Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine
Condition: Polio
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this phase I study is to evaluate the safety of a Sabin Inactivated Poliovirus
      Vaccine (sIPV) in adults and children, and the safety and immunogenicity of it in infants. 20
      adults aged 18~45 years and 20 children aged 4 years were only administered one dose of sIPV
      with medium D antigen content. 60 infants aged 2 months (60~90 days) were randomized to
      receive three doses of sIPV with medium D antigen content, conventional IPV (cIPV,
      manufactured by Sanofi Pasteur) or sIPV (manufactured by the Institute of Medical Biology,
      the Chinese Academy of Medical Biology), respectively, on the month 0, 1, 2 schedule. Serum
      samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to
      assess the immunogenicity in infants. Adverse events occurring within 30 days after each dose
      were collected to assess the safety.
    

Detailed description: 
      The purpose of this phase I study is to evaluate the safety of a Sabin Inactivated Poliovirus
      Vaccine (sIPV) in adults and children, and the safety and immunogenicity of it in infants. 20
      adults aged 18~45 years and 20 children aged 4 years were only administered one dose of sIPV
      with medium D antigen content. 60 infants aged 2 months (60~90 days) were randomized to
      receive three doses of sIPV with medium D antigen content, conventional IPV (cIPV,
      manufactured by Sanofi Pasteur) or sIPV (manufactured by the Institute of Medical Biology,
      the Chinese Academy of Medical Biology), respectively, on the month 0, 1, 2 schedule. Serum
      samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to
      assess the immunogenicity in infants. Adverse events occurring within 30 days after each dose
      were collected to assess the safety.

      The antigen contents of type I, type II and type III polioviruses in the investigational and
      control vaccines were as follows: medium-dose Sabin IPV (15 DU, 45 DU and 45 DU), control
      Sabin IPV (30 DU, 32 DU and 45 DU), control Salk IPV (40 DU, 8 DU and 32 DU). All vaccines
      were in liquid form, 0.5 ml per dose.
    

Intervention name(s): sIPV; Commercialized sIPV; Commercialized IPV
Intervention type(s): Biological; Biological; Biological
Intervention description(s): The Medium dosage sIPV was developed by Minhai Biotech Co., LTD. The antigen contents of type I, type II and type III polioviruses in the medium dosage sIPV were 15 DU, 45 DU and 45 DU. The vaccine was in liquid form, 0.5 ml per dose.; The commercialized sIPV was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.The antigen contents of type I, type II and type III polioviruses in the commercialized sIPV were 30 DU, 32 DU and 45 DU. The vaccine was in liquid form, 0.5 ml per dose.; The commercialized Salk IPV was manufactured by Sanofi Pasteur S.A.The antigen contents of type I, type II and type III polioviruses in the commercialized IPV were 40 DU, 8 DU and 32 DU. The vaccine was in liquid form, 0.5 ml per dose.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention