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Clinical Bridging Study Between V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [Live, Attenuated]) to Butantan Dengue Vaccine (Butantan - DV) in Healthy Adults 18 to 50 Years of Age in Brazil (V181 - 002)

NCT05710224 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1364

Last updated 2025-11-18

Study results available
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Summary

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.

Conditions

  • Dengue

Interventions

BIOLOGICAL

V181

0.5 mL SC dose of V181

BIOLOGICAL

Butantan - DV

0.5 mL SC dose of Butantan - DV

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-15
Primary Completion
2024-01-22
Completion
2024-12-12
FDA Drug
Yes

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05710224 on ClinicalTrials.gov