The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.

Detailed Description
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The Sabin IPV was manufactured with poliovirus type1, 2, 3 Sabin strains and Vero cells by micro-carrier culture in 550 liter bioreactors. The virus suspension was harvested ,ultra-concentrated, purified and inactivated with formalin. Three formulations A,B,C of Sabin IPV were used, the DAg contents for A were type1 45,type2 64,type3 67.5 DU /0.5ml/per dose; for B 30,32,45 DU/0.5ml/per dose; for C 15,16,22.5 DU/0.5ml/per dose. This is a randomized, double-blind, placebo control phase 1 clinical trial. Total 130 individuals were selected ,including adults (n=20), children(n= 20) and infants(n= 90). Adults were randomized to two groups A1(n=10) and A2(n=10).Group A1 received one dose of B ,one month later group A2 received one dose of A for safety observation. Children were randomized to two groups C1(n=10) and C2(n=10) and followed the same vaccination and safety observation procedures as adults. Infants were randomly allocated to three groups I-1,I-2,I-3 for safety and immunogenicity study. Group I-1 were vaccinated with three doses of C(n=15) or placebo (n=15) on day 0,30,60,serum samples were collected before and 30 days after dose 3 for detecting neutralization antibody. The same procedures were followed by GroupI-2 for B and group I-3 for A as groupI-1 with 30 days intermission.

Official Title
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The Phase I Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains

Conditions
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Poliomyelitis

Intervention / Treatment
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* Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)
* Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)
* Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females, age from 60 days to 60 years old; Routine blood assaying (white blood cell, red blood cell, hemoglobin), liver (alanine transaminase)and kidney(blood urea nitrogen) functions are normal before vaccination; Adults, parent(s) or guardians are able to understand and sign informed consent for participation; Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions; Infants no vaccinated with poliovaccine or other preventive biologicals in recent 7 days; Axillary temperature ≤37℃. Exclusion Criteria: Have medical record of participants or their family on allergy, convulsion, falling sickness, encephalopathy and psychopathy; Abnormal results of routine blood assaying (white blood cell, red blood cell, hemoglobin), liver (alanine transaminase)and kidney(blood urea nitrogen) functions before vaccination; Low platelet or bleeding disorder do not allow vaccination into the muscle; Have damaged or lower immunological function; Received blood, plasma or immunoglobulin treatment since birth; Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome ).

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: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infants I-1<br>Biological: Inactivated Poliomyelitis Vaccine (Sabin strains). Group I-1: 15 infants received 3 doses of formulation C vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart; | Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)<br>* 15 infants received 3 doses of formulation C vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.<br>* Other names: Sabin IPV,lot No.20080303;|
| Experimental: Infants I-2<br>15 infants received 3 doses of formulation B vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart; | Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)<br>* 15 infants received 3 doses of formulation B vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;<br>* Other names: Sabin IPV, lot No.20080302;|
| Experimental: Infant I-3<br>15 infants received 3 doses of formulation A vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart. | Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)<br>* 15 infants received 3 doses of formulation A vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.<br>* Other names: Sabin IPV, lot No.20080301;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does. |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inactivated Poliomyelitis Vaccine, Sabin Strains, poliomyelitis