Polio Clinical Trial
Official title:
A Phase Ib Study to Evaluate the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Vero Cell)
The purpose of this phase Ib 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 high D antigen content. 20 infants aged 2 months (60~90 days) were administered three doses of sIPV with high D antigen content, 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 purpose of this phase Ib 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 high D antigen content. 20 infants aged 2 months (60~90 days) were
administered three doses of sIPV with high D antigen content, 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 high-dose Sabin IPV
were 22 DU, 65 DU and 65 DU. All vaccines were in liquid form, 0.5 ml per dose.
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