Clinical Trials Logo
  1. Home
  2. Dengue Virus
  3. NCT05507450

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

Dengue Virus Clinical Trial

Official title:
A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Three Different Potency Levels of V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [Live, Attenuated]) in Healthy Adults

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05507450
Study type Interventional
Source Merck Sharp & Dohme LLC
Contact
Status Active, not recruiting
Phase Phase 2
Start date September 7, 2022
Completion date May 6, 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT00788151 - Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years Phase 2
Completed NCT00993447 - Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America Phase 2
Active, not recruiting NCT03141138 - Comparison of Tetravalent Dengue Virus Purified Inactivated Vaccine and Tetravalent Dengue Virus Live Attenuated Vaccine Phase 1
Completed NCT02305732 - A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components
Completed NCT00875524 - Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects Phase 2
Completed NCT02794181 - Zika Virus and Related Arbovirus Infections in Deferred Blood Donors (ZVADD)
Completed NCT01073306 - Safety and Immune Response to an Investigational Dengue Type 2 Vaccine Phase 1
Completed NCT00842530 - Efficacy and Safety of Dengue Vaccine in Healthy Children Phase 2
Completed NCT00740155 - Safety and Immunogenicity of Formulations of Dengue Vaccines in Healthy Flavivirus-Naïve Adults Phase 2
Completed NCT00730288 - Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects Phase 2
Completed NCT00880893 - Study of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Subjects in Singapore Phase 2
Completed NCT01084291 - Evaluation of the Safety and Immune Response to an Investigational Dengue Type 1 Vaccine Phase 1
Completed NCT00617344 - Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US Phase 2