NCT04054492

To Evaluate the Immunogenicity and Safety of Sequential Immunization Schedules of Sabin IPV and bOPV

A Randomized, Multi-center, Controlled Clinical Trial for Evaluating the Immunogenicity and Safety of Sequential Immunization Schedules of Sabin IPV and bOPV

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 604 (actual)
• Sponsor: China National Biotec Group Company Limited · Industry
• Sex: All
• Age: 60 Days – 89 Days
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the immunogenicity and safety of sequential immunization schedules of Sabin IPV and bOPV.

Detailed description

A phase 4 clinical trial is designed to evaluate the safety and immunogenicity of different sequential immunization schedules of Sabin IPV and bOPV. To be specific, the subjects were divided into 3 groups. Group 1 received Sabin-IPV+bOPV+bOPV respectively at the age of 2,3,4 months old. Group 2 received Sabin-IPV+Sabin-IPV+bOPV respectively at the age of 2,3,4 months old. Group 3 received Sabin-IPV+Sabin-IPV+Sabin-IPV respectively at the age of 2,3,4 months old. Blood samples were collected before vaccination and 30 days after the third dose. Neutralization antibody against type I, Type II and Type III poliomyelitis virus were detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of the 3 immunization schedule groups were also monitored.

Conditions

• Vaccination
• Reaction - Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Sabin-IPV+bOPV+bOPV	202 subjects were vaccinated with 1 dose of Sabin-IPV and 2 doses of bOPV at their age of 2/3/4 months old, respectively
BIOLOGICAL	Sabin-IPV+Sabin-IPV+bOPV	197 subjects were vaccinated with 2 doses of Sabin-IPV and 1 dose of bOPV at their age of 2/3/4 months old, respectively
BIOLOGICAL	Sabin-IPV+Sabin-IPV+Sabin-IPV	205 subjects were vaccinated with 3 doses of Sabin-IPV at their age of 2/3/4 months old, respectively

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-01-25
• Completion: 2019-06-12
• First posted: 2019-08-13
• Last updated: 2019-08-13

Locations

1 site across 1 country: China