CTIS2023-508416-35-00进行中（未招募）1 期
A phase 4, randomised vaccination study in healthy adults to investigate the effects of acellular pertussis vaccine on colonisation with Bordetella pertussis using controlled human infection (KIM-study) - PaNaMa ID: 114794
Stichting Radboud University Medical Center0 个研究点目标入组 117 人开始时间: 2024年2月23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
- 117
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 64（—）
- 性别
- All
入选标准
- •Participant is born before 1-9-2004 and < 50 years old on the day of screening (Visit 1; V1), Participant has received all primary pertussis vaccines during childhood, Participant is able to answer all questions of the pre-consent questionnaire correctly, Participant is fully conversant in the Dutch language, Participant is able to arrive within 1h at the Radboudumc from his/her home address. The participant must have a home address and live in the Netherlands, Participant is able to arrive within 3h at the Radboudumc at any time between Bp inoculation (V6) until the day 28 post challenge visit (V12), Participant is willing to take an antibiotic regimen after inoculation with Bp according to the study protocol
排除标准
- •History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention, Smoking: Any smoking event in the last month, including (e-)cigarette, joint, cigar and pipe, Individuals who have a history of receiving pertussis vaccination in the last 5 years, Receipt of any non-study vaccine within 14 days, before and after receiving the study vaccine (V2) or Bp inoculation (V6), For female participants: pregnancy, lactation or intention to become pregnant during the study. Female volunteers are required to use an effective form of contraception during this study, Individuals who have inviolable commitments within the study period from V6 until V12 (28 days in total) to make contact with: •infants aged < 1 year •unimmunized children aged < 4 years •pregnant women >32 weeks who have not received pertussis vaccination at least a week prior to contact •chronically ill patients (e.g. asthma, COPD, heart diseases), Individuals who have household contacts working with •infants aged < 1 year •pregnant women
研究者
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