A PHASE 3 STUDY IN INDIA TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 540
- 试验地点
- 14
- 主要终点
- Percentage of participants reporting systemic events within 7 days following investigational product administration
研究概览
简要总结
The purpose of this phase 3 multicenter, double-blinded, placebo-controlled study in India is to learn about the safety and immunogenicity of RSVpreF in adults.
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)
盲法说明
Double-blinded, placebo-controlled.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants ≥18 years of age at Visit
- •Participants who are ambulatory and live independently in the community.
- •Participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
- •Applicable to participants 18 through 59 years of age: Participants who are healthy or have stable preexisting diseases. These participants are considered at high risk of RSV disease by having at least 1 reportable stable chronic medical condition(s) that belongs to 1 or more of the following:
- •Chronic heart disease (ie, coronary artery disease, heart failure, or congenital heart disease)
- •Chronic lung disease (ie, COPD, emphysema, asthma, interstitial lung disease, or cystic fibrosis)
- •Nongestational diabetes mellitus type 1 or type 2
- •Severe obesity (body mass index [BMI] ≥40 kg/m2)
- •Chronic liver disease (ie, cirrhosis)
- •Chronic kidney disease (not including end-stage renal disease with or without dialysis)
- •Chronic neurological disease that causes impaired airway clearance or respiratory muscle weakness (ie, poststroke dysphagia, amyotrophic lateral sclerosis, or muscular dystrophy)
- •Chronic hematologic disease (ie, sickle cell disease or thalassemia)
- •Note: A chronic medical condition for this study is defined as:
- •Duration ≥6 months.
- •Requires regular medical follow-up or ongoing prescribed medication or hospitalization in the previous year.
- •Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in the protocol.
排除标准
- •Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- •History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine.
- •Prior history of any subtype of Guillain-Barré syndrome of any etiology.
- •Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
- •Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- •Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, immunosuppressive monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study.
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Biological)
RSVpreF
RSVpreF Vaccine
干预措施: RSVpreF (Biological)
结局指标
主要结局
Percentage of participants reporting systemic events within 7 days following investigational product administration
时间窗: Within 7 days
Describe systemic events following investigational product administration
Proportion of participants reporting local reactions within 7 days following investigational product administration
时间窗: Within 7 days
Describe local reactions following investigational product administration
Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration
时间窗: 1 month after vaccination
Describe AEs occurring through 1 month following administration of investigational product
Percentage of participants reporting serious adverse events (SAEs) throughout the study
时间窗: 3 months after vaccination
Describe SAEs through 3 months following administration of investigational product
Neutralizing Titers (NTs) for RSV A and RSV B expressed as Geometric Mean Titers (GMT)
时间窗: Before vaccination, 1 month after vaccination
NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR)
时间窗: Before vaccination, 1 month after vaccination
NTs for RSV A and RSV B expressed as seroresponse rate
时间窗: 1 month after vaccination
次要结局
未报告次要终点