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Two doses of JE vaccine

Phase 2

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

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

Two doses of 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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Frequently asked questions about Two doses of JE vaccine

What is Two doses of JE vaccine used for?

Two doses of JE vaccine is a Japanese encephalitis vaccine being studied for use in rabies pre-exposure prophylaxis. The investigational vaccine is being evaluated for immunogenicity, safety, and booster response when administered together with a rabies vaccine in toddlers.

Who makes Two doses of JE vaccine?

Two doses of JE vaccine is being developed by Novartis AG, traded on the New York Stock Exchange under the ticker NVS. The company is conducting clinical research on this investigational Japanese encephalitis vaccine.

What phase is Two doses of JE vaccine in?

Two doses of JE vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 2 trial has been completed.

What clinical trials is Two doses of JE vaccine in?

Two doses of JE vaccine has one completed Phase 2 trial, NCT00694460, which evaluated immunogenicity, safety, and booster response when administered with a rabies vaccine in toddlers. The trial enrolled 200 participants in Thailand and was active-controlled.

Is Two doses of JE vaccine the same as a rabies vaccine?

No, Two doses of JE vaccine is a Japanese encephalitis vaccine, not a rabies vaccine. In the clinical trial NCT00694460, it was administered concomitantly with a rabies vaccine to evaluate their combined use for pre-exposure prophylaxis against both diseases.