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Vi-CRM197 vaccine

Phase 2

Typhoid Fever | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: May 1, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment320

FDA Designations

No designations recorded

Clinical trial landscape

Vi-CRM197 vaccine · 2 trials · 1 indication

Phase 2 2
NCT01437267Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and InfantsTyphoid Fever
COMPLETED120 Analytics
NCT01229176Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and InfantsTyphoid Fever
COMPLETED200 Analytics
PHASE2COMPLETED
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants
Typhoid Fever
NCT01437267120
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PHASE2COMPLETED
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants
Typhoid Fever
NCT01229176200
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Study Endpoints

Primary Endpoints

Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer
At 28 days after last vaccination as compared to baseline
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer
At 6 months after last vaccination as compared to baseline
Anti-Vi ELISA Geometric Mean Concentration (GMC)
At 28 days after last vaccination
Anti-Vi ELISA GMC
At 6 months after last vaccination

Secondary Endpoints

Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination
During the 7-day follow-up period after vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Vi-CRM, Older infantsEXPERIMENTALOlder Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
PNC13, Older infantsACTIVE_COMPARATOROlder infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
Vi-CRM, InfantsEXPERIMENTALInfants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
PNC13, InfantsACTIVE_COMPARATORInfants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
Vi-CRM, ChildrenEXPERIMENTALChildren (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
Vi-PS, ChildrenACTIVE_COMPARATORChildren (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
Vi-CRM, AdultsEXPERIMENTALAdults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
Vi-PS, AdultsACTIVE_COMPARATORAdults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine

Interventions

NameTypeDescription
Vi-CRM197 vaccineBIOLOGICAL -
Pneumococcal conjugate vaccineBIOLOGICAL -
Vi Polysaccharide (PS) vaccineBIOLOGICAL -
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Eligibility Criteria

Age Range6 Weeks to 59 Months
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria: * Subjects belonging to 3 age groups will be enrolled into the trial: children (24 to 59 months of age at enrollment), older infants (9 to 12 months of age at enrollment) and infants (6 weeks of age at enrolment). * Written informed consent will be obtained by the parents/ guard...

Countries:PhilippinesIndiaPakistan
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Frequently asked questions about Vi-CRM197 vaccine

What is Vi-CRM197 vaccine used for?

Vi-CRM197 vaccine is an investigational vaccine being developed for the prevention of typhoid fever, a bacterial infection caused by Salmonella Typhi. It is intended for use in adults, children, older infants, and infants as young as 6 weeks of age.

Who makes Vi-CRM197 vaccine?

Vi-CRM197 vaccine is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The vaccine is currently in clinical development and is not yet approved for commercial use.

What phase is Vi-CRM197 vaccine in?

Vi-CRM197 vaccine is in Phase 2 clinical development. Two Phase 2 trials have been completed, and the vaccine remains investigational, meaning it has not been approved by regulatory authorities and is still undergoing clinical evaluation for safety and efficacy.

What clinical trials is Vi-CRM197 vaccine in?

Vi-CRM197 vaccine has been studied in two completed Phase 2 trials. NCT01229176 enrolled 200 participants in India and Pakistan, and NCT01437267 enrolled 120 participants in the Philippines. Both trials assessed safety and immunogenicity in healthy volunteers aged 6 weeks and older.

How does Vi-CRM197 vaccine work?

Vi-CRM197 vaccine is a conjugate vaccine that links the Vi capsular polysaccharide of Salmonella Typhi to the non-toxic diphtheria toxin CRM197. This conjugation enhances the immune response, particularly in young children, by converting the T-cell-independent polysaccharide antigen into a T-cell-dependent antigen, leading to stronger and longer-lasting immunity.

Is Vi-CRM197 vaccine the same as other typhoid vaccines?

Vi-CRM197 vaccine is a distinct investigational conjugate vaccine, different from licensed typhoid vaccines such as the Vi polysaccharide vaccine or the live attenuated Ty21a vaccine. Its CRM197 carrier protein is designed to improve immunogenicity in infants and young children, a population where older polysaccharide vaccines are less effective.