A Phase 2b, Randomized, Placebo-controlled, Observer-blind Study in Adults 60 Years of Age and Older to Evaluate the Efficacy, Safety, and Immunogenicity of a Bivalent Protein Vaccine Candidate Against Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 8,000
- 试验地点
- 16
- 主要终点
- Occurrence of the first episode of RSV-LRTD (Lower Respiratory Tract Disease)
研究概览
简要总结
Study VCA25397 is a Phase 2b, observer-blind, randomized, placebo-controlled, parallel, case-driven proof of concept study that will enroll approximately 8000 adults aged 60 years and older to assess the clinical efficacy, safety, and immunogenicity of a single IM (intramuscular) injection of the bivalent RSV+HMPV protein vaccine candidate.
The study will include a Safety Lead-in Cohort that will be enrolled first and will comprise 200 participants aged 60 years and older randomized in a 1:1 ratio to receive either RSV+HMPV protein vaccine or placebo (100 participants per arm).
The enrollment of the Main Cohort will start after the completion of the ESDR (Early Safety Data Review), pending a positive outcome. For the Main Cohort, 7800 participants (3900 participants per arm) will be randomized in a 1:1 ratio to receive either RSV+HMPV protein vaccine or placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Aged 60 years or older on the day of inclusion
- •Participants who, as determined by medical evaluation including medical history, physical examination, and clinical judgment of the Investigator are eligible for inclusion
排除标准
- •Known/suspected immunodeficiency; immunosuppressive therapy/immunomodulators in past 6 months; long-term systemic corticosteroids (eg, prednisone for more than 2 weeks in past 3 months); history of immune-mediated neurological disease. Of note, persons living with stable HIV are not excluded
- •Known systemic hypersensitivity to any of the study intervention components or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
- •Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- •Previous history of Guillain-Barré Syndrome (GBS)
- •Previous vaccination against RSV and/or HMPV (with a licensed or investigational vaccine either as a monovalent vaccine or any combination of the antigens) or previous receipt of RSV and/or HMPV monoclonal antibody
- •The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
研究组 & 干预措施
Safety Lead-in Cohort - Placebo
Single administration of matching placebo
干预措施: Placebo (Biological)
Safety Lead-in Cohort - Experimental
Single administration of IM (intramuscular) injection of the bivalent RSV+HMPV protein vaccine candidate
干预措施: Bivalent RSV+HMPV protein vaccine (Biological)
Main Cohort - Experimental
Single administration of IM (intramuscular) injection of the bivalent RSV+HMPV protein vaccine candidate
干预措施: Bivalent RSV+HMPV protein vaccine (Biological)
Main Cohort - Placebo
Single administration of matching placebo
干预措施: Placebo (Biological)
结局指标
主要结局
Occurrence of the first episode of RSV-LRTD (Lower Respiratory Tract Disease)
时间窗: From 14 days to 12 months after vaccination
Occurrence of the first episode of HMPV-LRTD
时间窗: From 14 days to 12 months after vaccination
次要结局
- Presence of unsolicited AEs reported(Up to 27 days after vaccination)
- Occurrence of the first episode of RSV-LRTD and/or HMPV-LRTD(From 14 days to 12 months after vaccination)
- Occurrence of the first episode of RSV-ARD (Acute Respiratory Disease) and/or HMPV-ARD(From 14 days to 12 months after vaccination)
- Occurrence of the first episode of severe RSV-LRTD and/or severe HMPV-LRTD(From 14 days to 12 months after vaccination)
- Occurrence of the first episode of RSV-URTD and/or HMPV-URTD(From 14 days to 12 months after vaccination)
- RSV A, RSV B, and HMPV A, HMPV B serum nAb titers in a subset of participants(At pre-vaccination and 8 days, 28 days, 6 months and 12 months post- vaccination)
- Presence of immediate unsolicited systemic AEs (Adverse Events)(Within 30 minutes after vaccination)
- Presence of solicited injection site and systemic reactions in a subset of participants(Up to 7 days after vaccination)
- Presence of MAAEs (Medically Attended Adverse Events)(Within 6 months after vaccination)
- Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Event of Special Interest)(Within 6 months after vaccination)
- Presence of related SAEs, related AESIs, and fatal SAEs(Up to 12 months post-vaccination)
- Presence of out-of-range biological test results in a subset of participants(7 days after vaccination)