PACTR201208000404131已完成1 期
A Phase 1/2b double blind randomised controlled trial of the efficacy, safety and immunogenicity of heterologous prime-boost immunisation with the candidate malaria vaccines ChAd63 ME-TRAP and MVA ME-TRAP in 5-17 month old Burkinabe infants and children
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 730
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 5 Month(s) 至 17 Month(s)（—）
- 性别
- All
入选标准
- •1.Healthy infant/child aged 5-17 months at the time of first study vaccination
- •2.Informed consent of parent/guardian
- •3.Infant/child and parent/guardian resident in the study area villages and anticipated to be available for vaccination and follow-up
排除标准
- •1. Clinically significant skin disorder (psoriasis, contact dermatitis etc.), immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.
- •2. Weight-for-age Z score of less than ¿3 or other clinical signs of malnutrition
- •3. History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunisation
- •4. History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, beta-propiolactone.
- •5. Haemoglobin less than 8.0 g/dL, where judged to be clinically significant in the opinion of the investigator
- •6. Serum Creatinine concentration greater than 70 µmol/L, where judged to be clinically significant in the opinion of the investigator
- •7. Serum ALT concentration greater than 45 U/L, where judged to be clinically significant in the opinion of the investigator
- •8. Blood transfusion within one month of enrolment
- •9. Previous vaccination with experimental malaria vaccines.
- •10. Administration of any other vaccine or immunoglobulin less than one week before vaccination with any study vaccine.
- •11. Current participation in another clinical trial, or within 12 weeks of this study.
- •12. Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial or result in incomplete or poor quality data
- •13. Known maternal HIV infection (No testing will be done by the study team)
- •14. Immunosuppressive therapy (steroids, immune modulators or immune suppressors) within 3 months prior recruitment. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5mg/kg/day. Inhaled and topical steroids are allowed.)
研究者
相似试验
已完成
2 期
A Phase 2 Double -blind, Randomized, Controlled Trial to Assess the Safety and Immunogenicity of 10 mcg HXP-GPOVac Vaccine in Healthy Volunteershealthy adultsphase 2, covid vaccine, clinical trial, HXP-GPOVacTCTR20220819003Government Pharmaceutical Organization, Thailand300
进行中（未招募）
1 期
A placebo-controlled clinical trial to evaluatethe efficacy and safety of two Aramchol doses in patients with Non-Alcoholic Steatohepatitis (NASH).EUCTR2014-003107-29-ITGALMED PHARMACEUTICALS LTD.240
进行中（未招募）
不适用
A placebo-controlled clinical trial to evaluate the efficacy and safety of two Aramchol doses in patients with Non-Alcoholic- Steatohepatitis (NASH).on-alcoholic Steatohepatitis in patients with two additional features of metabolic syndrome -overweight or obesity and Diabetes Mellitus type II or pre-diabetes.MedDRA version: 18.0Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2014-003107-29-ROGALMED Pharmaceuticals LTD.240
进行中（未招募）
1 期
A placebo-controlled clinical trial to evaluate the efficacy and safety of two Aramchol doses in patients with Non-Alcoholic- Steatohepatitis (NASH).EUCTR2014-003107-29-LTGALMED Pharmaceuticals LTD.240
进行中（未招募）
1 期
A Phase IIb, double blind, randomized controlled clinical trial to evaluate the efficacy and safety of two Aramchol doses versus placebo in patients with Non-Alcoholic- Steatohepatitis (NASH).EUCTR2014-003107-29-DEGALMED Pharmaceuticals LTD.240