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Tetravalent CYD Dengue Vaccine, 5555 formulation

Phase 2

Dengue Fever | Vaccine | Infectious Disease |Sanofi|Last Updated: Jun 11, 2019

Target and mechanism

ModalityVaccine

Also known as Tetravalent CYD Dengue Vaccine , 5555 formulation

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment260

FDA Designations

No designations recorded

Clinical trial landscape

Tetravalent CYD Dengue Vaccine, 5555 formulation · 1 trial · 3 indications

Phase 2 1
NCT00617344Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the USDengue Fever
COMPLETED260 Analytics
PHASE2COMPLETED
Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US
Dengue FeverUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation
Pre-injection 1 (Day 0), 30 days post-injection 2 (Month 7)

Percentage of participants with antibody titers \>= 10 (1/dil) against each serotypes (1, 2, 3 and 4) of the dengue virus strains was assessed by dengue plaque reduction neutralization test (PRNT).

Secondary Endpoints

Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain
Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13)
Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes
Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13)
Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain
Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
CYD Dengue Vaccine 5555 FormulationEXPERIMENTALParticipants received 3 doses of CYD dengue vaccine (5555 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
CYD Dengue Vaccine 5553 FormulationEXPERIMENTALParticipants received 3 doses of CYD dengue vaccine (5553 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
CYD Dengue Vaccine 4444 FormulationEXPERIMENTALParticipants received 3 doses of CYD dengue vaccine (4444 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.

Interventions

NameTypeDescription
Tetravalent CYD Dengue Vaccine , 5555 formulationBIOLOGICALA 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively.
Tetravalent CYD Dengue Vaccine , 5553 formulationBIOLOGICALA 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively
Tetravalent CYD Dengue Vaccine, 4444 formulationBIOLOGICALA 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites5

Inclusion Criteria: * Healthy, as determined by medical history, clinical examination, and biological safety parameters. * Aged 18 to 45 years on the day of inclusion. * Provision of informed consent signed by the participant or another legally acceptable representative. * For a woman of child-bear...

Countries:United States
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Frequently asked questions about Tetravalent CYD Dengue Vaccine, 5555 formulation

What is Tetravalent CYD Dengue Vaccine, 5555 formulation?

Tetravalent CYD Dengue Vaccine, 5555 formulation is an investigational vaccine developed by Sanofi for the prevention of dengue fever. It is a tetravalent candidate, meaning it is designed to cover four dengue virus serotypes, and it was studied in healthy adults aged 18 to 45 years in the United States.

What is Tetravalent CYD Dengue Vaccine, 5555 formulation used for?

Tetravalent CYD Dengue Vaccine, 5555 formulation is being developed for dengue fever, including dengue hemorrhagic fever and dengue virus infection. It is a preventive vaccine candidate rather than a treatment, and it has been evaluated in healthy adult volunteers in the United States.

Who is developing Tetravalent CYD Dengue Vaccine, 5555 formulation?

Sanofi is the developer of Tetravalent CYD Dengue Vaccine, 5555 formulation. Sanofi trades on the New York Stock Exchange under the ticker SNY. The company sponsored the clinical program for this dengue vaccine candidate.

What phase is Tetravalent CYD Dengue Vaccine, 5555 formulation in?

Tetravalent CYD Dengue Vaccine, 5555 formulation is in Phase 2 development. It is an investigational vaccine candidate and is not approved for use. The Phase 2 study evaluating this formulation has been completed.

What clinical trials is Tetravalent CYD Dengue Vaccine, 5555 formulation in?

Tetravalent CYD Dengue Vaccine, 5555 formulation was studied in one completed Phase 2 trial, NCT00617344, titled Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US. The randomized, double-blind, controlled trial enrolled 260 participants in the United States.

Is Tetravalent CYD Dengue Vaccine, 5555 formulation the same as Tetravalent CYD Dengue Vaccine?

Tetravalent CYD Dengue Vaccine, 5555 formulation is also written as Tetravalent CYD Dengue Vaccine , 5555 formulation. The 5555 designation identifies this specific formulation of the tetravalent CYD dengue vaccine candidate developed by Sanofi, distinguishing it from other formulations tested in the same clinical program.