The purpose of this study was 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 was 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,364
0.5 mL SC dose of V181
0.5 mL SC dose of Butantan - DV
Hospital Tacchini (Site 0006)
Bento Gonçalves, Rio Grande do Sul, Brazil
Fundação Universidade de Caxias do Sul (FUCS) - Instituto de Pesquisas em Saúde (IPS) (Site 0017)
Caxias do Sul, Rio Grande do Sul, Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia (Site 0005)
Ijuí, Rio Grande do Sul, Brazil
Hospital São Vicente de Paulo-Education and Research Management (Site 0007)
Passo Fundo, Rio Grande do Sul, Brazil
Instituto Méderi de Pesquisa e Saúde (0020)
Passo Fundo, Rio Grande do Sul, Brazil
Hospital Escola da Universidade Federal de Pelotas (Site 0009)
Pelotas, Rio Grande do Sul, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro de Pesquisa em Infectologia (Site # 003)
Porto Alegre, Rio Grande do Sul, Brazil
Núcleo de Pesquisa Clínica do Rio Grande do Sul (Site 0011)
Porto Alegre, Rio Grande do Sul, Brazil
LMK Serviços Médicos S/S-Reumacenter (Site 0004)
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Moinhos de Vento - Centro de Pesquisa Clínica (Site0021)
Porto Alegre, Rio Grande do Sul, Brazil
...and 4 more locations
Dengue Virus (DENV)-Neutralizing Antibody Titers as Measured by Virus Reduction Neutralization Test (VRNT)
A dengue VRNT was conducted to assess neutralizing antibody geometric mean titers (GMTs) for each of the 4 dengue serotypes (DENV1, DENV2, DENV3, and DENV4) in specimens collected from participants on Day 28 post-vaccination
Time frame: Day 28 post-vaccination
Percentage of Participants Who Seroconverted, as Measured by VRNT
A dengue VRNT was conducted to assess the percentage of participants who seroconverted for each of the 4 dengue serotypes (DENV-1, DENV-2, DENV-3 and DENV-4) at Day 28 post-vaccination. Seroconversion was defined as achieving a serotype-specific VRNT titer ≥lower limit of quantification (LLOQ) at Day 28 post-vaccination in the analysis population.
Time frame: Day 28 post-vaccination
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)
An SAE is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator.
Time frame: Up to 28 days post-vaccination
Percentage of Participants Who Experience Solicited Injection-site Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included erythema (redness), pain, and swelling.
Time frame: Up to 5 days post-vaccination
Percentage of Participants Who Experience Solicited Systemic AEs
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs include arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), pyrexia (axillary temperature ≥37.8°C or 100°F), and rash.
Time frame: Up to 28 days post-vaccination
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