Immunogenicity and Safety of Sabin-IPV Replacement Vaccination

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vaccination

Intervention / Treatment
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* Biological: Inactivated Polio Vaccine


Participation Criteria
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Eligibility Criteria
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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 vaccines 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;

Ages Eligible for Study
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Minimum Age: 60 Days
Maximum Age: 89 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1<br>180 2-month-old subjects will be enrolled with vaccination schedule as follows: 1st: Salk-IPV; 2nd: Sabin-IPV; 3rd: Sabin-IPV | Biological: Inactivated Polio Vaccine<br>* Inactivated Polio Vaccine at age of 2,3,4 months old, respectively<br>|
| Active Comparator: group 2<br>180 2-month-old subjects will be enrolled with vaccination schedule as follows: 1st: Salk-IPV; 2nd: Salk-IPV; 3rd: Salk-IPV | Biological: Inactivated Polio Vaccine<br>* Inactivated Polio Vaccine at age of 2,3,4 months old, respectively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate | determine the seroconversion rate of both groups | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutralizing antibody titers | Measure neutralizing antibody titers against poliovirus type I, II and III | 4 months |