A Clinical Study to Evaluate the Safety and Immunogenicity of Inactivated Poliomyelitis Vaccine in Healthy Infants

Study Overview
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Brief Summary
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The purpose of the study is to evaluate safety and immunogenicity of inactivated poliomyelitis vaccine based on Sabin strain (LBVC) in healthy infants to select optimal dose of LBVC as well as to demonstrate the lot-to-lot consistency and non-inferiority of LBVC.

Official Title
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A Prospective, Multi-national, Multi-center, Double-blind, Randomized, Active Controlled, Parallel-group, Seamless Phase II/III Clinical Study to Evaluate the Safety and Immunogenicity of 'LBVC (Sabin Poliomyelitis Vaccine (Inactivated))' Compared With 'Imovax® Polio (Poliomyelitis Vaccine (Inactivated))' in Healthy Infants

Conditions
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Poliomyelitis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy infants of either sex who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of enrollment Born at full term of pregnancy (Gestational age ≥37 weeks) Body weight ≥ 3.2 kg at the time of screening Born to HIV negative mother The parents or Legally Acceptable Representative (LAR) able to understand and comply with planned study procedures Signed informed consent by subject's parents or Legally Acceptable Representative (LAR) Exclusion Criteria: Previously received any polio vaccines (OPV or IPV) History of previous or concurrent vaccinations other than HepB, BCG, DTP, Hib, Rotavirus vaccine and PCV History of bleeding disorder contraindicating intramuscular injection. Experienced fever ≥ 38 °C/ 100.4 °F within the past 3 days prior to the screening Receipt of immunoglobulin or blood-derived product since birth History of allergic reactions to any vaccine components, including excipients and preservatives (neomycin, streptomycin and polymyxin B, etc.) Known or suspected immune disorder, or received immunosuppressive therapy History of poliomyelitis History of any neurological disorders or seizures Known or suspected febrile, acute or progressive illness Household contact and/or intimate exposure in the previous 30 days to an individual with poliomyelitis Participation in another interventional trial within 30 days before to the enrollment or simultaneous participation in another clinical study Infants whose families are planning to leave the area of the study site before the end of the study period Infants who is considered unsuitable for the clinical study by the investigator

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 8 Weeks

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group 1<br>Low dose (Stage2: Lot A) of investigational inactivated poliomyelitis vaccine based on Sabin strains (LBVC) | Biological: Inactivated Poliomyelitis Vaccine (Sabin strain)<br>* Investigational IPV based on Sabin strain (LBVC). Should be injected by intramuscular three injections in the anterolateral aspect of thigh at 6, 10 and 14 weeks of age.<br>|
| Experimental: Test group 2<br>Middle dose (Stage2: Lot B) of investigational inactivated poliomyelitis vaccine based on Sabin strains (LBVC) | Biological: Inactivated Poliomyelitis Vaccine (Sabin strain)<br>* Investigational IPV based on Sabin strain (LBVC). Should be injected by intramuscular three injections in the anterolateral aspect of thigh at 6, 10 and 14 weeks of age.<br>|
| Experimental: Test group 3<br>High dose (Stage2: Lot C) of investigational inactivated poliomyelitis vaccine based on Sabin strains (LBVC) | Biological: Inactivated Poliomyelitis Vaccine (Sabin strain)<br>* Investigational IPV based on Sabin strain (LBVC). Should be injected by intramuscular three injections in the anterolateral aspect of thigh at 6, 10 and 14 weeks of age.<br>|
| Active Comparator: Comparator<br>Cormmercialized inactivated poliomyelitis vaccine based on Sabin strains (Imovax Polio) | Biological: Inactivated Poliomyelitis Vaccine (Salk strain)<br>* Commercialized IPV based on Salk strain (Imovax Polio). Should be injected by intramuscular three injections in the anterolateral aspect of thigh at 6, 10 and 14 weeks of age.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage1: Seroconversion rate(%) | Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay | 4 weeks after 3rd vaccination | 
| Stage2: Seroconversion rate(%) | Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay | 4 weeks after 3rd vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage1: Seroconversion rate (%) | Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay | 4 weeks after 2nd vaccination | 
| Stage2: Seroprotection rate (%) | Proportion of subjects achieving seroprotection of each poliovirus serotype using microneutralization assay | 4 weeks after 3rd vaccination | 
| Stage1: GMTs (Geometric Mean Titers) | Comparison of GMTs and GMT ratios | 4 weeks after 2nd and 3rd vaccination | 
| Stage2: GMTs (Geometric Mean Titers) | Comparison of GMTs and GMT ratios | 4 weeks after 3rd vaccination |