NCT04051736

Immunogenicity and Safety of Sabin-IPV Replacement Vaccination

a Randomized, Controlled Clinical Trial of Immunogenicity and Safety of Sabin-based Inactivated Polio Vaccine Replacing Salk-based Inactivated Polio Vaccine

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: China National Biotec Group Company Limited · Industry
• Sex: All
• Age: 60 Days – 89 Days
• Healthy volunteers: Accepted

Summary

This study replaced the 2nd and 3rd dose of Salk-IPV (produced by Sanofi) with Sabin-IPV (produced by CNBG) and then reviewed the safety and immunogenicity of the vaccination, aiming to acquire scientific evidence for the feasibility of immunization involving different viral strains replacement.

Detailed description

It is required by China Food and Drug Administration (CFDA) that considering in the real situation IPV receivers may be immuned by different viral strains of this vaccine, a phase 4 clinical trial aiming to demonstrate the safety and immunogenicity of the immunization schedule should be carried out. To be specific, the subjects were divided into 2 groups. Group 1 received Salk-IPV+Sabin-IPV+Sabin-IPV respectively at the age of 2,3,4 months old. Group 2 received Salk-IPV+Salk-IPV+Salk-IPV respectively at the age of 2,3,4 months old. Blood sample was collected before vaccination and 30 days after the third dose of vaccination. 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 both immunization schedule will also been monitored.

Conditions

• Vaccination

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated Polio Vaccine	Inactivated Polio Vaccine at age of 2,3,4 months old, respectively

Timeline

• Start date: 2018-03-01
• Primary completion: 2018-12-28
• Completion: 2020-08-31
• First posted: 2019-08-09
• Last updated: 2020-09-09

Locations

1 site across 1 country: China