Evaluation of the Safety and Immunogenicity of Simultaneously Administration of sIPV and DTaP

Study Overview
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Brief Summary
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Subjects will be recruited and divided into 3 groups:(1)combined immunization of Sabin-IPV and DTaP, (2) Sabin-IPV only and (3) DTaP only. After finishing the two basic vaccine EPI procedures, the immunogenicity and safety of both combined immunization group and individual vaccination groups will be compared and the data will be 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 implemented soon and the immunogenicity and safety studies should be conducted. In China according to the current vaccination schedule, the arrangement of Sabin-IPV and DTaP falls on the same date -- at infants' 3rd and 4th months of age. In order to avoid the vaccination time conflict and explore the feasibility of simultaneous immunization, we design this phase 4 clinical trial of simultaneous vaccination of the two vaccines. To be specific, the subjects were divided into 3 groups. Group 1 : Sabin-IPV (1st, 2nd, and 3rd doses) and DTaP (1st, 2nd, and 3rd doses) are simultaneously administrated at 3,4,5 months old ; Group 2 : subjects receive 1 dose of sIPV only at 3,4,5 months old ; Group 3 : subjects receive 1 dose of DTaP only at 3,4,5 months old . Blood samples would be collected both before vaccination and 28-40 days after the 3rd dose of vaccination. Neutralization antibody will be detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedules will be monitored too.

Official Title
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A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Simultaneously Administration of 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, cerebropathy and neurological illness; allergic to any ingredient of vaccine or with allergy history to any vaccine; subjects with immunodeficiency 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: Sabin-IPV and DTaP<br>234 subjects are simultaneously administrated with 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>* simultaneously administration of Sabin-IPV and DTaP<br>|
| Active Comparator: Sabin-IPV only<br>234 subjects are administrated with Sabin-IPV only at the age of 3/4/5 months old, 0.5 ml each dose, respectively | Biological: Sabin-IPV<br>* administration of Sabin-IPV only<br>|
| Active Comparator: DTaP only<br>234 subjects are administrated with DTaP only at the age of 3/4/5 months old, 0.5 ml each dose, respectively | Biological: DTaP<br>* administration of DTaP only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rates at both baseline and 30 days after the 3rd vaccination | Determine the seroconversion rates of diphtheria, tetanus, pertussis, poliovirus (types I,II,III). Diphtheria titers are determined by toxin neutralization assay; tetanus titers are determined by enzyme-linked immunosorbent assay (ELISA) | 4 months | 
| Neutralizing antibody titers at both baseline and 30 days after the 3rd vaccination | Measure neutralizing antibody titers against: (1) poliovirus type I, II and III，(2) anti-pertussis toxoid ,(3) anti- FHA,(4) anti-diphtheria toxoid and (5) anti-tetanic antibodies | 4 months | 
| numbers of participants who experience adverse events | analyse the numbers and rates of participants who have adverse events following immunization | 6 months |