Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan
Condition: Poliomyelitis; Polio
MeSH terms: Poliomyelitis
Intervention: IMOVAX POLIO®: Inactive Poliovirus Vaccine
Intervention description: 0.5 mL, Subcutaneous
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 4 Years
Maximum age: 6 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Poliomyelitis; Poliovirus; Polio; IMOVAX POLIO®; Inactivated polio vaccine

Summary:

      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.
    

Eligibility criteria:

        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.