Influenza Clinical Trial
Official title:
A Double-blind,Randomized,Positive-controlled, Non-inferiority Phase III Clinical Trial of An Inactivated Quadrivalent Influenza Vaccine (Split Virion) in Healthy Chinese Subjects Aged 3 Years and Older
Influenza is an acute respiratory disease caused by influenza viruses. There are three types
of the virus including A, B and C. Both type A and type B viruses can cause acute febrile
respiratory tract infection, characterized by sudden fever, headache, muscle pain, cough,
sore throat, nasal congestion and general malaise. The main transmission of influenza is
through those highly contagious aerosol droplets containing influenza virus passed from
infected people to susceptible population. Each year in the fall and winter infection of
influenza is widespread in various age groups, with high incidence rate. Although influenza
is generally a self-limiting disease, but in children, the elderly (especially those above
65 years old and those with chronic heart, lung, kidney, liver, blood or metabolic diseases
such as diabetes or other certain diseases) and those with poor immunity function, influenza
can easily lead to serious flu complications such as pneumonia, resulting in severe increase
of morbidity and mortality.
In order to evaluate safety and immunogenicity of a quadrivalent influenza vaccine produced
by Jiangsu Jindike Biotechnology Co., Ltd. a phase III clinical trial is planned to conduct
in healthy Chinese subjects aged 3 years and older.
Subjects will be randomized into three arms- Experimental Group, Active Comparator A and Active Comparator B by the ratio of 2:1:1. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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