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Chimeric dengue serotype

Phase 2

Dengue | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Feb 27, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment35

FDA Designations

No designations recorded

Clinical trial landscape

Chimeric dengue serotype · 1 trial · 4 indications

Phase 2 1
NCT00730288Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult SubjectsDengue
COMPLETED35 Analytics
PHASE2COMPLETED
Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects
DengueUnlock trial analytics

Study Endpoints

Primary Endpoints

Immunogenicity: To provide information concerning the immunogenicity of ChimeriVax™
28, 60 and 180 days post vaccination
Safety: To provide information concerning the safety of ChimeriVax™
28 days post-vaccination and entire study duration
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTALReceived monovalent Vero dengue vaccine in Study DIV12
2EXPERIMENTALReceived Yellow fever vaccine in Study DIV12
3EXPERIMENTALFlavivirus-naive subjects

Interventions

NameTypeDescription
Chimeric dengue serotype (1, 2, 3, 4)BIOLOGICAL0.5 mL, Subcutaneous, 1 dose
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria : * Aged 18 to 40 years on the day of inclusion. * Informed consent form signed. * For a woman, inability to bear a child or negative serum pregnancy test. * Completed the one-year follow-up of Study DIV12. * Able to attend all scheduled visits and to comply with all trial proced...

Countries:Australia
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Frequently asked questions about Chimeric dengue serotype

What is Chimeric dengue serotype used for?

Chimeric dengue serotype is an investigational monoclonal antibody being developed for dengue, including dengue fever, dengue hemorrhagic fever, and dengue virus infection. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes Chimeric dengue serotype?

Chimeric dengue serotype is being developed by Sanofi, a biopharmaceutical company traded on the stock exchange under the ticker SNY. The drug is in Phase 2 clinical development for dengue and related conditions.

What phase is Chimeric dengue serotype in?

Chimeric dengue serotype is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved for commercial use. A Phase 2 clinical trial has been completed to evaluate its safety and immunogenicity in adult subjects.

What clinical trials is Chimeric dengue serotype in?

Chimeric dengue serotype has one completed Phase 2 clinical trial, identified as NCT00730288, titled 'Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects.' This trial enrolled 35 participants in Australia and included healthy volunteers aged 18 years and older.

Is Chimeric dengue serotype the same as ChimeriVax™ Dengue Tetravalent Vaccine?

Yes, Chimeric dengue serotype is the same as ChimeriVax™ Dengue Tetravalent Vaccine. The Phase 2 clinical trial NCT00730288, which evaluated the drug, used this alternative name in its title. Both names refer to the same investigational dengue vaccine candidate.