A Clinical Trial for Inactivated Japanese Encephalitis Vaccine in Healthy Chinese Infants
Condition: Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Japanese encephalitis (JE) is an acute viral zoonotic disease. Neurologic manifestations of
      the disease range from subtle changes in behavior to serious problems, including blindness,
      ataxia, weakness, and movement disorders. The Japanese encephalitis virus (JEV) occurs
      primarily in Southeast Asian. It is spread by culicine mosquitoes, most often Culex
      tritaeniorhynchus. Its incubation period is 5 to 15 days.In China, JE epidemic peak season is
      from June to August and it mainly occurred in children. JE has ranked in top ten infectious
      diseases according to either incidence or mortality. JE vaccines are used to protect the
      population especially young children and infants from encephalitis diseases. Live attenuated
      JE vaccines are now widely used. They are directly produced from attenuated virus which may
      increase the possibility of virulence reversion. Many developed countries are using purified
      model inactivated JE vaccine. Therefore, it is an inevitable trend in China to develop a new
      generation of safer and more effective inactivated vaccine to prevent and control epidemic
      encephalitis.
    

Detailed description: 
      Japanese encephalitis (JE) is an acute viral zoonotic disease. Neurologic manifestations of
      the disease range from subtle changes in behavior to serious problems, including blindness,
      ataxia, weakness, and movement disorders. The Japanese encephalitis virus (JEV) occurs
      primarily in Southeast Asian. It is spread by culicine mosquitoes, most often Culex
      tritaeniorhynchus. Its incubation period is 5 to 15 days. In China, JE epidemic peak season
      is from June to August and it mainly occurred in children. JE has ranked in top ten
      infectious diseases according to either incidence or mortality. JE vaccines are used to
      protect the population especially young children and infants from encephalitis diseases. Live
      attenuated JE vaccines are now widely used. They are directly produced from attenuated virus
      which may increase the possibility of virulence reversion. Many developed countries are using
      purified model inactivated JE vaccine. Therefore, it is an inevitable trend in China to
      develop a new generation of safer and more effective inactivated vaccine to prevent and
      control epidemic encephalitis.

      In order to evaluate immunogenicity and safety of Vero cell-derived inactivated Japanese
      Encephalitis vaccine produced by Shandong Hengye Biotech Co., Ltd. a single-centre phase III
      clinical trial is planned to conduct in healthy infants aged 6-11 months in China.

      There will be two immunization programs. 600 healthy infants aged 6-11 months will be
      randomly assigned (1:1) to receive an experimental vaccine or a positive control vaccine at
      day 0,7. Another 300 healthy infants aged 6-11 months will be recruited to receive an
      experimental vaccine at day 0,28. All of them will be received a third dose as booster
      vaccination 12 months later.
    

Intervention name(s): 0.5ml experimental vaccine on day 0,7 Vero cell-derived inactivated Japanese Encephalitis vaccine; 0.5ml experimental vaccine on day 0,28 Vero cell-derived inactivated Japanese Encephalitis vaccine; 0.5ml active comparator vaccine on day 0,7 inactivated freeze-dried Japanese Encephalitis vaccine(Vero cell)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Vero cell-derived inactivated Japanese Encephalitis vaccine produced by Shandong Hengye Biotech Co., Ltd./0.5ml, two doses with 7 days interval, a booster dose 12 months after the first dose; Vero cell-derived inactivated Japanese Encephalitis vaccine produced by Shandong Hengye Biotech Co., Ltd./0.5ml, two doses with 28 days interval, a booster dose 12 months after the first dose; inactivated freeze-dried Japanese Encephalitis vaccine(Vero cell) produced by Beijing Tiantan Biological Products Co., Ltd. /0.5ml, two doses with 7 days interval, a booster dose 12 months after the first dose
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Japanese encephalitis; immunogenicity; safety; vaccine