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Tetravalent CYD Dengue Vaccine , 5555 formulation

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment260
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00617344Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the USPHASE2 COMPLETED 260 — — Apr 17, 2008Feb 1, 2010Jun 11, 20195 United States
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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 — 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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