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

Phase 4

Completed

• Conditions: Reaction - Vaccine; Vaccination
• Interventions: Biological: Sabin-IPV+Sabin-IPV+bOPV; Biological: Sabin-IPV+Sabin-IPV+Sabin-IPV; Biological: Sabin-IPV+bOPV+bOPV

• Registration Number: NCT04054492
• Lead Sponsor: China National Biotec Group Company Limited

Brief 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.

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2019-01-25
• Study Completion: 2019-06-12
• Status Verified: 2019-08
• Study First Submitted: 2019-08-09
• Study First Submitted QC: 2019-08-11
• Last Update Submitted: 2019-08-11
• Study First Posted: 2019-08-13
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 604

Inclusion Criteria

• subjects aged from 60 days to 89 days old at the date of recruitment;
• with informed consent signed by parent(s) or guardians;
• parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions;
• subjects did not receive any vaccination within 14 days;
• axillary temperature ≤37.0℃

Exclusion Criteria

• allergic to any ingredient of vaccine or with allergy history to any vaccine;
• acute febrile disease or infectious disease;
• serious chronic diseases;
• any other factor that makes the investigator determines the subject is unsuitable for this study;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sIPV+sIPV+bOPV	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
sIPV+sIPV+sIPV	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
sIPV+bOPV+bOPV	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

Primary Outcome Measures

Name	Time	Method
Seroconversion rates at both baseline and 30 days after the 3rd vaccination	4 months	Determine the seroconversion rates of poliovirus (types I,II,III）at both baseline and 30 days after the 3rd vaccination

Secondary Outcome Measures

Name	Time	Method
Neutralizing antibody titers at both baseline and 30 days after the 3rd vaccination	4 months	Measure neutralizing antibody titers against poliovirus type I, II and III at both baseline and 30 days after the 3rd vaccination

Trial Locations

Locations (1)

Inner Mongolia Autonomous Region Center for Diseases Prevention and Control; 🇨🇳 Hohhot, Inner Mongolia Autonomous Region, China