CTIS2024-512291-34-00招募中1 期
A phase 3, randomized, open-label, multi-country study to evaluate the immunogenicity, safety, reactogenicity and persistence of a single dose of the RSVPreF3 OA investigational vaccine and different revaccination schedules in adults aged 60 years and above. - 212496
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 1,650
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
- •Male or female participants =60 YOA at first vaccination, who live in the community (CD participants) or in a LTCF (LTCF participants)., Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, attend regular phone calls/study site visits, ability to access and utilize a phone or other electronic communications)., Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure., Participants who are medically stable in the opinion of the investigator at the time of first vaccination. Patients with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.
排除标准
- •Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination, Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol, Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study
研究者
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