RPCEC00000058已完成2 期
A phase II, double-blind, randomized, controlled study to evaluate the reactogenicity and immunogenicity of the Cuban vaccine against tetanus and diphtheria, VA-DIFTET, and the control vaccine D.T. VAX in children.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Double Blind. Control group: Active. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 5 years 至 7 years（—）
- 性别
- All
入选标准
- •1-A male or female between, and including, 5 and 7 years of age at the time of the vaccination. 2-Written informed consent obtained from the parents or guardians. 3-Free from obvious health problems as established by medical history and clinical examination before entering into the study.
排除标准
- •1-Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs prior to the vaccination. Inhaled and topical steroids are allowed. 2-Administration of a vaccine not foreseen by the study protocol during the period starting one month before the application of the study vaccine and ending one month after that application. 3-Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. 4-History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. 5-History of any neurological disorders or seizures. 6-Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. 7-Use of any investigational or non-registered drug other than the study vaccine within 30 days preceding the single dose of the study vaccine, or planned use during the study period. 8-Axillary temperature of >=37.5°C before vaccination.
研究者
相似试验
已完成
2 期
A phase II study of the Cuban adult formulation tetanus and diphtheria vaccine.Tetanustetanus and diphtheriaClostridium InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsCorynebacterium InfectionsActinomycetales InfectionsDiphtheriaRPCEC00000059Finlay Institute225
进行中（未招募）
不适用
A phase II, randomized, double-blind, controlled study to evaluate the immune responses, safety and clinical efficacy of three doses of Neovacs’ TNF-Kinoid in adult patients with rheumatoid arthritis who have relapsed despite anti-TNFa biological therapyMedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid arthritisEUCTR2009-012041-35-BEeovacs SA48
进行中（未招募）
不适用
A phase II, randomized, double-blind, controlled study to evaluate the immune responses, safety and clinical efficacy of three doses of Neovacs’ TNF-Kinoid in adult patients with rheumatoid arthritis who have relapsed despite anti-TNFa biological therapyMedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid arthritisEUCTR2009-012041-35-BGeovacs SA48
进行中（未招募）
不适用
A clinical study to evaluate the efficacy to stop the bleeding and safety of TT-173 applied in the donor site of patients undergoing skin graft.EUCTR2013-002784-25-ESThrombotargets Europe
进行中（未招募）
不适用
Study of safety, immunogenicity and efficacy of a candidate malaria vaccine in Tanzanian infants.EUCTR2015-001539-19-Outside-EU/EEAGlaxoSmithKline Biologicals340