Trial Profile
Phase III, Double-Blind, Randomized, Placebo-Controlled Trial to Investigate the Efficacy, Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TDV) Administered Subcutaneously in Healthy Children Aged 4 - 16 Years Old
Status:
Active, no longer recruiting
Phase of Trial:
Phase III
Latest Information Update: 09 Feb 2024
Price :
$35
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At a glance
- Drugs TAK 003 (Primary)
- Indications Dengue
- Focus Registrational; Therapeutic Use
- Acronyms TIDES
- Sponsors Takeda
- 03 Oct 2023 According to a Takeda media release, based on results from this trial, the World Health Organization's (WHO) Strategic Advisory Group of Experts (SAGE) on Immunization shared recommendations for use of QDENGA.
- 10 Aug 2023 Planned End Date changed from 21 Mar 2024 to 12 Aug 2024.
- 13 Mar 2023 According to a Takeda media release, company announced the QDENGA (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003), was approved in Brazil by the National Health Surveillance Agency (ANVISA) for the prevention of dengue caused by any of the four virus serotypes that can be found in individuals from 4 to 60 years of age.