A Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of an Ad26.RSV.preF-based Vaccine in the Prevention of Lower Respiratory Tract Disease Caused by RSV in Adults Aged 60 Years and Older
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 25,236
- 试验地点
- 218
- 主要终点
- Number of Participants With First Occurrence of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV) Mediated Lower Respiratory Tract Disease (LRTD)
研究概览
简要总结
The study will enroll up to 27,200 participants in order to demonstrate the efficacy of the active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower Respiratory Tract Disease (LRTD) when compared to placebo in adults aged 60 years and above.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be able to work with smartphones/tablets/computers
- •From the time of vaccination through 3 months after vaccination, participant agrees not to donate blood
- •Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
- •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
- •Participants must sign an Inform Consent Form (ICF) indicating that the participant understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study
排除标准
- •Has a serious clinically unstable condition, (example, end-stage renal disease with or without dialysis, clinically unstable cardiac disease), Alzheimer's disease, or any other condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise well-being) or that could prevent, confound, or limit the protocol specified assessments
- •History of malignancy within 5 years before screening not in the following categories: a. Participants with squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix may be enrolled at the discretion of the investigator; b. Participants with a history of malignancy within 5 years, which is considered cured with minimal risk of recurrence per investigator's judgement, can be enrolled
- •Had major surgery (example, major cardiopulmonary or abdominal operations) as per the investigator's judgment within 4 weeks before vaccination, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study
- •Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator, or an employee of the sponsor
- •Contraindication to Intramuscular (IM) injections and blood draws (example, bleeding disorders)
- •Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine)
研究组 & 干预措施
Group 1: Respiratory Syncytial Virus (RSV) vaccine
All participants in the active group will receive a single dose intramuscular (IM) injection of study vaccine on Day 1.
干预措施: Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF (Biological)
Group 2: Placebo
All participants in the placebo group will receive a single IM injection of matching placebo on Day 1.
干预措施: Placebo (Biological)
结局指标
主要结局
Number of Participants With First Occurrence of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV) Mediated Lower Respiratory Tract Disease (LRTD)
时间窗: From Baseline (Day 1) up to 12 months
Number of participants with first occurrence of RT-PCR-confirmed RSV mediated LRTD according to protocol defined criteria were reported. A participant was considered to have RT-PCR-confirmed RSV-mediated LRTD if the following criteria were met: new onset or worsening from baseline of 3 or more of the symptoms as captured on the respiratory infection intensity and impact questionnaire (RiiQ, version 2) at the same assessment time point: cough, short of breath, coughing up phlegm (sputum), and wheezing and confirmation of RSV by RT-PCR in one or more of the nasal swabs, or in the sputum sample. RiiQ symptom scale was a 13-item questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The total LRTD symptom score was calculated as the mean of the 4 lower respiratory scores (cough, short of breath, coughing up phlegm \[sputum\] and wheezing).
次要结局
- Number of Participants With Unsolicited AEs up to 28 Days After Vaccination(Up to 28 days post vaccination on Day 1 (up to Day 29))
- Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV-mediated Acute Respiratory Infection (ARI)(From Baseline (Day 1) up to 12 months)
- Number of Participants With First Occurrence of RT-PCR-Confirmed RSV Mediated LRTD During the Second Year(From Month 12 up to Month 24)
- Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Vaccination(Up to Day 7 post vaccination on Day 1 (up to Day 8))
- Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at 14 Days Post Vaccination(At 14 Days post vaccination on Day 1 (Day 15))
- T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot)(14 days post vaccination on Day 1 (Day 15))
- Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV Mediated ARI During the Second Year(From Month 12 up to Month 24)
- Number of Participants With First Occurrence of Predefined Clinically Relevant Disease Associated With RT-PCR-Confirmed RSV-Mediated ARI Over the Whole Study(Baseline (Day 1) up to 24 months)
- Number of Participants With Serious Adverse Events (SAEs)(28 days post vaccination on Day 1 (Day 29); First year follow-up (from Day 29 up to 6 months, that is, up to Day 154))
- Number of Participants With Potential Adverse Events of Special Interest (AESIs)(28 days post vaccination on Day 1 (Day 29); First year follow-up (from Day 29 up to 6 months, that is, up to Day 154))
- Number of Participants With Solicited Systemic AEs up to 7 Days After Vaccination(Up to Day 7 post vaccination on Day 1 (up to Day 8))
- Geometric Mean Titers (GMTs) of Prefusion F-protein (Pre-F) Antibodies Immunoglobulin G (IgG) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days Post Vaccination(At 14 days post vaccination on Day 1 (Day 15))
- Area Under the Curve (AUC) of the Change From Baseline in Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Total Symptom Scale Score(Baseline (Day 1) up to 24 months)