Non-inferiority and Safety Study of EuTCV Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants

Summary

This is an observer-blinded, comparative, single dose, clinical phase II/III study to assess the immunogenicity and safety of EuTCV compared to Typhoid conjugate vaccine in healthy Filipino participants aged 6 months to 45 years.

Timeline

Start

2020-09-07

Primary completion

2021-03-18

Completion

2021-08-01

Publications

• Ok Baik Y, Lee Y, Lee C, Kyung Kim S, Park J, Sun M, Jung D, Young Jang J, Jun Yong T, Woo Park J, Jeong S, Lim S, Hyun Han S, Keun Choi S. A Phase II/III, Multicenter, Observer-blinded, Randomized, Non-inferiority and Safety, study of typhoid conjugate vaccine (EuTCV) compared to Typbar-TCV(R) in healthy 6 Months-45 years aged participants. Vaccine. 2023 Mar 3;41(10):1753-1759. doi: 10.1016/j.vaccine.2022.12.007. Epub 2023 Feb 9.

Drugs

Indications