Consistency Study for Three Commercial Lots of Inactivated Poliomyelitis Vaccine Made From Sabin Strain

Study Overview
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Brief Summary
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A randomized and blind clinical consistency study for three commercial batches of Inactivated Poliomyelitis Vaccine Made From Sabin Strain (sIPV) for immunogenicity and safety evaluation.

Detailed Description
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This randomized and blind clinical study includes three test groups with 400 infants for each group. Sample estimation for this study has been conducted using statistical methods. A total of 1,200 2-month old healthy subjects were enrolled for inoculation of vaccine from 3 different lots with 1 month interval. All subjects received blood collection for immunogenicity test before and after primary immunization for evaluation of immunogenicity consistency, while safety observation was conducted within 30 days after each vaccination (30min via close safety monitoring, 0-7 days via participant diary card and 8-30 days via contact card for collection of adverse events) for safety evaluation of sIPV of 3 commercial lots.

Official Title
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Consistency Study for Three Commercial Lots of Inactivated Poliomyelitis Vaccine Made From Sabin Strain

Conditions
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Poliomyelitis

Intervention / Treatment
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* Biological: sIPV batch 1
* Biological: sIPV batch 2
* Biological: sIPV batch 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy infants of 2 months of age The legal identity certificate (birth/household register) and vaccination certificate of the participants can be provided, and the legal guardian can provide the legal identity certificate (identity card). Guardians are able to understand the experimental vaccine, volunteer to participate in the study and sign informed consent for participation. Guardians are capable of using thermometer, graduated scale, filling diary card and contact card. Participants are not vaccinated with polio vaccine and immunoglobulin (except for Hepatitis b specific immunoglobulin) after birth, no vaccination of live vaccine within 28 days before enrollment and no vaccination of inactivated vaccine within 14 days before enrollment. Participants or guardians are able to obey and follow all study instructions, complete all the monitoring, and cooperate to complete collection of blood sample. Axillary temperature ≤37℃ Exclusion Criteria: Allergic to any active substance, inactive substance or materials used during production such as kanamycin. Patients with fever or acute disease. Have thrombocytopenia or hemorrhagic diseases Patients undergoing immunosuppressive therapy or immunodeficiency Have uncontrolled epilepsy or other progressive neurological disorders Other situations that the investigator consider as non-eligible

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 3 Months

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Batch 1 of sIPV<br>The first commercial batch of sIPV | Biological: sIPV batch 1<br>* Type I 30 DU, Type II 32 DU, Type III 45 DU<br>|
| Experimental: Batch 2 of sIPV<br>The second commercial batch of sIPV | Biological: sIPV batch 2<br>* Type I 30 DU, Type II 32 DU, Type III 45 DU<br>|
| Experimental: Batch 3 of sIPV<br>The third commercial batch of sIPV | Biological: sIPV batch 3<br>* Type I 30 DU, Type II 32 DU, Type III 45 DU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate of neutralizing antibody | Blood samples were collected before and after immunization. Seroconversion rate of serum neutralizing antibody was determined. Intergroup differences analysis of the post-immunization positive conversion and ≥4-fold increase rate of antibody was performed. | 1 month after primary immunization | 
| Local and systemic adverse reactions | Safety monitoring for local and systemic adverse reaction within 30 days after 3-dose primary immunization via close monitoring or diary card. | Within 1 month after primary immunization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GMT of neutralizing antibody | Blood samples were taken before and after immunization for the determination of antibody level of serum neutralizing antibody. Intergroup differences analysis of antibody level was conducted. | 1 month after primary immunization |