be related to the Typherix development program. The drug is being studied for its ability to prevent typhoid fever.

How does Typherix work?

Typherix is a monoclonal antibody designed to target components of Salmonella Typhi, the bacterium that causes typhoid fever. By binding to specific antigens, it may help the immune system neutralize the pathogen and prevent infection. The exact molecular target has not been disclosed in available information.