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

China National Biotec Group Company Limited604 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

604

Conditions

Vaccination Reaction - Vaccine

Interventions

Sabin-IPV+bOPV+bOPVBIOLOGICAL

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

Sabin-IPV+Sabin-IPV+bOPVBIOLOGICAL

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

Sabin-IPV+Sabin-IPV+Sabin-IPVBIOLOGICAL

205 subjects were vaccinated with 3 doses of Sabin-IPV at their age of 2/3/4 months old, respectively

Eligibility

Sex: ALLMin age: 60 DaysMax age: 89 DaysHealthy volunteers:

Medical Language ↔ Plain English

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;

Locations (1)

Inner Mongolia Autonomous Region Center for Diseases Prevention and Control

Hohhot, Inner Mongolia, China

Outcomes

Primary Outcomes

Seroconversion rates at both baseline and 30 days after the 3rd vaccination

Determine the seroconversion rates of poliovirus (types I,II,III）at both baseline and 30 days after the 3rd vaccination

Time frame: 4 months

Secondary Outcomes

Neutralizing antibody titers at both baseline and 30 days after the 3rd vaccination

Measure neutralizing antibody titers against poliovirus type I, II and III at both baseline and 30 days after the 3rd vaccination

Time frame: 4 months

Data from ClinicalTrials.gov

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