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临床试验/CTIS2024-513558-30-00
CTIS2024-513558-30-00进行中(未招募)1 期

Optimizing the time of day of influenza vaccine administration in adults aged 60-85 years: A randomized controlled trial - IIV-654

Rijksinstituut voor Volksgezondheid en Milieu (RIVM)0 个研究点目标入组 440 人开始时间: 2024年4月24日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
440

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
18 至 65+(—)
性别
All

入选标准

  • Aged 60-85 years at the time of inclusion., Willing and able to come to the vaccination location at a randomly assigned timeslot., Available for the follow-up period of 6 months., Have provided written informed consent.

排除标准

  • Known or suspected allergy to any of the vaccine components or having experienced a previous severe adverse reaction to any vaccine., Known to have an increased susceptibility to bleeding (bleeding diathesis), and are therefore not suitable for intramuscular vaccination., Present evidence of serious diseases demanding either regular use of oral immunosuppressive medical treatment, like corticosteroids, three months prior to study enrolment, or demanding acute use of high dose oral immunosuppressives two weeks prior study to study enrolment., Receipt of an organ- or bone marrow transplant, Receipt of chemotherapy in the previous year., Receipt of blood products or immunoglobulins, within 3 months before study entry., Known or suspected immunodeficiency, auto-immune disease, any type of cancer., Known to be positive for human immunodeficiency virus, and/or hepatitis C virus and/or hepatitis B virus., Receipt of any vaccine(s), including the COVID-19 vaccine, less than two weeks prior to or within one month after baseline., Receipt of influenza 2024/2025-season vaccine prior to or within one month after baseline.

研究者

发起方
Rijksinstituut voor Volksgezondheid en Milieu (RIVM)

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