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Tetravalent blending VDV-2/CYD-1, 3, 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

Tetravalent blending VDV-2/CYD-1, 3, 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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Frequently asked questions about Tetravalent blending VDV-2/CYD-1, 3, 4 Dengue

What is Tetravalent blending VDV-2/CYD-1,3,4 Dengue used for?

Tetravalent blending VDV-2/CYD-1,3,4 Dengue is an investigational monoclonal antibody being developed for the prevention of Dengue Virus infections, including Dengue Fever and Dengue Hemorrhagic Fever. It is a tetravalent vaccine formulation designed to target all four dengue virus serotypes. The drug is currently in Phase 2 clinical development.

Who makes Tetravalent blending VDV-2/CYD-1,3,4 Dengue?

Tetravalent blending VDV-2/CYD-1,3,4 Dengue is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the safety and immunogenicity of this dengue vaccine candidate.

What phase is Tetravalent blending VDV-2/CYD-1,3,4 Dengue in?

Tetravalent blending VDV-2/CYD-1,3,4 Dengue is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for its safety and immunogenicity in healthy adults, with one completed Phase 2 trial involving 154 participants.

What clinical trials is Tetravalent blending VDV-2/CYD-1,3,4 Dengue in?

Tetravalent blending VDV-2/CYD-1,3,4 Dengue has been studied in one clinical trial, identified as NCT00740155. This Phase 2 trial, titled 'Safety and Immunogenicity of Formulations of Dengue Vaccines in Healthy Flavivirus-Naïve Adults,' was completed and enrolled 154 participants in Mexico. The trial was randomized and active-controlled, evaluating the vaccine in healthy volunteers aged 18 years and older.

How does Tetravalent blending VDV-2/CYD-1,3,4 Dengue work?

Tetravalent blending VDV-2/CYD-1,3,4 Dengue is a tetravalent vaccine formulation that combines the VDV-2 component with CYD-1, CYD-3, and CYD-4 components. It is designed to elicit an immune response against all four dengue virus serotypes, potentially providing broad protection against dengue disease. The vaccine is administered to stimulate the production of neutralizing antibodies.