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

• 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. [ Time Frame: Day 0 and 1 month post-vaccination ] [ Designated as safety issue: No ]
• Description of the safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with IPV [ Time Frame: Day 0 up to 12 months post-vaccination ] [ Designated as safety issue: No ]
  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.
• 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. [ Time Frame: 1 month post-booster vaccination ] [ Designated as safety issue: No ]
  Anti-Polio 1, 2 and 3 antibody titers will be determined by the Seroneutralization assay.

• 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. [ Time Frame: Day 0 and 1 month post-vaccination ] [ Designated as safety issue: No ]
• Description of the safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with IPV [ Time Frame: Day 0 up to 12 months post-vaccination ] [ Designated as safety issue: No ]
  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.

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.

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.

• Poliomyelitis
• Polio

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.