A Clinical Trial of Quadrivalent Influenza Vaccine in Children Aged 3-8 Years Old
Condition: Seasonal Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label, randomized and controlled phase Ⅳ clinical trial of quadrivalent
      influenza vaccine manufactured by Sinovac Biotech Co. , the purpose of this study is to
      compare the immunogenicity and safety after 1 dose of quadrivalent influenza vaccine with
      that of 2 doses in vaccine-unprimed children aged 3-8 years old,to compare the immunogenicity
      and safety after 1 dose of quadrivalent influenza vaccine in vaccine-unprimed children aged
      3-8 years old with that of 1 dose in vaccine-primed children and to compare the
      immunogenicity and safety after 2 doses of quadrivalent influenza vaccine in vaccine-unprimed
      children aged 3-8 years old with that of 1 dose in vaccine-primed children.
    

Detailed description: 
      This study is open-label, randomized and controlled phase Ⅳ clinical trial of quadrivalent
      influenza vaccine.The purpose of this study is to compare the immunogenicity and safety after
      1 dose of quadrivalent influenza vaccine with that of 2 doses in vaccine-unprimed children
      aged 3-8 years old,to compare the immunogenicity and safety after 1 dose of quadrivalent
      influenza vaccine in vaccine-unprimed children aged 3-8 years old with that of 1 dose in
      vaccine-primed children and to compare the immunogenicity and safety after 2 doses of
      quadrivalent influenza vaccine in vaccine-unprimed children aged 3-8 years old with that of 1
      dose in vaccine-primed children.A total of 600 subjects including 400 vaccine-unprimed
      children and 200 vaccine-primed children will be enrolled,400 vaccine-unprimed children will
      be randomly divided into two groups in a 1:1 ratio.Subjects in group 1(experimental group 1 )
      will receive two doses of quadrivalent influenza vaccine on the immunization schedule of day
      0,28 and subjects in group 2 (experimental group 2) will receive one dose of quadrivalent
      influenza vaccine.200 vaccine-primed children (experimental group 3) will receive one dose of
      quadrivalent influenza vaccine.
    

Intervention name(s): Two doses of quadrivalent influenza vaccine; One dose of quadrivalent influenza vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 15ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administation is Intramuscular injection into deltoid region.And the immunization schedule is two doses of quadrivalent influenza vaccine on day 0, 28.; 15ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administation is Intramuscular injection into deltoid region.And the immunization schedule is one dose of quadrivalent influenza vaccine on day 0.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention