EUCTR2015-003279-31-Outside-EU/EEA进行中（未招募）不适用
Immunogenicity and Safety of IMOVAX POLIO® Subcutaneous as a Booster Given in Pre-school Age Children in Japan (IPV46)
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
- Sanofi K.K.
- 入组人数
- 60
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 4 to 6 years inclusive on the day of inclusion
- •- Subjects who received 4 times an IPV-containing vaccine (DTaP-IPV or IPV) during first (3 doses) and second year of life (one dose)
- •- 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
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •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
- •- Fever = 37.5°C (axillary temperature) on the day of inclusion
- •- Any serious disease whether acute or chronic
- •- Past or current medical history of Guillain-Barre syndrome, acute thrombocytopenic purpura or encephalopathy
- •- History of poliomyelitis infection
- •- History of a life threatening reaction to a vaccine containing the same substances of the study vaccine (Inactivated poliovirus types 1, 2, and 3, 2-Phenoxyethanol, Formaldehyde, M199 Hanks medium)
- •- History of anaphylaxis or allergy to any of the study vaccine components ((Inactivated poliovirus types 1, 2, and 3, 2-Phenoxyethanol, Formaldehyde, M199 Hanks medium)
- •- Congenital or current/ previous acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy*
- •- Participation in another clinical trial within 6 months before the trial inclusion**
- •- Planned participation in another clinical trial during the present trial period
- •- Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw
- •- Received antipyretics/analgesics/NSAIDs (considered as category 1) within 4 hours prior to vaccination
- •- 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 HIV infection
- •- Subject ineligible according to the Investigator’s clinical judgment
- •* Systemic corticosteroids therapy (prednisone or equivalent at = 0.5 mg/kg/day) for more than 2 consecutive weeks within the past 2 months.
- •** Participation in another clinical trial investigating a vaccine, a drug, a medical device or a medical procedure.
研究者
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