EUCTR2015-005187-42-Outside-EU/EEAActive, not recruitingNot Applicable
Immunogenicity and Safety of the SP059 Given Subcutaneously as a Three-Dose Primary and Booster Vaccination in Infants in Japan
Sanofi Aventis K.K.0 sites74 target enrollmentStarted: November 19, 2015Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 74
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1) Aged 3 to 68 months inclusive (recommended 3 to 8 months) on the day of inclusion
- •2) Informed consent form signed by the parent(s) or other legal representative
- •3) 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: 74
- •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
- •1) Fever = 37.5°C (axillary temperature) on the day of inclusion
- •2) Any serious disease whether acute or chronic
- •3) History of poliomyelitis infection
- •4) History of a life threatening reaction to a vaccine containing the same substances of the study vaccine
- •5) History of anaphylaxis or allergy to any of the study vaccine components
- •6) Previous vaccination against the poliomyelitis diseases infection with a trial vaccine or another vaccine
- •7) Congenital or current/ previous acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- •8) Participation in another clinical trial preceding the trial inclusion
- •9) Planned participation in another clinical trial during the present trial period
- •10) Blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins).
- •11) Any vaccination with live vaccines within the past 27 days preceding the first trial vaccination.
- •12) Any vaccination with inactivated vaccines within the past 6 days preceding the first trial vaccination.
- •13) Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or human immunodeficiency virus infection
- •14) Subject ineligible according to the investigator's clinical judgment.
Investigators
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