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Japanese encephalitis chimeric virus vaccine

Phase 3

Encephalitis | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Dec 25, 2013

Target and mechanism

ModalityMonoclonal antibody

Also known as Japanese encephalitis chimeric virus vaccine (JE-CV)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment300

FDA Designations

No designations recorded

Clinical trial landscape

Japanese encephalitis chimeric virus vaccine · 1 trial · 2 indications

Phase 3 1
NCT01092507A Study of Japanese Encephalitis Chimeric Virus Vaccine Compared With SA14-14-2 Vaccine in Infants and ToddlersEncephalitis
COMPLETED300 Analytics
PHASE3COMPLETED
A Study of Japanese Encephalitis Chimeric Virus Vaccine Compared With SA14-14-2 Vaccine in Infants and Toddlers
EncephalitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Japanese Encephalitis Seroconversion After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®)
Day 0 through Day 28 after vaccination

Immunogenicity was assessed by the JE-CV virus and the SA14-14-2 virus 50% plaque reduction neutralization test (PRNT50). Japanese Encephalitis seroconversion was defined as a pre-vaccination titer \<10 1/dil and post-vaccination titer ≥ 10 1/dil; or a pre-vaccination titer ≥ 10 1/dil and a 4-fold increase from pre- to post-vaccination.

Secondary Endpoints

Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®)
Day 28 post-vaccination
Number of Participants With Seroconversion After Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®)
Day 28 post-vaccination
Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®)
Day 0 (pre-vaccination) and Day 28 post-vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
JE-CV GroupEXPERIMENTALParticipants will receive one dose of Japanese encephalitis chimeric virus vaccine (JE-CV)
SA14-14-2 vaccine GroupACTIVE_COMPARATORParticipants will receive one dose of Japanese encephalitis live vaccine, SA14-14-2 vaccine. (CD.JEVAX®)

Interventions

NameTypeDescription
Japanese encephalitis chimeric virus vaccine (JE-CV)BIOLOGICAL0.5 mL, Subcutaneous
Japanese encephalitis live vaccine (SA14-14-2 vaccine) (CD.JEVAX®)BIOLOGICAL0.5 mL, Subcutaneous
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Eligibility Criteria

Age Range9 Months to 18 Months
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria : * Aged 9 to 18 months on the day of inclusion * In good general health, without significant medical history * Provision of informed consent form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by loca...

Countries:Thailand
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