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Safety and Immunogenicity of Three V181 Dengue Vaccine Potencies in Adults (V181-003)

NCT05507450 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1271

Last updated 2025-05-09

Study results available
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Summary

The primary objective of this study is to compare the dengue virus-neutralizing antibody geometric mean titers (GMTs) for each of the 4 dengue serotypes (DENV1, DENV2, DENV3, and DENV4) at Day 28 post-vaccination for participants administered the V181 Low-Potency Level vaccine versus the V181 Mid-Potency Level vaccine. This study will also evaluate the safety and tolerability of 3 different V181 potency level vaccines. The primary hypothesis of the study is that the V181 Low-Potency Level vaccine is non-inferior to the V181 Mid-Potency Level vaccine for each of the 4 dengue serotypes based on GMTs at Day 28 post-vaccination.

Conditions

  • Dengue Disease
  • Dengue Virus

Interventions

BIOLOGICAL

V181 High-Potency Level

0.5 mL SC dose of V181 High-Potency vaccine

BIOLOGICAL

V181 Mid-Potency Level

0.5 mL SC dose of V181 Mid-Potency vaccine

BIOLOGICAL

V181 Low-Potency Level

0.5 mL SC dose of V181 Low-Potency vaccine

BIOLOGICAL

Placebo

0.5 mL SC dose of placebo

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-09-07
Primary Completion
2023-06-05
Completion
2024-05-07
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Finland
  • Germany
  • Israel
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
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 NCT05507450 on ClinicalTrials.gov