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Two doses of JE vaccine

Phase 2

Rabies | Monoclonal antibody | Other |Novartis AG|Last Updated: Jun 10, 2008

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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00694460Evalution of Immunogenicity, Safety and Booster Response of a Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine in ToddlersPHASE2 COMPLETED 200Aug 1, 2002Sep 1, 2004Jun 10, 20081 Thailand
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Study Endpoints
Primary Endpoints
Rabies virus neutralizing antibody concentrations
2 years
Secondary Endpoints
Japanese encephalitis virus neutralizing antibody titers
2 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4EXPERIMENTAL -
5ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Three 1 mL doses of Rabies vaccine and two JE vaccineBIOLOGICALVaccination with purified chick embryo cell rabies vaccine 1.0 mL intramuscularly on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)
Three 0.5 mL doses of Rabies vaccine and two JE vaccineBIOLOGICALVaccination with purified chick embryo cell rabies vaccine 0.5 mL intramuscularly on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)
Three 0.1mL doses of Rabies Vaccine and two JE vaccineBIOLOGICALVaccination with purified chick embryo cell rabies vaccine 0.1 mL intradermally at one site on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)
Two 0.1mL doses of Rabies vaccine and two JE vaccineBIOLOGICALVaccination with purified chick embryo cell rabies vaccine 0.1 mL intradermally at one site on Day 0 and Day 28 (a total of 2 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)
Two doses of JE vaccineBIOLOGICALVaccination with Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL only subcutaneously on Day 0 and Day 7 (a total of 2 doses)
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Eligibility Criteria
Age Range12 Months — 18 Months
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male and female 12-18 months old toddlers if they * are in good health at time of entry into the study * are available for all the visits scheduled in the study * have been granted a written informed consent, signed by their parents Exclusion Criteria: * a history of rabies ...

Countries:Thailand
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