Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP

Study Overview
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Brief Summary
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Eligible,healthy infants will be recruited and divided into 3 groups:(1)combined immunization of sIPV and DTaP group, (2) sIPV group and (3) DTaP group. After completing the two basic vaccine EPI procedures, the immunogenicity and safety of the combined immunization group and the individual vaccination groups will be compared and analyzed.

Detailed Description
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It is recommended by China Food and Drug Administration (CFDA) that studies on simultaneous immunization of Sabin-IPV and DTaP be carried out as soon as possible, and the immunogenicity and safety studies should also be conducted. Currently in China the vaccination schedules of sIPV and DTaP overlap at infants' 3rd and 4th months of age. In order to avoid the vaccination time conflict and explore the possibility of simultaneous vaccination, we design this clinical study of simultaneous vaccination of the two vaccines. To be specific, the subjects were divided into 3 groups. Group 1 : sIPV (1st, 2nd, and 3rd doses) and DTaP (1st, 2nd, and 3rd doses) were simultaneously inoculated at 3,4,5 months old ; Group 2 : received 1 dose of sIPV at 3,4,5 months old ; Group 3 : received 1 dose of DTaP at 3,4,5 months old . Blood sample would be collected both before vaccination and 28-40 days after the 3rd dose of vaccination. Neutralization antibody would also be detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedule will be monitored as well.

Official Title
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A Randomized, Controlled, Multicenter Vaccine Clinical Trial to Evaluate The Safety and Immunogenicity of Combined Immunization With sIPV and DTaP

Conditions
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Vaccination

Intervention / Treatment
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* Biological: Sabin-IPV and DTaP
* Biological: Sabin-IPV
* Biological: DTaP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects aged 3 months 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 have not been vaccinated with IPV vaccine, OPV vaccine, DTP vaccine and related vaccines; Exclusion Criteria: subject who has a medical history with Hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness; allergic to any ingredient of vaccine or with allergy history to any vaccine; subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone); administration of immunoglobulins within 30 days prior to this study; acute febrile disease(temperature ≥ 37.0°C) or infectious disease; have a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection; any serious chronic illness, acute infectious diseases, or respiratory diseases; severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications; any kind of infectious, purulent, or allergic skin 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: 3 Months
Maximum Age: 3 Months

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>234 subjects; simultaneously administration of Sabin-IPV and DTaP at the age of 3/4/5 months old, 0.5 ml each dose, respectively | Biological: Sabin-IPV and DTaP<br>* Sabin-IPV +DTaP at the age of 3/4/5 months old respectively<br>|
| Active Comparator: group 2<br>234 subjects; Sabin-IPV only at the age of 3/4/5 months old, 0.5 ml each dose, respectively | Biological: Sabin-IPV<br>* Sabin-IPV only at the age of 3/4/5 months old respectively<br>|
| Active Comparator: group 3<br>234 subjects; DTaP only at the age of 3/4/5 months old, 0.5 ml each dose, respectively | Biological: DTaP<br>* DTaP only at the age of 3/4/5 months old respectively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate I | determine the rate of positive seroconversion against poliovirus type I, II and III of the 3 groups | 1 month after the 3rd dose | 
| Seroconversion rate II | determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the 3 groups | 1 month after the 3rd dose | 
| Neutralizing antibody titers I | Measure neutralizing antibody titers against poliovirus type I, II and III | 1 month after the 3rd dose | 
| Neutralizing antibody titers II | Measure neutralizing antibody titers against diphtheria, pertussis toxoid, pertussis filamentous hemagglutinin, and tetanic of the 3 groups | 1 month after the 3rd dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety outcomes | Adverse event following vaccinations | 6 months |