Clinical Trial of the Safety and Immunogenicity of a Tetravalent Dengue Virus Vaccine Admixture TV005 in the Elderly Aged 50-70 Years in Taiwan

Dengue Clinical Trial

Official title: Phase II, Randomized, Double-blind, Clinical Tial of the Safety and Immunogenicity of a Tetravalent Dengue Virus Vaccine Admixture TV005 in the Elderly Aged 50-70 Years in Taiwan

Status Completed

Clinical Trial Summary

Phase II, randomized, double-blind, placebo-controlled study of the safety and immunogenicity of the recombinant live attenuated tetravalent dengue virus vaccine admixture TV005 in the elderly in Taiwan

Clinical Trial Description

In Taiwan, people who aged 50 to 70 years accounted for over 40% among those who infected by dengue virus every year. Therefore, to understanding the immunogenicity and safety of TV005 vaccine among people aged 50 to 70 years is important for whether TV005 can be introduced into Taiwan as a major intervention to control dengue. This trial is a phase II, double-blind, multicenter, and placebo-controlled one. The investigators plan to enroll 252 subjects whose age are 50 to 70 years at four study sites. One single-dose TV005 vaccine or placebo will be given subcutaneously. After vaccination, detailed data of the subjective symptoms, physical examination, laboratory examination, and titer of neutralization antibody from all subjects will be recorded. After completion of the present trial, the investigators can clarify the immunogenicity and safety of TV005 among people aged 50 to 70 years. ;

Related Conditions & MeSH terms

• Dengue

• NCT number: NCT04133987
• Study type: Interventional
• Source: National Taiwan University Hospital
• Status: Completed
• Phase: Phase 2
• Start date: October 15, 2018
• Completion date: September 30, 2022