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Live, attenuated, dengue serotype 1, 2, 3, 4 virus

Phase 3

Dengue | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Mar 21, 2022

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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment10,275
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01373281Study of a Novel Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 14 Years in AsiaPHASE3 COMPLETED 10,275 — — Jun 3, 2011Nov 21, 2017Mar 21, 202212 Indonesia, Malaysia +3
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Study Endpoints
Primary Endpoints
Number of Symptomatic Virologically Confirmed Dengue (VCD) Cases Due to Any Serotype During the Active Phase Post-dose 3 Following Injection (Inj.) With Either CYD Dengue Vaccine or a Placebo
28 days and up to 13 months post-dose 3

Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature \>=38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue reverse transcriptase polymerase chain reaction and/or dengue NS protein 1 antigen enzyme-linked immunosorbent assay. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Vaccine Group.

Secondary Endpoints
Geometric Mean Titers of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Pre-injection 1, 28 days post Injections 2 and 3, 13 months (Visit 07) and 60 months (Visit 12) post-injection 3
Percentage of Participants With Antibody Titers >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain Before and Following Inj. With CYD Dengue Vaccine or Placebo
Pre-injection 1, 28 days post Injections 2 and 3, 13 months (V 07) and 60 months (V 12) post-injection 3
Number of Symptomatic VCD Cases Due to Any Serotype Occurring 28 Days Post-dose 1 Following Injection With Either CYD Dengue Vaccine or a Placebo
28 days post-injection 1 and up to 13 months post-injection 3
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Dengue Vaccine GroupEXPERIMENTALParticipants were to receive CYD dengue vaccine at 0, 6, and 12 months.
Control GroupPLACEBO_COMPARATORParticipants were to receive a placebo vaccine at 0, 6, and 12 months.
Interventions
NameTypeDescription
Live, attenuated, dengue serotype 1, 2, 3, 4 virusBIOLOGICAL0.5 mL, Subcutaneous
Placebo: Sodium chloride (NaCl) 0.9%BIOLOGICAL0.5 mL, Subcutaneous
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Eligibility Criteria
Age Range2 Years — 14 Years
SexALL
Healthy VolunteersYes
Study Sites12

Inclusion Criteria: * Aged 2 to 14 years on the day of inclusion and resident of the site zone * Participant was in good health, based on medical history and physical examination * Assent form or informed consent form has been signed and dated by the participant (based on local regulations), and in...

Countries:IndonesiaMalaysiaPhilippinesThailandVietnam
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Competitive Landscape -Dengue 10 trials
CompanyTickerTrialsLead PhaseDrugs
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3Tetravalent Dengue Vaccine, TDV
Novartis AG Sponsored ADRNVS1PHASE2EYU688
Sanofi SA Sponsored ADRSNY1 — Undisclosed
Abbott LaboratoriesABT1 — Undisclosed
Danaher CorporationDHR1 — Undisclosed
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