四价流感病毒裂解疫苗(安徽智飞龙科马生物)(Influenza vaccine (split virion, quadrivalent)(Anhui Zhifei Longcom Biopharmaceutical))

概要

基本信息

药物类型

预防性疫苗、多价疫苗

别名-

靶点-

作用机制

免疫刺激剂

治疗领域

感染呼吸系统疾病

在研适应症

流感病毒感染

非在研适应症-

原研机构

安徽智飞龙科马生物制药有限公司

在研机构

安徽智飞龙科马生物制药有限公司

非在研机构-

最高研发阶段申请上市

首次获批日期-

最高研发阶段(中国)申请上市

特殊审评-

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关联

5

项与四价流感病毒裂解疫苗(安徽智飞龙科马生物) 相关的临床试验

NCT05642078 / Completed临床3期

A Randomized, Blind, Position-controlled Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Quadrivalent Influenza Virus Split Vaccine in 6-35 Months of Age

A randomized, blind, positive vaccine control trial was designed.A total of 2550 subjects aged 6-35 months were randomly assigned to the low dose (0.25ml/ dose) group, the high dose (0.5ml/ dose) group and the control group in a ratio of 1:1:1. They were inoculated with 2 doses of quadrivalent influenza virus split vaccine (experimental vaccine or control vaccine) at 0 and 28 days of immunization program to observe the Immunogenicity and safety.

开始日期2023-02-18

申办/合作机构

安徽智飞龙科马生物制药有限公司