Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan

Study Overview
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Brief Summary
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The aim of the study is to assess the immunogenicity of SP059 (IMOVAX POLIO®: Inactive Poliovirus Vaccine) vaccine against poliovirus and safety after fifth dose. Primary Objective: To investigate the booster vaccine response rate against poliovirus types 1, 2 and 3 one month following the vaccination dose with SP059 as 2nd booster Secondary Objectives: To investigate seroprotection rates (percentage of subjects presenting poliovirus neutralizing antibody titers above 1:8 (1/dil.) at pre- and post-booster time points, Geometric mean titers (GMT) at pre- and post-booster time points and geometric mean of individual titer ratio (GMTR). To investigate the safety after dosing of SP059 as 2nd booster.

Detailed Description
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Participants will receive one dose of SP059 (at Visit 1) as a booster vaccination at an age from 4 to 6 years. They will be assessed for immunogenicity at baseline (pre-vaccination) and at 4-6 weeks post- vaccination. Safety data including serious adverse events (SAEs) after vaccination will be collected during the study period.

Official Title
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Immunogenicity and Safety of IMOVAX POLIO® Subcutaneous as a Booster Given in Pre-school Age Children in Japan

Conditions
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Poliomyelitis, Polio

Intervention / Treatment
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* Biological: IMOVAX POLIO®: Inactive Poliovirus Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 4 to 6 years inclusive on the day of inclusion Subjects who received 4 times an IPV-containing vaccine (DTaP-IPV or IPV) during first (3 doses) and second year of life (one dose) 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 Past or current medical history of Guillain-Barre syndrome, acute thrombocytopenic purpura or encephalopathy 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 Congenital or current/previous acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy Participation in another clinical trial within 6 months before the trial inclusion Planned participation in another clinical trial during the present trial period Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw Received antipyretics/analgesics/Non-steroidal anti-inflammatory drugs (considered as a single category) within 4 hours prior to vaccination 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 trial vaccination Any vaccination with inactivated vaccines within the past 6 days preceding the trial vaccination Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection Subject ineligible according to the Investigator's clinical judgment.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 Years

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Participants will receive one booster dose of SP059 (IMOVAX POLIO®) | Biological: IMOVAX POLIO®: Inactive Poliovirus Vaccine<br>* 0.5 mL, Subcutaneous<br>* Other names: IMOVAX POLIO®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO® | A booster response was defined as a 4-fold increase from pre-booster to post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay. | Day 28 post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO® | Anti-polio virus antibodies were assessed by virus neutralization assay. | Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination | 
| Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO® | Seroprotection was defined as a titer of ≥ 8 (1/dil) pre-booster or post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay | Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination | 
| Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vaccination With IMOVAX POLIO® | Anti-polio virus anti-bodies were assessed by virus neutralization assay. The geometric mean titer ratio is the post-booster to pre-booster geometric mean ratio values. | Day 28 post-booster vaccination | 
| Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO® | Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia. Grade 3 was defined as incapacitating, unable to perform usual activities for Pain; diameter ≥ 50 mm for Erythema and Swelling; Temperature ≥ 39.0°C for Fever; and significant, prevents daily activity for Headache, Malaise, and Myalgia. | Day 0 up to Day 7 post-vaccination | 

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