ACTRN12624000445572进行中（未招募）2 期
Evaulating the effect on immune responses of administering COVID-19 and influenza vaccines in the same or opposite arms on the same day in healthy participants: the Cannon Study
niversity of Melbourne0 个研究点目标入组 56 人开始时间: 2024年4月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 56
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
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Healthy with no significant immunosuppressive illnesses. These include but are not limited to:
- •- cancer or treatment of cancer or organ transplantation
- •- treatment of auto-immune or inflammatory conditions such as inflammatory arthritis or inflammatory bowel disease
- •- use of corticosteroid, TNF inhibitor, interleukins, interferons, cyclosporine or other immunosuppressive medications
- •- significant renal or liver disease
- •Two or more prior doses of a COVID-19 vaccine, the last dose at least 4 months prior to recruitment
- •No previous significant adverse events to prior Influenza or COVID-19 vaccines, according to the criteria below. Severe grading indicates the event prevented daily activity, temperature >40.0°C or >10.0 cm in diameter for redness and swelling at the site of injection
- •- severe systemic events (fatigue, headache, fever, muscle or joint pain)
- •- severe local events (pain at injection site, redness and swelling
- •- any event requiring emergency department visit or hospitalisation
- •No prior anaphylaxis to any cause, including to prior Influenza or COVID-19 vaccines
- •No prior cardiac inflammatory condition (myocarditis, pericarditis), including to prior COVID-19 vaccine
- •Willing and available to have blood, saliva and nasal fluid samples taken per the schedule of events
- •Willing to be randomly assigned to receive Influenza and COVID-19 vaccines either in the same arm or opposite arms.
- •Willing to provide a signed and dated informed consent form.
排除标准
- •Prior COVID-19 infection or Influenza infection within 4 months of recruitment
- •Prior COVID-19 vaccination or Influenza vaccination within 4 months of recruitment
- •Pregnant or breastfeeding women and women planning to become pregnant
- •Unwilling to use reliable contraception around the timing of the vaccine (one month before and one month after)
- •Receiving medication that might reduce immune responses. These include but are not limited to:
- •- systemic corticosteroids
- •- interleukins
- •- interferons
- •- cyclosporine
- •- systemic chemotherapy
研究者
相似试验
招募中
1 期
Impact of the immune system on response to inactivated influenza vaccine (IIV) in allogeneic stem cell recipientsEUCTR2022-003041-35-BECHU de Liège100
尚未招募
不适用
The analysis of immune response on the effect of endocrine therapy in breast cancer patientsBreast cancerJPRN-UMIN000018621Juntendo University School of Medicine100
已完成
Unknown
Efficacy and safety evaluation of PPCE for immune enhancement in healthy adults.KCT0008678MnF Korea30
招募中
不适用
CIMAvax-EGF in different maintenance schemeson small cell lung cancerCarcinoma, Non-Small-Cell LungCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNSCLCRPCEC00000368Center of Molecular Immunology (CIM)42
已完成
不适用
Analysis of immune response behavior and agents by vaccination with new coronavirus infections in patients with hematopoietic malignanciesJPRN-UMIN000044850Hamamatsu University School of Medicine65