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Bivalent CYD-1, 3 Dengue+ Bivalent CYD-2, 4 Dengue

Phase 2

Dengue Virus | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Mar 3, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment154

FDA Designations

No designations recorded

Clinical trial landscape

Bivalent CYD-1, 3 Dengue+ Bivalent CYD-2, 4 Dengue · 1 trial · 4 indications

Phase 2 1
NCT00740155Safety and Immunogenicity of Formulations of Dengue Vaccines in Healthy Flavivirus-Naïve AdultsDengue Virus
COMPLETED154 Analytics
PHASE2COMPLETED
Safety and Immunogenicity of Formulations of Dengue Vaccines in Healthy Flavivirus-Naïve Adults
Dengue VirusUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety: To provide information concerning the safety of ChimeriVax™ Dengue Vaccine
12 months post-vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTAL -
Group 2EXPERIMENTAL -
Group 3EXPERIMENTAL -
Group 4EXPERIMENTAL -
Group 5ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero)BIOLOGICAL0.5 mL, Subcutaneous (SC) (CYD-1,3 Day 0; CYD-2,4 Day 105)
Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero)BIOLOGICAL0.5 mL, Subcutaneous (SC) (Day 0 and Day 105)
Tetravalent CYD-1,2,3,4 Dengue (Vero)BIOLOGICAL0.5 mL, Subcutaneous (SC) (Day 0 and Day 105)
JE-VAX®: Japanese encephalitis virus vaccine inactivated + Tetravalent CYD-1,2,3,4 Dengue (Vero)BIOLOGICAL0.5 mL, Subcutaneous (SC) (JE-VAX® Day 0 + Tetravalent CYD-1,2,3,4 on Day 105)
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria : * Healthy as determined by medical history, clinical examination, and biological safety parameters * Aged 18 to 45 years on the day of inclusion. * Informed consent form signed. * Able to attend all scheduled visits and to comply with all trial procedures * For a woman of child...

Countries:Mexico
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