Study of SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan

Study Overview
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Brief Summary
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The aim of the study is to assess the immunogenicity and safety of SP059 as a three-dose primary and booster vaccination in Japanese infants aged 3 through 68 months. Primary objective: To assess that the seroprotection rates against polio types 1, 2 and 3 are over 90% approximately one month following the three dose primary vaccination series with inactivated polio vaccine (IPV). Secondary objective: To describe the immunogenicity (in terms of seroprotection / seroconversion vaccine response rates and Geometric Mean Titers) of IPV before and after the primary vaccination and before and after the booster vaccination. To describe the safety after each dose of IPV.

Detailed Description
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Study participants will receive three doses of inactivated polio vaccine (IPV) (at each visit and given 3-8 weeks apart) as a three-dose primary vaccination starting at 3-68 months of age and followed by a single dose of IPV as a booster vaccination 6-18 months after completion of the three-dose primary vaccination. Subjects will be observed by the Investigator or sub-Investigator for 30 minutes following the vaccine injection. The duration of each participant's participation in the trial will be approximately 1 year.

Official Title
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Immunogenicity and Safety of the SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan

Conditions
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Poliomyelitis, Polio

Intervention / Treatment
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* Biological: Inactive Poliovirus Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 3 to 68 months inclusive (recommended 3 to 8 months) on the day of inclusion Informed consent form signed by the parent(s) or other legal representative Able to attend all scheduled visits and to comply with all trial procedures Exclusion Criteria: Fever ≥ 37.5°C (axillary temperature) on the day of inclusion Any serious disease whether acute or chronic History of poliomyelitis infection History of a life threatening reaction to a vaccine containing the same substances of the study vaccine History of anaphylaxis or allergy to any of the study vaccine components Previous vaccination against the poliomyelitis diseases infection with a trial vaccine or another vaccine Congenital or current/ previous acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy Participation in another clinical trial preceding the trial inclusion Planned participation in another clinical trial during the present trial period Blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins). Any vaccination with live vaccines within the past 27 days preceding the first trial vaccination. Any vaccination with inactivated vaccines within the past 6 days preceding the first trial vaccination. Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or human immunodeficiency virus infection Subject ineligible according to the investigator's clinical judgment.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 68 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br> | Biological: Inactive Poliovirus Vaccine<br>* 0.5 mL, Subcutaneous<br>* Other names: SP059;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A description of the anti-Polio 1, 2 and 3 antibody titers post-vaccination | Anti-Polio 1, 2 and 3 antibody titers will be determined by the Seroneutralization assay. | 1 month post-vaccination 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity (in terms of seroprotection and Geometric Mean Titers) of inactivated polio vaccine (IPV) before and after the primary vaccination and before and after the booster vaccination. |  | Day 0 and 1 month post-vaccination | 
| Description of the safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with IPV | Solicited injection site: Tenderness (3 to 23 months); Pain (2 to 11 years), Redness, and Swelling. Solicited Systemic reaction: 3 to 23 month olds: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability: 2 to 11 year olds: Fever (Temperature), Headache, Malaise, and Myalgia. | Day 0 up to 12 months post-vaccination | 
| Immunogenicity (in terms of anti-Polio 1, 2, and 3 titers ≥ 8 [1/dilution], individual antibodies' titers and Geometric Mean Titers) of inactivated polio vaccine (IPV) after the booster vaccination. | Anti-Polio 1, 2 and 3 antibody titers will be determined by the Seroneutralization assay. | 1 month post-booster vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Poliomyelitis, Inactivated polio vaccine, Polio, Poliovirus