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Vi-CRM197 vaccine

Phase 2

Typhoid Fever | Monoclonal antibody | Other |Novartis AG|Last Updated: May 1, 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
RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment320
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01437267Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and InfantsPHASE2 COMPLETED 120 — — Oct 1, 2011Aug 1, 2012Apr 10, 20141 Philippines
NCT01229176Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and InfantsPHASE2 COMPLETED 200 — — Mar 1, 2011Jun 1, 2012May 1, 20142 India, Pakistan
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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 — 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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