Butantan-DV Vaccine in Elderly Populations (DEN-04-IB)
ConditionDengue
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-79
SponsorButantan Institute
About this trial
This is a randomized, double-blind (60 -79 years) and open-label (40-59 years), three-arm parallel Phase 3b, multicenter study to evaluate the safety and non-inferiority of the humoral immune response of the Butantan Dengue vaccine (Dengue 1,2,3,4 (attenuated)) in participants aged 60 -79 years (elderly) compared to participants aged 40 to 59 years (adults), with or without previous dengue and healthy based on clinical examination.
Eligibility criteria
Qualifiers
a. Healthy participants aged between 40 and 79 years at the time of study entry, with or without a history of exposure to dengue fever;
Disqualifiers
a. For female participants with reproductive potential: pregnancy (confirmed by positive β-hCG test), breastfeeding or manifest intention to have sexual practices with reproductive potential without using a contraceptive method in the 90 days following vaccination;
Trial design
Treatments tested in this trial
- Dengue 1,2,3,4 (attenuated) vaccine
Treatment groups
997 Participants
are divided into 3 treatment groupsLocations
5CWB 02 - Centro Médico São Francisco80810-050, CuritibaParaná, Brazil
PET 01 - Hospital Escola da Universidade de Pelotas - HEUFPEL96040-010, PelotasRio Grande do Sul, Brazil
POA 01 - Centro de Pesquisa: Hospital São Lucas - PUCRS90610-000, Porto AlegreRio Grande do Sul, Brazil
POA 02 - Associação Hospitalar Moinhos de Vento90560-032, Porto AlegreRio Grande do Sul, Brazil
Sponsors and collaborators
Butantan Institute
Lead sponsor
Butantan Foundation
Collaborator
Source ClinicalTrials.gov