A Phase I Clinical Trial for Inactivated Quadrivalent Influenza Vaccine (Split Virion) in Healthy Adults in China
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      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.

      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.
    

Detailed 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.
    

Intervention name(s): inactivated quadrivalent influenza vaccine (split virion)
Intervention type(s): Biological
Intervention description(s): 0.5ml inactivated quadrivalent influenza vaccine (split virion) for each subject, one dose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: safety, tolerance, quadrivalent influenza vaccine