2024-512291-34-00招募中3 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.
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 738
- 试验地点
- 9
- 主要终点
- Humoral immune response at pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), and at 6 and 12 months post-Dose 1 (Months 6 and 12), in a subset of participants: Neutralizing titers against RSV-A. Neutralizing titers against RSV-B.
研究概览
简要总结
To evaluate the humoral immune response following a 1-dose primary schedule of RSVPreF3 OA investigational vaccine up to 12 months post-Dose 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 主要目的
- Overall study
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
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
结局指标
主要结局
Humoral immune response at pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), and at 6 and 12 months post-Dose 1 (Months 6 and 12), in a subset of participants: Neutralizing titers against RSV-A. Neutralizing titers against RSV-B.
Humoral immune response at pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), and at 6 and 12 months post-Dose 1 (Months 6 and 12), in a subset of participants: Neutralizing titers against RSV-A. Neutralizing titers against RSV-B.
次要结局
- Humoral immune response at pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), and at 6 and 12 months post-Dose 1 (Months 6 and 12), in a subset of participants: RSVPreF3-binding Immunoglobulin G (IgG) antibody concentrations.
- Humoral immune response at Months 18, 24, 30, 36, 42, 48, 54 and 60 post-Dose 1, and at 1 month after each revaccination dose (Months 13, 25, 37 and 49), in a subset of participants: Neutralizing titers against RSV-A and RSV-B RSVPreF3-binding IgG antibody concentrations.
- CMI response at pre-vaccination (Day 1), 30 days post Dose 1 (Day 31), at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 post-Dose 1, and after each revaccination dose (Months 13, 25, 37, 49, 61, 66 and 72), in a subset of participants: Frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-, IFN-, IL-13, IL-17.
- • Occurrence of each solic. admin. site + systemic event during a 4-day Fup period (i.e., on the day of vaccination and 3 subsequent days) after each vaccination. • Occurrence of any unsolic. AE during a 30-day Fup period (i.e., on the day of vaccination and 29 subsequent days) after each vaccination. • Occurrence of all SAEs and pIMDs up to 6 months after each vaccination. • Occurrence of fatal SAEs, related SAEs and related pIMDs from first vaccination (D1) up to study end (M72).
研究者
EU GSK Clinical Trials Call Center
Scientific
GlaxoSmithKline Biologicals
研究点 (9)
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