Study to Evaluate Eupolio(IPV)'s Safety, Long-term Protective Effect and Boosting Effect of One Booster Dose in the Three Primary Vaccination Plus Boosting Schedule, and Protective Effect in the Schedule With Bivalent OPV in Infants

Study Overview
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Brief Summary
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Eupolio is inactivated poliovirus vaccine (IPV). Major purpose of this study is to evaluate safety of Eupolio in 2,000 infants. In addition to the safety, long-term protection after completion of the three primary vaccinations and extent of protective level after a single boosting dose of Eupolio will be evaluated. As IPV plus bOPV vaccination schedule (3 doses of bOPV plus 2 doses of IPV in infant-toddle vaccination schedule) has been implemented in some countries, this study will also evaluate Eupolio's safety and protective effect in that schedule.

Official Title
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A Multicenter, Open-label, Interventional Phase 3b Study to Evaluate the Safety, One-year Antibody Persistence, Priming Immune Responses of Three Doses of Eupolio Inj. (Inactivated Polio Vaccine (Sabin Strains)) and Immunogenicity of Two Doses of Eupolio Inj. Following Three Doses of bOPV in Infants

Conditions
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Poliomyelitis, Vaccine Reaction

Intervention / Treatment
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* Biological: Eupolio


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants in stable health Male or female 6 to 8 weeks of age Signed informed consent by the infant's parent(s) or legally acceptable representative(s) Exclusion Criteria: Known or suspected poliomyelitis Known or suspected febrile(symptom of a fever), or chronic illnesses Fever ≥ 38.0℃/100.4℉ within 3 days prior to study registration or intake of drug preventing fever Known or suspected immune disorders (abnormal activity in protective system in human body) or received immunosuppressive therapy (treatment for weaken protective system in human body) Previous use of blood or blood-derived products Previous use of polio vaccines Seizures (temporary abnormalities in muscle tone or movements due to abnormal activity in the brain) Bleeding disorders Household contact or intimate exposure with a confirmed case of polio Any history of allergy (hypersensitivity) to the components of the polio vaccine Participation in another interventional clinical trial simultaneously or within 30 days

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Safety group<br>Three doses of Eupolio will be administered at 6, 10 and 14 weeks of age. Only safety will be evaluated for this arm. | Biological: Eupolio<br>* Inactivated Polio vaccine (Sabin strains)<br>|
| Experimental: Immunogenicity group 1 (4 Eupolio including 1 boosting dose)<br>Three doses of Eupolio will be administered at 6, 10 and 14 weeks of age, and additional single dose of Eupolio will be administered one year after the three primary vaccinations. | Biological: Eupolio<br>* Inactivated Polio vaccine (Sabin strains)<br>|
| Experimental: Immunogenicity group 2 (3bOPV+2 Eupolio)<br>bOPV will be administered at 6, 10 and 14 weeks of age, and Eupolio will be administered at 14 and 40 weeks of age. | Biological: Eupolio<br>* Inactivated Polio vaccine (Sabin strains)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate reaction | Any side effects that occur within 30 minutes after the vaccination | 30 minutes after each vaccination | 
| Solicited adverse event | Expected local or systemic side effects after vaccination | 7 days after each vaccination | 
| Unsolicited adverse event | All unwanted or bad events after vaccination other than solicited adverse event | 28 days after each vaccinations | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprotection rate | Proportion of infants who have more than 8 protective antibody titers | 4 weeks after the third vaccination, 52 weeks after the third vaccination and 7 days after the boosting vaccination in the 4 Eupolio group/ 4 weeks after the first and second vaccination in the 3bOPV+2Eupolio group | 
| Geometric mean titers of neutralizing antibody against polio antigens | Geometric mean titers and log2 titers for protective antibody against poliovirus type 1, 2, and 3 | 4 weeks after the third vaccination, 52 weeks after the third vaccination and 7 days after the boosting vaccination in the 4 Eupolio group / 4 weeks after the first and second vaccination in the 3bOPV+2Eupolio group | 
| Priming response | Proportion of infants who have more than 8 protective antibody titers after boosting dose, depending on protective state before boosting dose. | 7 days after the boosting vaccination in the 4 Eupolio group | 
| Seroconversion rate | Proportion of infants who have more than 8 protective antibody titers after three primary vaccinations, depending on protective state before vaccination. | 4 weeks after the third vaccination in the 4 Eupolio group / 4 weeks after the first and second vaccination in the 3bOPV+2Eupolio group |