Immunogenicity and Safety Evaluation of Different Sequential Immunization Strategies by Sabin IPV and bOPV in Chinese Infants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the immunogenicity and safety of different sequential immunization strategies by Sabin IPV and bOPV in Chinese infants.

Official Title
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Immunogenicity and Safety Evaluation of Different Sequential Immunization Strategies by Sabin IPV and bOPV in Chinese Infants

Conditions
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Polio

Intervention / Treatment
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* Biological: Sabin IPV+ bOPV+ bOPV
* Biological: Sabin IPV + Sabin IPV + bOPV
* Biological: Sabin IPV + Sabin IPV + Sabin IPV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent. Participant is aged ≥ 60 days to ≤ 75 days. Participant without preventive inoculation of polio vaccine and previous history of Polio. Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures. Body temperature ≤ 37.5℃. Exclusion Criteria: Known allergy to any constituent of the vaccine. Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever. Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth. Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction. Known bleeding disorder. Receipt of the whole blood, blood plasma or immunoglobulin before the trial vaccination. Reported the history of acute illness had need systemic antibiotics or antiviral treatment of infections in the 7 days preceding the trial vaccination. An acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial. Participation in any other intervention clinical trial. Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine.

Ages Eligible for Study
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Minimum Age: 60 Days
Maximum Age: 75 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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>The sequential immunization strategy for group 1 on polio was Sabin IPV+ bOPV + bOPV. | Biological: Sabin IPV+ bOPV+ bOPV<br>* Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.<br>|
| Experimental: Group 2<br>The sequential immunization strategy for group 2 on polio was Sabin IPV + Sabin IPV + bOPV. | Biological: Sabin IPV + Sabin IPV + bOPV<br>* Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.<br>|
| Experimental: Group 3<br>The sequential immunization strategy for group 3 on polio was Sabin IPV + Sabin IPV + Sabin IPV. | Biological: Sabin IPV + Sabin IPV + Sabin IPV<br>* Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| seroconversion rate | any positive antibody response in infants who were seronegative prior to their first dose, or at least a fourfold increase in type-specific antibody levels for infants who had pre-existing antibodies. | seroconversion rate was evaluated 4-5 weeks after the third dose of polio vaccine. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety: rate of adverse events | the rate of adverse events. | At least 2 active surveillance visits (3 days and 30 days) were required after each vaccination to collect adverse reaction data. | 
| neutralizing antibody titer |  | Blood samples were obtained prior to the first dose and 4-5 weeks after the third dose of polio vaccine. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunogenicity, Safety, Sabin IPV, bOPV