Butantan Institute
The purpose of this study is to demonstrate that V181 is safe and well tolerated and elicits an immune response that is non-inferior to that of Butantan-DV at Day 28 post-vaccination in adults 18 to 50 years of age in Brazil. The primary hypothesis is that V181 is non-inferior to Butantan-DV for each of the 4 dengue serotypes based on geometric mean titers (GMTs) and seroconversion rates at Day 28 post-vaccination.
Dengue
Q181
Butantan-DV
Phase 2
Study Type : | Interventional |
Estimated Enrollment : | 1364 participants |
Masking : | Triple |
Primary Purpose : | Prevention |
Official Title : | A Phase 2, Randomized, Double-Blind, Multicenter, Safety and Immunogenicity Clinical Bridging Study to Compare V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [Live, Attenuated]) to Butantan Dengue Vaccine (Butantan-DV) in Healthy Adults 18 to 50 Years of Age in Brazil |
Actual Study Start Date : | February 15, 2023 |
Estimated Primary Completion Date : | January 22, 2024 |
Estimated Study Completion Date : | November 29, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Q181 Participants will receive a single 0.5 mL subcutaneous (SC) injection of V181 on Day 1. |
Biological: V181 |
Experimental: Butantan-DV Participants will receive a single 0.5 mL SC injection of Butantan-DV on Day 1. |
Biological: Butantan-DV |
Ages Eligible for Study: | 18 Years to 50 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Hospital Tacchini (Site 0006)
Bento Gonçalves, Rio Grande do Sul, Brazil, 95700084
Not yet recruiting
University of Caxias do Sul Foundation (FUCS) - Health Research Institute (IPS) (Site 0017)
Caxias do Sul, Rio Grande do Sul, Brazil, 95070560
Not yet recruiting
ONCOSITE - Center for Clinical Research in Oncology (Site 0005)
Ijuí, Rio Grande do Sul, Brazil, 98700-000
Not yet recruiting
Hospital São Vicente de Paulo-Education and Research Management (Site 0007)
Deep step, Rio Grande do Sul, Brazil, 99010-080
Not yet recruiting
Méderi Institute for Research and Health (0020)
Deep step, Rio Grande do Sul, Brazil, 99010-120
Not yet recruiting
Teaching Hospital of the Federal University of Pelotas (Site 0009)
Pellets, Rio Grande do Sul, Brazil, 96020-360
Not yet recruiting
Brotherhood of the Santa Casa de Misericórdia of Porto Alegre-Center for Research in Infectious Diseases (Site # 003)
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
Not yet recruiting
Clinical Research Center of Rio Grande do Sul (Site 0011)
Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
Not yet recruiting
LMK Serviços Médicos S/S-Reumacenter (Site 0004)
Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
Not yet recruiting
Hospital Moinhos de Vento - Clinical Research Center (Site0021)
Porto Alegre, Rio Grande do Sul, Brazil, 90560-030
Not yet recruiting
São Lucas Hospital of PUCRS-HSL-PUCRS Clinical Research Center (Site 0015)
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Not yet recruiting
Federal University of Santa Maria (UFSM) - Univer Hospital-Clinical Research Unit-UPC (Site 0001)
Santa Maria, Rio Grande do Sul, Brazil, 97105-900
Not yet recruiting
Supera Clinic (Site 0019)
Chapecó, St. Catarina, Brazil, 89812-211
Not yet recruiting
Criciuma (Site 0008)
Deep step, St. Catarina, Brazil, 88811508