NL-OMON55932尚未招募不适用
beReady study: A study to identify potential healthy volunteers eligible for early phase vaccine trials in the context of pandemic preparedness - beReady study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Part 1 (e-mail questionnaire)
- •1. Healthy male or female subjects, >= 18 years of age;
- •2. Body mass index (BMI) >= 18.0 and < 32.0 kg/m2;
- •3. Willing to stay available and share availability for vaccine trial
- •participation;
- •4. Signed informed consent prior to any study- related procedures.
- •Part 2 (Phone screening):
- •1. Healthy male or female subjects, >= 18 years of age. Healthy status is
- •defined by absence of evidence of any active or chronic disease following a
- •detailed medical history;
- •2. Body mass index (BMI) >= 18.0 and < 32.0 kg/m2;
- •3. Willing to stay available and share availability for vaccine trial
- •participation;
- •4. Signed informed consent prior to any study- related procedures.
- •Part 3 (On site screening)
- •1. Healthy male or female subjects, >= 18 years of age. Healthy status is
- •defined by absence of evidence of any active or chronic disease following a
- •detailed medical and history;
- •Subjects 65 years of age and older: in the investigator*s clinical judgment,
- •participant must be either in good or stable health. Participant may have
- •underlying illnesses, as long as the symptoms and signs are medically
- •controlled and not considered to be comorbidities related to an increased risk
- •of severe COVID-19, except for smoking, which is allowed (see also exclusion
- •criterion 6).
- •2. Body mass index (BMI) >= 18.0 and < 32.0 kg/m2;
- •3. Willing to stay available and share availability for vaccine trial
- •participation;
- •4. Signed informed consent prior to any study- related procedures.
排除标准
- •Part 1 (e-mail questionnaire):
- •1. History of abuse of addictive substances (alcohol, illegal substances) or
- •current use of more than 21 units alcohol per week, drug abuse, or regular user
- •of sedatives, hypnotics, tranquillizers, or any other addictive agent;
- •2. History of anaphylaxis or other significant adverse event following
- •immunization.
- •Part 2 (Phone screening):
- •1. History of abuse of addictive substances (alcohol, illegal substances) or
- •current use of more than 21 units alcohol per week, drug abuse, or regular user
- •of sedatives, hypnotics, tranquillizers, or any other addictive agents;
- •2. History of anaphylaxis or other significant adverse event following
- •immunization;
- •3. Evidence of any active or chronic disease or condition that could interfere
- •with, the conduct of a study with a candidate vaccine, or that would pose an
- •unacceptable risk to the subject in the opinion of the investigator (following
- •a detailed medical history);
- •4. Prior receipt of immunoglobulins or vaccinations that is likely to impact
- •interpretation of study outcomes.
- •Part 3 (On site screening)
- •1. Evidence of any active or chronic disease or condition that could interfere
- •with, the conduct of a study with a candidate, or that would pose an
- •unacceptable risk to the subject in the opinion of the investigator (following
- •a detailed medical history);
- •2. History of anaphylaxis or other significant adverse event following
- •immunization;
- •3. Prior receipt of immunoglobulins or vaccinations that is likely to impact
- •interpretation of study outcomes;
- •4. Participation in an investigational drug study;
- •5. History of abuse of addictive substances (alcohol, illegal substances) or
- •current use of more than 21 units alcohol per week, drug abuse, or regular user
- •of sedatives, hypnotics, tranquillizers, or any other addictive agent;
- •6. Heavy smokers who normally consume more than 5 cigarettes a day. Smokers
- •will be defined as any subject who reports tobacco use;
- •7. Any confirmed significant allergic reactions (urticaria or anaphylaxis)
- •against any drug, or multiple drug allergies;
- •8. History of bleeding disorder (e.g. factor deficiency, coagulopathy, or
- •platelet disorder requiring special precautions), significant bleeding or
- •bruising following intramuscular injections or vena punctures;
- •9. Loss or donation of blood over 500 mL within three months (males) or four
- •months (females) prior to enrollment in the healthy volunteer pool or intention
- •to donate blood or blood products during the stand-by participation in a
- •vaccine trial;
- •10. Any known factor, condition, or disease that might interfere with treatment
- •compliance, study conduct or interpretation of the results such as drug or
- •alcohol dependence or psychiatric disease.
- •Note that not for all future vaccine trials all the above-described exclusion
- •criteria are required. Then, only a subset of exclusion will be taken. No
- •additional assessments than required for the above-described exclusion criteria
- •will be performed.
研究者
相似试验
招募中
Unknown
Cohort study to discover unmet health care needs of gastric cancer survivorsKCT0008810ational Cancer Center1,684
尚未招募
Unknown
Identification of clinically relevant biomarkers for early detection of progression analysis of NAFLD to NASHCTRI/2023/12/060718Strand Life Sciences Private Limited
尚未招募
不适用
Factors influencing the preparedness of novice nurses to care for patients in Intensive CareCTRI/2022/01/039356Suveksha Giri
尚未招募
2 期
Optimal dose of centchroman in management of cyclical mastalgiaCTRI/2024/08/072215ttar Pradesh University of Medical Sciences
已完成
不适用
A non-therapeutic feasibility study to evaluate the kinetics and test-retest repeatability and reproducibility of the radioligand [11C]-UCB-J for imaging synaptic density in healthy subjects and mild-to-moderate Alzheimer*s Disease subjectsdementiaAlzheimerAlzheimer's DiseaseNL-OMON48549Rodin Therapeutics, Inc.20