EUCTR2015-005183-42-Outside-EU/EEA进行中（未招募）不适用
Immunogenicity and Safety of Fractional Doses of Sanofi Pasteur’s Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) Administered Intradermally versus Full Doses of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) Administered Intramuscularly in Healthy Infants in The Philippines
Sanofi Pasteur SA0 个研究点目标入组 236 人开始时间: 2015年11月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 236
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria to be checked at the screening visit (SC):
- •- Aged 0 to 7 days on the day of screening
- •- Born at full term of pregnancy (=37 weeks) and with a birth weight =2.5 kg
- •- Informed consent form signed by the parent(s) or other legally acceptable representative
- •- Subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures
- •- Inclusion Criteria to be checked at the randomization visit (V01):
- •- Aged 42 to 50 days on the day of inclusion
- •- Subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 236
- •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
排除标准
- •Exclusion Criteria to be checked at the screening visit (SC):
- •- Planned participation in another clinical trial during the present trial period
- •- Illness that could interfere with trial conduct or completion, in the opinion of the investigator
- •- Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response
- •- History of seizures
- •- Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity
- •- Thrombocytopenia or bleeding disorder contraindicating IM injection
- •- Exclusion Criteria to be checked at the randomization visit (V01):
- •- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- •- Planned participation in another clinical trial during the present trial period
- •- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- •- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
- •- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
- •- Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response
- •- Receipt or planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination (except BCG, DTP-Hib or Hepatitis B vaccines, which can not be given within 10 days before or after any study vaccination)
- •- History of seizures
- •- Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity
- •- History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
- •- Previous vaccination against the poliomyelitis disease with either the trial vaccine or another vaccine
- •- Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) injection
- •- Febrile illness (temperature =38°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
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