A Phase I Clinical Trial for Inactivated Quadrivalent Influenza Vaccine

Status Completed

Clinical Trial Summary

Clinical Trial Description

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.

Influenza can periodically cause worldwide pandemic. For nearly a century, the influenza virus had occurred four large variation, causing three world pandemic. Studies have shown that since 1957, most of those new variants of influenza virus started in China, which is recognized by the world to have high incidence of influenza. At present, trivalent influenza vaccines are widely used in China. They only contain two kinds of type A virus antigens and one type B virus antigen. But since 2000, two kinds of type B strains (Victoria and Yamagata) have caused an alternating cycle in different seasons. Gradually, evolved from the original single lineage of influenza B virus B/Yamagata, two distinct antigenic lineages-B/Victoria and B/Yamagata have alternately dominated or caused a mix of popular lineage. These two lineages have little or nearly no cross-protection. Therefore, trivalent influenza vaccines may not cover the popular strains of influenza B virus, whereas quadrivalent influenza vaccines will help to simultaneously prevent two kinds of type A viruses and two kinds of type B virus.

In order to evaluate safety and tolerance of the quadrivalent influenza vaccine produced by Jiangsu Jindike Biotechnology Co., Ltd. a phase I clinical trial is planned to conduct in healthy adults aged from 18 to 49 years in China. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02269007
Study type	Interventional
Source	Jiangsu Province Centers for Disease Control and Prevention
Contact
Status	Completed
Phase	Phase 1
Start date	May 2015
Completion date	September 2015

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A Phase I Clinical Trial for Inactivated Quadrivalent Influenza Vaccine (Split Virion) in Healthy Adults in China

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms