KD-414 Pediatric Phase II/III study (COVID-19) - kd414-04

Fushimi Hideki0 个研究点目标入组 600 人开始时间: 2022年4月22日最近更新: 2023年10月17日

试验速览

暂无简介。

•(1) Healthy Japanese pediatric subjects aged 6 months to < 18 years at the informed consent (regardless of sex). Pediatric subjects with underlying diseases that are in a stable state will be included.
•(2) Subjects who have given written informed consent from their legally acceptable representatives

•(1) Subjects who are infected with novel coronavirus (hereinafter, SARS-CoV-2) or have a history of infection (based on the interview with subjects legally acceptable representatives)
•(2) Subjects who have had close contact with a person infected with SARS-CoV-2 (excluding those whose infection was denied by a test) (based on the interview with subjects legally acceptable representatives)
•(3) Subjects who have received a COVID-19 vaccine (including unapproved vaccines) in the past
•(4) Subjects with a known history of anaphylaxis due to KD-414 or its ingredient (thimerosal).
•(5) Female subjects who are pregnant, may be pregnant, are desiring to become pregnant before completion of the follow-up test, or are breast-feeding.

发起方

Fushimi Hideki