RPCEC00000055
已完成
1 期
A phase I/II, double-blind, randomized, controlled study to evaluate the safety, reactogenicity and immunogenicity of a single dose of the Cuban Salmonella Typhi Vi polysaccharide vaccine – vax-TyVi –, and the control vaccines – Typhim-Vi and vax-TET – , intramuscularly applied to children and teenagers.
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- typhoid fever
- 发起方
- Finlay Institute
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\-A male or female between, and including, 9 and 13 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. 4\-If the subject is a female of childbearing potential; she must be abstinent or have to use adequate contraceptive precautions during the study. Negative pregnancy tests have to be obtained before vaccination.
排除标准
- •1\-Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, metabolic or renal functional abnormality, as determined by physical examination. 2\- 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. 3\-Use of other typhoid vaccine within 2 years preceding the study. 4\-Planned administration / 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. 5\-Any hematological disease. 6\-Administration of immunoglobulins and/or any blood products within the three months preceding the single dose of the candidate vaccine or planned administration during the study period. 7\-Possibility of administration of any blood by\-products during the study period. 8\-Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. 9\-A family history of congenital immunodeficiency. 10\-History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. 11\-History of any neurological disorders or seizures. 12\-Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. 13\-Use of any investigational or non\-registered drug other than the study vaccine within 30 days preceding the single dose of study vaccine, or planned use during the study period. 14\-Axillary temperature of \>\=37\.5°C before vaccination. 15\-Administration of immunosuppressants, other immune\-modifying drugs or radiotherapy during the study period. Inhaled and topical steroids are allowed. 16\-Pregnancy. 17\-Difficulties to obtain a blood sample of a subject.
结局指标
主要结局
未指定
相似试验
进行中（未招募）
不适用
Examine safety & immune responses of GSK 257049 vaccine when administered to infants living in a malaria-endemic regioHealthy volunteers (Primary immunization against Plasmodium falciparum malaria).Therapeutic area: Diseases [C] - Parasitic Diseases [C03]EUCTR2015-001538-25-Outside-EU/EEAGlaxoSmithKline Biologicals214
进行中（未招募）
不适用
Safety and immunogenicity study of GlaxoSmithKline (GSK) Biologicals’ pneumococcal vaccine 2830930A when given as 1 dose to healthy toddlers aged 12-23 months.EUCTR2011-002225-22-DEGlaxoSmithKline Biologicals
已完成
不适用
Phase II multi-centre study to evaluate efficacy, safety, and immunogenicity of GMZ2 candidate malaria vaccine in children aged 12 to 60 monthsMalariaPaediatricsPACTR2010060002033537Statens Serum Intitute1,840
进行中（未招募）
不适用
A phase I/II, randomized, single blind, controlled study in adults aged 18-60 years to evaluate the immunogenicity, safety and reactogenicity of an adjuvanted influenza vaccine candidate (GSK 2115160A). - FLU-D-QIV-001 PRIImmunization of healthy adults aged 18 to 60 years against influenzaEUCTR2008-001303-34-CZGlaxoSmithKline Biologicals
已完成
1 期
Phase I-II study of live oral cholera vaccine 638 in healthy adult volunteers in Cuba.Cholera diseaseCholera/ prevention & controlHealthy VolunteersVibrio InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsWaterborne DiseasesEnvironmental IllnessRPCEC00000053Finlay Institute48