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 个研究点目标入组 74 人开始时间: 2015年11月19日最近更新: 2015年12月7日

适应症

试验速览

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•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

•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.

发起方

Sanofi Aventis K.K.