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

Study Overview
=================
Brief Summary
-----------------
Based on pre-clinical trial and phase 1 clinical data and principle of GCP, the objective of phase Ⅱ clinical trial is to evaluate safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains(Sabin IPV).

Detailed Description
-----------------
The Sabin IPV was manufactured with poliovirus type1, 2, 3 Sabin strains and Vero cells by microcarrier 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. Oral Poliomyelitis Vaccine(OPV)was manufactured by Institute of Medical Biology, Chinese Academy of Medical Sciences.Trivalent OPV contains Polioviruses Type 1 6.0 log CCID Type 2 5.0 log Type 3 5.5log /0.1ml/per dose Inactivated Poliomyelitis Vaccine (Salk strains)was manufactured by Sanofi Pasteur DAg contents /0.5ml/per dose were Type 1 40 DU,Type 2 8DU,Type 3 32DU. This is a randomized, blind phase 2 clinical trial. Total 500 infants (ages 60 days to 90 days) were selected , randomized to five groups(each group n=100) Sabin IPV formulations A,B,C,OPV ,Salk IPV were separately given to each group with three doses one month apart respectively.

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

Conditions
-----------------
Poliomyelitis

Intervention / Treatment
-----------------
* Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)
* Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)
* Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)
* Biological: Oral Poliomyelitis Vaccine
* Biological: Inactivated Poliomyelitis Vaccine (Salk strains).


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females, age from 60 days to 90 days; 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; 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 ); Have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, HIV. Exclusion Criteria for doses 2 and 3 Have serious anaphylaxis or high fever, convulsion during first dose; Have any circus of Exclusion Criteria after Eligible for study; Have serious adverse event which related to previous vaccination; Withdrawal and Discontinuance Criteria; Received necessary or interference study drugs such as: immune-inhibition or immune-stimulating agents; Vaccinated with any other vaccine（except DTP）; Stop observation determined by investigator owing to occurring serious adverse event;

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Experiment Infants<br>Biological: Inactivated Poliomyelitis Vaccine (Sabin strains) formulation A. 3x0.5ml intramuscular injections; | Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)<br>* Inactivated Poliomyelitis Vaccine (Sabin strains) formulation A. 3x0.5ml intramuscular injections,one month apart.<br>* Other names: Sabin IPV;|
| Experimental: Cohort 2: Experiment infants<br>Biological: Inactivated Poliomyelitis Vaccine (Sabin strains) formulation B. 3x0.5ml intramuscular injections; | Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)<br>* Inactivated Poliomyelitis Vaccine (Sabin strains) formulation B. 3x0.5ml intramuscular injections, one month apart.<br>* Other names: Sabin IPV;|
| Experimental: Cohort 3: Experiment infants<br>Biological: Inactivated Poliomyelitis Vaccine (Sabin strains) formulation C. 3x0.5ml intramuscular injections; | Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)<br>* Inactivated Poliomyelitis Vaccine (Sabin strains) formulation C. 3x0.5ml intramuscular injections, one month apart.<br>* Other names: Sabin IPV;|
| Experimental: Cohort 4: Experiment infants<br>Biological: Oral Poliomyelitis Vaccine (OPV).3x0.1ml oral; | Biological: Oral Poliomyelitis Vaccine<br>* Oral Poliomyelitis Vaccine (OPV).3x0.5mloral, one month apart.<br>* Other names: OPV;|
| Experimental: Cohort 5: Experiment infants<br>Biological: Inactivated Poliomyelitis Vaccine (Salk strains). 3x0.5ml intramuscular injections; | Biological: Inactivated Poliomyelitis Vaccine (Salk strains).<br>* 3x0.5ml intramuscular injections, one month apart.<br>* Other names: Salk IPV;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

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