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Safety and Immunogenicity of Dengue Tetravalent Vaccine (TDV) in Children 6 to <21 Months
NCT06665035Phase 3
Key facts
- Status
- Recruiting
- Start
- Jun 2025
- Primary completion
- Mar 2030
- Countries
- 2
- Sponsor
- Takeda
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- dengue fever
01
Overview
Phase 3, randomised, double-blind trial of dengue tetravalent vaccine (live, attenuated) in dengue fever (4 cohorts), sponsored by Takeda. Primary endpoints: Percentage of Participants with Solicited Local (Injection Site) Adverse Events, Percentage of Participants with Solicited Systemic Adverse Events and 4 more. Started Jun 2025; status: recruiting.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Cohort 1: TDV (>=12 to <21 months)
Participants aged >=12 to <21 months receiving TDV 0.5 mL SC on Day 1 and Day 90
Cohort 1: Placebo (>=12 to <21 months)
Participants aged >=12 to <21 months receiving Placebo SC on Day 1 and Day 90
Cohort 2: TDV (>=6 to <12 months)
Participants aged >=6 to <12 months receiving TDV 0.5 mL SC on Day 1 and Day 90
Cohort 2: Placebo (>=6 to <12 months)
Participants aged >=6 to <12 months receiving Placebo SC on Day 1 and Day 90
03
Who it enrols
Healthy children aged 6 to <21 months without prior dengue vaccination, significant medical conditions, or recent use of immunosuppressive therapies, blood products, or other vaccines.
04
Endpoints
Primary
Percentage of Participants with Solicited Local (Injection Site) Adverse Events
Percentage of Participants with Solicited Systemic Adverse Events
Percentage of Participants with Unsolicited Adverse Events
Percentage of Participants with Medically-attended Adverse Events
Percentage of Participants with Serious Adverse Events
Secondary
Geometric Mean Titers of Neutralizing Antibodies by Microneutralization Test for Each of 4 Dengue Virus Serotypes
Seropositivity Rates for 4 Dengue Virus Serotypes
Seropositivity Rates For Multiple (2, 3, or 4) Dengue Virus Serotypes
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