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Three doses of Rabies vaccine and two JE vaccine

Phase 2

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

Target and mechanism

ModalityMonoclonal antibody

Also known as Three 1 mL doses of Rabies vaccine and two JE vaccine

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

Three doses of Rabies vaccine and two JE vaccine · 1 trial · 3 indications

Phase 2 1
NCT00694460Evalution of Immunogenicity, Safety and Booster Response of a Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine in ToddlersRabies
COMPLETED200 Analytics
PHASE2COMPLETED
Evalution of Immunogenicity, Safety and Booster Response of a Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine in Toddlers
RabiesUnlock trial analytics

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 to 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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