A Clinical Trial to Evaluate the Immunogenicity and Safety of sIPV in a 2+1Sequential Schedule With bOPV in Infants

Study Overview
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Brief Summary
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The purpose of this phrase III clinical trial is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) in a '2+1'sequential schedule with bivalent oral poliovirus vaccine in 2-month-old infants

Detailed Description
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his study is a randomized, double-blind, active-controlled phrase III clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of sIPV manufactured by Sinovac Biotech Co., Ltd in a '2+1' sequential schedule with bOPV in 2-month-old infants. 240 infants aged between 60-90 days will be randomly assigned into experimental group or control group in the ratio 1:1. The experimental group received sIPV-sIPV-bOPV vaccination schedule at one month doses interval (i.e., month 0, 1, 2), and the control group received wIPV-wIPV-bOPV vaccination schedule at one month doses interval (i.e., month 0, 1, 2). The control wIPV was manufactured by SANOFI PASTEUR S.A.

Official Title
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A Randomized, Double-blind, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in a '2+1'Sequential Schedule With Bivalent Oral Poliovirus Vaccine in 2-month-old Infants

Conditions
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Poliomyelitis

Intervention / Treatment
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* Biological: sIPV-sIPV-bOPV vaccination schedule
* Biological: wIPV-wIPV-bOPV vaccination schedule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteer between 60-90 days old; Healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators; Proven legal identity; Participants or guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment; Complying with the requirement of the study protocol; Exclusion Criteria: Prior vaccination with Poliovirus Vaccine; History of allergy to any vaccine, or any ingredient, excipients and Gentamycin Sulfate of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc; Congenital malformation, developmental disorders, genetic defects, or severe malnutrition; Autoimmune disease or immunodeficiency/immunosuppressive; Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness; Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders; Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) prior to study entry; Blood product prior to study entry; Any other investigational medicine(s) within 30 days prior to study entry; Any live attenuated vaccine within 14 days prior to study entry; Any subunit vaccine or inactivated vaccine within 7 days prior to study entry; Acute disease or acute stage of chronic disease within 7 days prior to study entry; Axillary temperature > 37.0 °C; Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;

Ages Eligible for Study
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Minimum Age: 60 Days
Maximum Age: 90 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>sIPV-sIPV-bOPV vaccination schedule | Biological: sIPV-sIPV-bOPV vaccination schedule<br>* Two intramuscular injections of the investigational vaccine (0.5 ml) on Day 0 and Day 30 respectively; Single dose of bOPV (0.1 ml) on Day 60. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by Sinovac Biotech Co., Ltd . The poliovirus (Live) vaccine type I & type III (Human Diploid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.<br>|
| Active Comparator: Control Group<br>wIPV-wIPV-bOPV vaccination schedule | Biological: wIPV-wIPV-bOPV vaccination schedule<br>* Two intramuscular injections of the control vaccine(0.5 ml) on Day 0 and Day 30 respectively; Single dose of bOPV (0.1 ml) on Day 60. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by SANOFI PASTEUR S.A. The poliovirus (Live) vaccine type I & type III (Human Diploid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference between experimental group and control group of type I,III neutralizing antibody seroconversion rate after primary immunization. And the lower limit of 95% confidence intervals of the difference value. | Subjects whose pre-immune antibody level < 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted. Primary vaccination schedule: 3 doses with one month interval between doses (i.e., month 0, 1, 2). | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidences of solicited adverse events (AEs) within 7 or 14 days after each dose of each group. | Solicited AEs occurred within 7 days (for sIPV) or 14 days (for bOPV) after each injection will be collected. | 7 days or 14 days | 
| The incidence of unsolicited AE within 30 days after each dose of each group. | Unsolicited AEs occurred within 30 days after each injection will be collected. | 30 days | 
| Incidence of serious adverse events (SAEs) during the period of safety monitoring. | SAEs during the period of safety monitoring will be collected. | 30 days | 
| Type I,II and III neutralizing antibody positive rate of each group after primary immunization | Subjects whose post-immune antibody level ≥ 1:8 are considered antibody positive. Primary vaccination schedule: 3 doses with one month interval between doses (i.e., month 0, 1, 2). | 30 days | 
| Type I,II and III post-immune geometric mean titer (GMT) of each group after primary immunization. | GMT of each group after primary immunization | 30 days | 
| Type I,II and III post-immune geometric mean fold increase (GMI) of each group after primary immunization. | The GMI is the increase of post-immune GMT from pre-immune GMT. | 30 days | 
| Type I,II and III percentage of subjects with post-immune antibody level ≥1:64 of each group after primary immunization. | Subjects whose post-immune antibody level ≥ 1:64 will be collected. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sabin strain, Inactivated poliovirus vaccine, poliomyelitis, safety, immunogenicity, infant, sequential schedule