EUCTR2015-005184-16-Outside-EU/EEA进行中（未招募）不适用
Immunogenicity and Safety of Fractional Booster Dose of sanofi pasteur’s Inactivated Poliomyelitis Vaccine (IMOVAX Polio) Administered Intradermally versus Full Booster Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio) Administered Intramuscularly at 15 to 18 Months of Age in Healthy Toddlers in The Philippines
Sanofi Pasteur SA0 个研究点目标入组 225 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
- 225
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
- •- Aged 15 to 18 months on the day of inclusion
- •- 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
- •- Child having completed all visits of the IPV25 study (NCT00604058), including the three-dose primary vaccination series with the study vaccine (IMOVAX Polio), using the route of administration as designated by randomization.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 225
- •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
- •- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination
- •- Planned participation in another clinical trial during the present trial period
- •- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or 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 of any vaccine in the 4 weeks preceding the trial vaccination
- •- Planned receipt of any vaccine during the present trial period
- •- Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity
- •- History of seizures
- •- History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
- •- Previous fourth dose 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 IM injection
- •- Febrile illness (temperature =38.0 °C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment.
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