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Preliminary Safety Assessment of a Quadrivalent Subunit Influenza Vaccine in China
Sponsor: Ab&B Bio-tech Co., Ltd.JS
Summary
This study evaluates the safety of the quadrivalent subunit influenza vaccine in individuals aged 3 years and older in Jiangsu Province, China. The primary objectives are to assess the occurrence of very rare adverse reactions (incidence \<0.01%), investigate the incidence of cerebral infarction following vaccination, and evaluate the incidence of systemic adverse events among participants aged 9 to 17 years.
Official title: Preliminary Safety Assessment of a Quadrivalent Subunit Influenza Vaccine Following Post-Marketing in China: An Open-Label, Single-Arm Clinical Trial
Key Details
Gender
All
Age Range
3 Years - Any
Study Type
INTERVENTIONAL
Enrollment
3105
Start Date
2024-11-15
Completion Date
2025-05-29
Last Updated
2026-07-20
Healthy Volunteers
Yes
Conditions
Interventions
quadrivalent subunit influenza vaccine
one dose of quadrivalent subunit influenza vaccine
Locations (2)
Dongtai Center for Disease Control and Prevention
Dongtai, Jiangsu, China
Lianshui County Center for Disease Control and Prevention
Lianshui, Jiangsu, China