Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine.

Polio and Post-Polio Syndrome Clinical Trial

Official title: A Randomized, Blinded and Controlled Phase II Study to Evaluate the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Vero Cell) in Infants.

Status Completed

Clinical Trial Summary

This study is a randomized, blinded and controlled phase II study to evaluate the safety and immunogenicity of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Infants. A total of 600 infants aged 2 months (60~90 days) were randomized to receive five different vaccination regimens: three experimental groups (1, 2, and 3) received three doses of sIPV with high, medium, and low D antigen content, respectively, on the month 0,1,2 schedule; two control groups (4 and 5) received three doses of 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 same schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity. Adverse events occurring within 30 days after each dose were collected to assess the safety.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Polio and Post-Polio Syndrome
• Postpoliomyelitis Syndrome

• NCT number: NCT03902054
• Study type: Interventional
• Source: Jiangsu Province Centers for Disease Control and Prevention
• Status: Completed
• Phase: Phase 2
• Start date: December 28, 2017
• Completion date: December 28, 2018