ACTRN12623000650695招募中Unknown
Evaluation of the psychoneuroimmunological state of healthy humans following intramuscular injection of the influenza (FluQuadriTM) vaccine, a two-way crossover double-blinded placebo-controlled trial
Australian Government, Department of Defence (Defence Science and Technology Group, DMTC)0 个研究点目标入组 40 人开始时间: 2023年6月15日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 40
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 40 Years（—）
- 性别
- All
入选标准
- •Healthy participants aged between 18 and 40 years.
- •-No history of seizures, head injury or head physiognomy (head shape) that would preclude EEG cap placement.
- •-Able to provide written and informed consent in English.
- •-Are willing to receive the influenza vaccination during the trial.
- •-Body weight greater than 50 kg (minimum blood donation weight set by the Red Cross Blood Bank); BMI index between 18.5-29.9.
- •-Must be non-smokers or have ceased smoking for more than 3 months.
排除标准
- •-Have been diagnosed with neurological conditions or neurodegenerative diseases, such as depressive, anxiety or post-traumatic stress disorder, sleep conditions, or Attention Deficit Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder.
- •-2 week exclusion for vaccination of any type, if infected with Covid or influenza during the testing period, adjustments will be made to the testing protocol to allow for recovery from infection.
- •-Have received an immunisation for the influenza strains contained within the current year’s influenza vaccine formulation.
- •-Participants have had a positive test response for active influenza infection during the same season.
- •-Have medical conditions which preclude them from having an influenza vaccination.
- •-Have a history of anaphylaxis to eggs or past vaccinations.
- •-Have had a ever had a severe allergic reaction to any of the ingredients listed in the FluQuadriTM vaccine as indicated on the Consumer Medicine Information summary (Sodium chloride, dibasic sodium phosphate, monobasic sodium phosphate, water for injection, and traces of ovalbumin (egg protein), octoxinol-9 and formaldehyde).
- •-Be pregnant or actively trying to conceive.
- •-Have an ongoing chronic inflammatory condition.
- •-Have a phobia with needles.
- •-Have used any prescription, or over-the-counter medication (other than paracetamol and oral contraceptives) in the 24 hours leading up to the study days, including the use of illicit drugs and/or alcohol.
- •-Are a regular user of marijuana. Must be able to withstand using for duration of trial.
- •-Have had any caffeine in the 12 hours leading up to the study days.
研究者
相似试验
撤回
不适用
A study of neuropsychological functioning in patients undergoing aortic valve replacement: the transcatheter and the surgical approachcognitive dysfunctioningneuropsychological dysfunctioning1004697310009841NL-OMON38055Academisch Medisch Centrum120
尚未招募
不适用
Examination and evaluation of neuropsychological processes and behavioral characteristics of migraineurs in response to an indirect migraine trigger confrontation.G43MigraineDRKS00032084niversitätsklinikum Würzburg Neurologische Klinik60
进行中（未招募）
不适用
Psychometric and neurological evaluation of mental representations of daily activities in dementia patientsF00G30.1F02.0F06.7Alzheimer disease with late onsetDementia in Pick diseaseMild cognitive disorderDementia in Alzheimer diseaseDRKS00023340Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE) e.V., Greifswald4
已完成
不适用
To investigate the benefit of cycling and flat-ground walking in people with Chronic Obstructive Pulmonary Disease (COPD)chronic obstructive pulmonary disease (COPD)Respiratory - Chronic obstructive pulmonary diseaseACTRN12608000126314The University of Sydney40
已完成
不适用
Psycological/physiological response evaluation by application of aroma componentsHealthy adultJPRN-UMIN000029702Industrial Research Institute of Shizuoka Prefecture18