A phase 3b, randomized, open label, multi-country, multi-center, extension and crossover vaccination study to evaluate the immunogenicity and safety of different revaccination schedules and persistence of a single dose of the RSVPreF3 OA vaccine in adults aged 60 years and above who participated in the RSV OA=ADJ-006 study - 222090

GlaxoSmithKline Biologicals0 个研究点目标入组 12,300 人开始时间: 2024年2月23日最近更新: 2024年8月21日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方: GlaxoSmithKline Biologicals
入组人数: 12,300

研究概览入排标准研究者记录与标识符相似试验

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 who were previously enrolled in the RSV OA=ADJ-006 study and received placebo (Placebo group) or a single dose of the RSVPreF3 OA vaccine (RSV_1dose group)., - 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). Note: In case of physical incapacity that would preclude the self-completion of the diary cards, either site staff can assist the participant (for activities performed during site visits) or the participant may assign a caregiver to assist him/her with this activity (for activities performed at home or in the LTCF). However, at no time, the site staff or caregiver will evaluate the participant’s health status while answering diaries or make decisions on behalf of the participant. Refer to Section 8 and Definition of Terms of the Clinical Study Protocol for the definition of caregiver. , - 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 study entry. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study.

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 (no laboratory testing required)., '- Participants who experienced an SAE or pIMD from first study intervention administration in the RSV OA=ADJ-006 study until enrollment in this study that was considered to be possibly or probably related to the study vaccine or non-study concomitant vaccines, either by the investigator or the sponsor, including hypersensitivity reactions., '- Participants with a new onset of a pIMD or exacerbation of a pIMD from first study intervention administration in the RSV OA=ADJ-006 study until enrollment in this study, that, in the opinion of the investigator, exposes the participant to unacceptable risk from subsequent vaccination., '- Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine during the period beginning 30 days before the first study visit, or their planned use during the study period., '- Previous vaccination with an RSV vaccine (investigational or licensed vaccine) and/or planned administration of an RSV vaccine during the study period other than the RSVPreF3 OA vaccine administered during the RSV OA=ADJ-006 study., '- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention (For details on components of study intervention administered, refer to Arexvy SmPC/Prescribing information) [Arexvy Summary of Product Characteristics, 2023; Arexvy Prescribing Information, 2023]., '- Hypersensitivity to latex., '- Serious or unstable chronic illness., '- 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 (e.g., completion of diary cards, attend regular phone calls/study site visits)., '- Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study., '- Any other medical condition that in the judgment of the investigator would make intramuscular injection unsafe., '- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study., - Any history of dementia or any medical condition that moderately or severely impairs cognition and understanding of the informed consent form and/or study procedures. Note: If deemed necessary for clinical evaluation, the investigator can use tools such as Mini-Mental State Exam (MMSE), Mini-Cog or Montreal Cognitive Assessment (MoCA) to determine cognition levels of the participant.

研究者

发起方

GlaxoSmithKline Biologicals

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