Safety and Immunogenicity of V114 in Healthy Infants in South Korea (V114-036)

Summary

The primary purpose of this phase 3, single-arm, open-label study is to evaluate the safety and immunogenicity of a 4-dose regimen of V114 administered to healthy infants in South Korea.

Timeline

Start

2021-02-10

Primary completion

2022-11-04

Completion

2022-11-04

Publications

• Results Maestri A, Park SE, Fernandes F, Li ZL, Kim YJ, Kim YK, Lee J, Park JY, Kim DH, Yang G, Lim H, Kim JO, Lupinacci R, Sterling TM, Wilck M, Esteves-Jaramillo A, Banniettis N. A phase 3, single-arm, open-label study to evaluate the safety, tolerability, and immunogenicity of a 15-valent pneumococcal conjugate vaccine, V114, in a 3+1 regimen in healthy infants in South Korea (PNEU-PED-KOR). Hum Vaccin Immunother. 2024 Dec 31;20(1):2321035. doi: 10.1080/21645515.2024.2321035. Epub 2024 Mar 18.

Drugs

Indications