Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine.

Study Overview
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Brief Summary
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This study is a randomized, blinded and controlled phase II study to evaluate the safety and immunogenicity of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Infants. A total of 600 infants aged 2 months (60 90 days) were randomized to receive five different vaccination regimens: three experimental groups (1, 2, and 3) received three doses of sIPV with high, medium, and low D antigen content, respectively, on the month 0,1,2 schedule; two control groups (4 and 5) received three doses of conventional IPV (cIPV, manufactured by Sanofi Pasteur) or sIPV (manufactured by the Institute of Medical Biology, the Chinese Academy of Medical Biology), respectively, on the same schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity. Adverse events occurring within 30 days after each dose were collected to assess the safety.

Official Title
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A Randomized, Blinded and Controlled Phase II Study to Evaluate the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Vero Cell) in Infants.

Conditions
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Polio and Post-Polio Syndrome

Intervention / Treatment
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* Biological: Three-dose regimen of high dosage investigational sIPV
* Biological: Three-dose regimen of medium dosage investigational sIPV
* Biological: Three-dose regimen of low dosage investigational sIPV
* Biological: Three-dose regimen of commercialized sIPV
* Biological: Three-dose regimen of commercialized IPV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteer aged 2 months (60 90 days) old without prior vaccination of poliovirus and any contraindication for vaccination; 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; Axillary temperature ≤ 37.0 °C; Exclusion Criteria: Preterm or low birth weight infants; Congenital malformation, developmental disorders, genetic defects, or severe malnutrition; History of polio; Severe nervous system disease (epilepsy, seizures or convulsions) or mental illness; 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; Autoimmune disease or immunodeficiency/immunosuppressive; Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder) , or significant bruising or coagulopathy; Serious chronic diseases, respiratory diseases, cardiovascular diseases, liver or kidney diseases or skin diseases; Mother of the participant has HIV infection; Acute illness or acute exacerbation of chronic disease within the past 7 days; Had a high fever within the past 3 days (axillary temperature ≥ 38.0°C); Receipt of any subunit or inactivated vaccine within the past 7 day; Receipt of any live attenuated vaccine within the past 14 days; Receipt of any blood product within the past 3 months; Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group - High dosage<br>Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of high dosage investigational sIPV | Biological: Three-dose regimen of high dosage investigational sIPV<br>* The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..<br>|
| Experimental: Experimental Group - Medium dosage<br>Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of medium dosage investigational sIPV | Biological: Three-dose regimen of medium dosage investigational sIPV<br>* The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..<br>|
| Experimental: Experimental Group - Low dosage<br>Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of low dosage investigational sIPV | Biological: Three-dose regimen of low dosage investigational sIPV<br>* The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..<br>|
| Active Comparator: Control Group -commercialized sIPV<br>Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of commercialized sIPV | Biological: Three-dose regimen of commercialized sIPV<br>* The control vaccine was manufactured by Chinese Academy of Medical Sciences.<br>|
| Active Comparator: Control Group -commercialized IPV<br>Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of commercialized IPV | Biological: Three-dose regimen of commercialized IPV<br>* The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO).<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 three-dose regimen | 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. | 28 42 days | 
| The post-immune geometric mean titer (GMT) of each group after three-dose regimen | GMT of each group 28 42 days after three-dose regimen. | 28 42 days | 
| The geometric mean fold increase (GMI) of each group after three-dose regimen | The GMI is the increase of post-immune GMT from pre-immune GMT. | 28 42 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 incidences of serious adverse events (SAEs) of each group | SAEs occurred within 30 days after each injection will be collected. | 30 days |