NCT05101486已完成3 期
A Randomized, Double-blind Phase 3 Study to Assess the Immunogenicity and Safety of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life 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
- 755
- 试验地点
- 13
- 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 of Ad26.RSV.preF-based study vaccine lots representative of different aged vaccine in comparison to a non-aged Ad26.RSV.preF-based study vaccine lot.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Before randomization, a participant must be: a) postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and b) not intending to conceive by any methods
- •From the time of vaccination through 3 months after vaccination, agrees not to donate blood
- •In the investigator's clinical judgment, a 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 able to read, understand, and complete questionnaires in the electronic diary (eDiary)
- •Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
- •Must be able to work with smartphones/tablets/computers
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 conditions or medication
- •Per medical history, participant has chronic active hepatitis B or hepatitis C infection
- •History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
- •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
- •Has had major psychiatric illness and/or drug or alcohol abuse which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures
研究组 & 干预措施
Group 1: Ad26.RSV.PreF-based Vaccine
Experimental
Participants will receive a single intramuscular (IM) injection of Ad26.RSV.PreF-based vaccine on Day 1 (non-aged lot).
干预措施: Ad26.RSV.PreF-based Vaccine (Biological)
Group 2: Ad26.RSV.PreF-based Vaccine
Experimental
Participants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 1).
干预措施: Ad26.RSV.PreF-based Vaccine (Biological)
Group 3: Ad26.RSV.PreF-based Vaccine
Experimental
Participants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 2).
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 vaccine were reported.
次要结局
- 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))
- Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days Post Vaccination(14 days post vaccination on Day 1 (Day 15))
- 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))
- Number of Participants With Unsolicited AEs for 28 Days Post Vaccination(Up to 28 days post vaccination on Day 1 (up to Day 29))
- 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 Solicited Systemic AEs for 7 Days Post Vaccination(Up to Day 7 post vaccination on Day 1 (up to Day 8))
研究者
研究点 (13)
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