Phase III, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Immunogenicity of the Dengue 1, 2, 3, 4 (Attenuated) Vaccine From Instituto Butantan
Latest Information Update: 18 Nov 2024
At a glance
- Drugs TV 003 (Primary)
- Indications Dengue
- Focus Adverse reactions; Registrational; Therapeutic Use
Most Recent Events
- 01 Nov 2024 Results (n=16235; between Feb 22, 2016, and July 5, 2019; At the data cutoff July 13, 2021) assessing the safety and efficacy through an extended follow-up period, with an average of 3.7 years of follow-up of the live, attenuated, tetravalent Butantan-dengue vaccine (Butantan-DV) in adults, adolescents, and children, published in The Lancet Infectious Diseases.
- 16 Jan 2023 Planned number of patients changed from 16944 to 16935.
- 16 Jan 2023 Status changed from completed to active, no longer recruiting.