NCT05083585已完成3 期
A Randomized, Double-blind Phase 3 Study to Compare the Immunogenicity of Clinical Trial Material of an Ad26.RSV.preF-based Vaccine for Phase 3 With Clinical Trial Material Representative of Phase 2b in Adults Aged 60 to 75 Years
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 8
- 主要终点
- Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination
研究概览
简要总结
The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses induced by vaccination with one dose of the Phase 3 clinical trial material (CTM) compared with one dose of the Phase 2b CTM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to adhere to the prohibitions and restrictions specified in the protocol
- •Before randomization, a participant must be postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and not intending to conceive by any methods
- •In the investigator's clinical judgment, participant must be in stable health at the time of vaccination. Participants may have underlying illnesses such as hypertension, congestive heart failure, chronic obstructive pulmonary disease, type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable at the time of vaccination, and these conditions receive routine follow-up by the participant's healthcare provider. Participants will be included on the basis of medical history, and vital signs performed between informed consent form (ICF) signature and vaccination
- •Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
- •From the time of vaccination through 3 months after vaccination, agrees not to donate blood
排除标准
- •Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
- •Abnormal function of the immune system resulting from clinical condition or medication
- •History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
- •History of thrombosis with thrombocytopenia syndrome (TTS) or heparin-induced thrombocytopenia and thrombosis (HITT)
- •Has had major surgery (per the investigator's judgment) within 4 weeks before administration of the study vaccine or will not have recovered from surgery per the investigator's judgment at time of vaccination
研究组 & 干预措施
Group 1: Phase 3 Clinical Trial Material (CTM)
Experimental
Participants will receive a single intramuscular (IM) injection of adenovirus serotype 26 (Ad26). respiratory syncytial virus (RSV). prefusion conformation-stabilized F protein (preF)-based vaccine on Day 1, which is a Phase 3 CTM.
干预措施: Ad26.RSV.preF-based vaccine (Biological)
Group 2: Phase 2b CTM
Experimental
Participants will receive a single IM injection of Ad26.RSV.preF-based vaccine on Day 1, which is a Phase 2b CTM.
干预措施: Ad26.RSV.preF-based vaccine (Biological)
结局指标
主要结局
Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination
时间窗: 14 days post vaccination on Day 1 (Day 15)
GMTs of pre-F antibodies as assessed by ELISA at 14 days post administration of Ad26/protein preF RSV based vaccine were reported.
次要结局
- Number of Participants With Solicited Systemic AEs for 7 Days Post Vaccination(Up to Day 7 post vaccination on Day 1 (up to Day 8))
- Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days Post Vaccination(Up to Day 7 post vaccination on Day 1 (up to Day 8))
- Number of Participants With Adverse Event of Special Interests (AESIs) Until 6 Months Post Vaccination(From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183))
- Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at 14 Days Post Vaccination(14 days post vaccination on Day 1 (Day 15))
- Number of Participants With Unsolicited AEs for 28 Days Post Vaccination(Up to Day 28 post vaccination on Day 1 (up to Day 29))
- Number of Participants With Serious Adverse Events (SAEs) Until 6 Months Post Vaccination(From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183))
研究者
研究点 (8)
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