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

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 60

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 (Inactivated poliovirus types 1, 2, and 3, 2-Phenoxyethanol, Formaldehyde, M199 Hanks medium)
- History of anaphylaxis or allergy to any of the study vaccine components ((Inactivated poliovirus types 1, 2, and 3, 2-Phenoxyethanol, Formaldehyde, M199 Hanks medium)
- 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/NSAIDs (considered as category 1) 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 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 HIV infection
- Subject ineligible according to the Investigator’s clinical judgment

* Systemic corticosteroids therapy (prednisone or equivalent at = 0.5 mg/kg/day) for more than 2 consecutive weeks within the past 2 months.
** Participation in another clinical trial investigating a vaccine, a drug, a medical device or a medical procedure.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the booster vaccine response rate against poliovirus types 1, 2 and 3 one month following the vaccination dose with SP059 as a second booster.;Secondary Objective: Immunogenicity<br>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 of titers (GMT) at pre- and post-booster time points and geometric mean<br>of individual titer ratio (GMTR)<br><br>Safety<br>To describe the safety after dosing of SP059 as a second booster.;Primary end point(s): Percentage of subjects developing at least a four-fold rise in their antibody titers between the pre-booster (Visit 1) and one month (4-6 weeks [28-42 days]) after the dose of IPV (Visit 2).;Timepoint(s) of evaluation of this end point: Pre-booster (Visit 1) and 1 post-IPV dose (Visit 2)

Secondary Outcome Measures

Name	Time	Method

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