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TV003 Dengue Vaccine in Healthy Thai Population
NCT02332733Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2014
- Primary completion
- Oct 2018
- Countries
- 1
- Sponsor
- National Institute of Allergy and Infectious Diseases
- Modality
- Live Attenuated Vaccines
- Drugs
- TetraVax-DV
- Conditions
- dengue fever
01
Overview
Phase 2, randomised, double-blind trial in dengue fever comparing TV003 Vaccine with Placebo (2 arms). Primary endpoints: Occurrence of solicited local and general adverse events, Occurrence of unsolicited adverse events and 2 more. Started Nov 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
TV003 Vaccine
TV003 administered at Day 0 and Day 180
Placebo
Placebo administered at Day 0 and Day 180
03
Who it enrols
Healthy participants aged 12 months to 50 years residing in the greater Bangkok area, without significant chronic diseases, immunodeficiency, or pregnancy.
04
Endpoints
Primary
Occurrence of solicited local and general adverse events
Occurrence of unsolicited adverse events
Occurrence of serious adverse events
Serum plaque reduction neutralization titer 50%
Secondary
Frequency of viremia of each monovalent component
Quantity of viremia of each monovalent component
Number of vaccinees infected with DENV-1, DENV-2, DENV-3, and DENV-4
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