EUCTR2015-005188-17-Outside-EU/EEA进行中（未招募）不适用
Immunogenicity and Safety of different sequential schedules of Inactivated Poliomyelitis Vaccine (IMOVAX Polio®) followed by Oral Poliomyelitis Vaccine in Healthy Infants in China versus Oral Poliomyelitis Vaccine Alone
Sanofi Pasteur SA0 个研究点目标入组 456 人开始时间: 2015年11月19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
- 456
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
- •1) Aged =2 months and less than 3 months on the day of first study vaccine administration
- •2) Born at full term of pregnancy (=37 weeks) and with a birth weight =2.5 kg
- •3) Informed consent form has been signed and dated by the parent or other legally acceptable representative
- •4) Subject and parent/legally acceptable representative are 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: 456
- •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
- •1) Participation in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- •2) Receipt or planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination (except Diphtheria, Tetanus, acellular Pertussis vaccine [DTaP], Haemophilus Influenzae Type b [Hib] vaccine, bacille Calmette-Guerin vaccine [BCG] and Hepatitis B given at least 7 days before and after study vaccination)Previous vaccination against poliomyelitis with either the trial vaccine or another vaccine
- •3) Receipt of immune globulins, blood or blood-derived products since birth
- •4) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
- •5) Congenital or acquired immunodeficiency in close contacts to the subjects
- •6) History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
- •7) At high risk for human immunodeficiency virus (HIV) infection during the trial
- •8) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
- •9) Laboratory-confirmed or otherwise known thrombocytopenia, contraindicating intramuscular vaccination
- •10) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
- •11) Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- •12) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- •13) Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature =37.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
- •14) Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
- •15) Any other contraindication as listed in the study vaccines' leaflets.
研究者
相似试验
招募中
不适用
To study the efficacy and safety of early (at birth) versus late (34 weeks gestation) BCG vaccination in preterm babies born between 31-33 weeks gestatioCTRI/2013/09/004019niversity College of Medical Sciences and Guru Tegh Bahadur Hospital180
已完成
不适用
Immunogenicity and Safety Outcome of Homologous and Heterologous Prime-boost of Inactivated Vaccine and Replication-defective Viral Vectors Vaccine Against SARS-CoV2 among Hemodialysis Patients: An Observational Prospective Cohort TrialTCTR20220516002Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand130
已完成
不适用
Safety, efficacy and immunogenicity of concomitant molecular target drug or cytokine therapy and autologous tumor lysate-pulsed dendritic cell therapy in patients with advanced renal cell carcinomaRenal cell carcinomaJPRN-UMIN000014703The University of Tokyo Hospital15
已完成
不适用
Safety, efficacy and immunogenicity of concomitant interferon alpha and autologous tumor lysate-pulsed dendritic cell therapy in patients with advanced renal cell carcinomaRenal cell carcinomaJPRN-UMIN000006646The University of Tokyo Hospital15
进行中（未招募）
1 期
The 6-in-1 Vaccine StudyEUCTR2018-003451-38-GBClinical Trials and Research Governance (CTRG)240