An Immunogenicity and Safety Study of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in 2-month-old Infants

Study Overview
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Brief Summary
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The purpose of this phase III study is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) in 2-month-old infants.

Detailed Description
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The study is a randomized, double-blind, controlled randomized, double-blind, controlled clinical trial clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) manufactured by Sinovac Vaccine Technology Co., Ltd in 2-month-old infants. The control vaccine is a commercialized Inactivated Poliovirus Vaccine manufactured by Sanofi Pasteur company. 1200 healthy infants between 60-90 days will be randomly assigned into experimental group or control group in the ratio 1:1.

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 2-month-old Infants

Conditions
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Poliomyelitis

Intervention / Treatment
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* Biological: Investigational sIPV
* Biological: Control IPV


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 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 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>The investigational vaccine was manufactured by Sinovac Vaccine Technology Co., Ltd. Intervention: investigational sIPV | Biological: Investigational sIPV<br>* Three intramuscular injections of the investigational vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Single intramuscular injection of the investigational vaccine (0.5 ml) at 18 months; Intervention: investigational sIPV<br>|
| Active Comparator: Control Group<br>The control vaccine was manufactured by Sanofi Pasteur Company. Intervention: control IPV | Biological: Control IPV<br>* Three intramuscular injections of the control vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Single intramuscular injection of the control vaccine (0.5 ml) at 18 months; Intervention:control IPV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The seroconversion rates (SCRs) of each group after primary immunization. | 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). | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidences of solicited adverse events (AEs) of each group. | Solicited AEs occurred within 7 days after each injection will be collected. | 7 days | 
| The incidences of unsolicited adverse events (AEs) of each group. | Unsolicited AEs occurred within 30 days after each injection will be collected. | 30 days | 
| The incidence of serious adverse events (SAEs) during the period of safety monitoring of each group. | SAEs during the period of safety monitoring will be collected. | 90-420 days. | 
| The post-immune 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). | 90 days | 
| The post-immune geometric mean titer (GMT) of each group after primary immunization. | GMT of each group after primary immunization which lasts 60 days. | 90 days. | 
| The geometric mean fold increase (GMI) of each group after primary immunization. | The GMI is the increase of post-immune GMT from pre-immune GMT. | 90 days | 
| The percentage of subjects with antibody ≥ 1:64 of each group after primary immunization. | Percentage of subjects with antibody ≥ 1:64 of each group after three-dose | 90 days | 
| The antibody positive rate of each group before booster dose. | Subjects whose post-immune antibody level ≥ 1:8 are considered antibody positive. A booster dose at the age of 18months. | 420 days | 
| The geometric mean titer (GMT) of each group before booster dose. | GMT of each group before booster dose which occurred at the age of 18months. | 420 days. | 
| The geometric mean fold increase (GMI) of each group before booster dose. | The GMI is the increase of post-immune GMT from pre-i mmune GMT. | 420 days | 
| The percentage of subjects with antibody ≥ 1:64 of each group before booster dose. | Percentage of subjects with antibody ≥ 1:64 of each group before booster dose which occurred at the age of 18months. | 420 days | 
| The post-immune antibody positive rate of each group after booster dose. | Subjects whose post-immune antibody level ≥ 1:8 are co nsidered antibody positive | 570 days | 
| The post-immune geometric mean titer (GMT) of each group after booster dose. | GMT of each group after booster dose. The booster dose at the age of 18months | 570 days | 
| The geometric mean fold increase (GMI) of each group after booster dose. | The GMI is the increase of post-immune GMT from pre-immune GMT. | 570 days | 
| The percentage of subjecs with antibody ≥ 1:64 of each group after booster dose. | Percentage of subjecs with antibody ≥ 1:64 of each group after booster dose which occurred at the age of 18months. | 570 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