A PHASE 1, OPEN-LABEL, AGE-DESCENDING, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE (RSVpreF) IN CHILDREN 2 TO <18 YEARS OF AGE
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 128
- 试验地点
- 17
- 主要终点
- Percentage of Participants With Local Reactions Within 7 Days After Vaccination
研究概览
简要总结
The purpose of this study is to learn about the safety and immune activity of the vaccine (called RSVpreF) in children 2 to <18 years of age.
This study will identify the dose level to be used in Phase 2/3 trials in this age cohort. All participants will receive one injection of RSVpreF. This study has four study visits, two in-clinic and two telehealth visits. Blood samples will be collected for testing. This study is about 6 months long for each participant and will be conducted in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
盲法说明
This study is open-label therefore no blinding requirements are in place since all participants will receive RSVPreF.
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants 2 to <18 years of age at enrollment
- •Participants 2 to <18 years of age should either be healthy or be considered by the investigator to be at high risk of RSV disease based on the presence of 1 of the following chronic medical conditions:
- •Cystic fibrosis
- •Medically treated asthma
- •Other chronic respiratory diseases and malformations of the lung
- •Down syndrome
- •Neuromuscular disease
- •Cerebral palsy
- •Hemodynamically significant or symptomatic congenital heart disease
- •All participants 2 to <5 years of age must be seropositive for RSV as confirmed by serology.
- •Participants' parent(s)/legal guardian(s) and participants, as age appropriate, who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, and other study procedures, including collection of nasal swabs by participants' parent(s)/legal guardian(s) and by study staff when indicated.
- •The participant's parent(s)/legal guardian is capable of giving signed informed consent as described in the protocol. Depending on the age of the participant and according to local requirements, participants will also be asked to provide assent as appropriate (verbal or written).
排除标准
- •Immunocompromised individuals associated with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- •Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus. Note: Stable type 1 diabetes and hypothyroidism are permitted.
- •Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- •History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
- •Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- •Individuals with a history of epilepsy or other seizure disorders, or a history of seizures and/or other neurological complications following vaccination.
- •Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation. Children who may have been exposed to investigational RSV vaccines through maternal immunization will be permitted.
- •Receipt of investigational or approved monoclonal antibodies against RSV within 6 months before study intervention administration, or planned receipt throughout the study.
- •Receipt of blood/plasma products or immunoglobulins within 28 days before study intervention administration, or planned receipt throughout the study.
- •Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study intervention administration, or planned receipt throughout the study.
- •Note: Systemic corticosteroids are defined as those administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent (eg, for cancer or an autoimmune disease). Inhaled/nebulized, intra-articular, intrabursal, or topical (skin, eyes, or ears) corticosteroids are permitted.
- •Participation in other studies involving study intervention within 28 days prior to study entry and/or for the duration of study participation.
- •Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
研究组 & 干预措施
standard dose in 5 to <18 years olds, healthy
standard dose (120 µg)
干预措施: RSVpreF 120 µg (Biological)
standard dose in 5 to < 18 years olds, with chronic high risk conditions
standard dose (120 µg)
干预措施: RSVpreF 120 µg (Biological)
standard dose in 2 to < 5 years olds
standard dose (120 µg)
干预措施: RSVpreF 120 µg (Biological)
low dose in 5 to <18 years olds, healthy
low dose (60 µg)
干预措施: RSVpreF 60 µg (Biological)
low dose in 5 to <18 years olds, with chronic high risk conditions
low dose (60 µg)
干预措施: RSVpreF 60 µg (Biological)
low dose in 2 to < 5 years olds
low dose (60 µg)
干预措施: RSVpreF 60 µg (Biological)
结局指标
主要结局
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
时间窗: Day 1 through Day 7 after Vaccination
Local reactions were collected in the electronic diary (e-diary) from Day 1 through Day 7 after vaccination. Local reactions included pain at injection site, redness, and swelling. For participants greater than or equal to (\>=) 2 years to \<12 years of age, redness and swelling were graded as mild: 0.5 to 2.0 centimeter (cm), moderate: \>2.0 to 7.0 cm, and severe: \> 7 cm; for participants \>=12 years of age, mild: \> 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm, and severe: \>10 cm. Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
时间窗: Day 1 through Day 7 after Vaccination
Systemic events included fever, fatigue, headache, vomiting, diarrhea, muscle pain and joint pain and were recorded by participants using e-diary. Fever: oral temperature \>= 38.0 degree Celsius (deg C) and categorized as \>=38.0 to 38.4 deg C (mild), \>38.4 to 38.9 deg C (moderate), and \>38.9 to 40.0 deg C (severe). Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity), and severe (prevented daily routine activity). Vomiting was graded mild: 1-2 times in 24 hours (h), moderate: \>2 times in 24h, and severe: required intravenous hydration. Diarrhea was graded mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h and severe: 6 or more loose stools in 24h.
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
时间窗: Within 1 month post Vaccination
AE was defined as any untoward medical occurrence in clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. AEs included serious and all non-serious AE. SAEs were defined as AE that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was congenital anomaly or birth defect; was suspected transmission via Pfizer product of infectious agent, pathogenic or nonpathogenic or was considered to be an important medical event. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were included.
Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study
时间窗: Within 6 months post Vaccination
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAEs were defined as an AE that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability or incapacity; was a congenital anomaly or birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic or that was considered to be an important medical event.
Percentage of Participants Reporting Newly Diagnosed Chronic Medical Condition (NDCMCs) Throughout the Study
时间窗: Within 6 months post Vaccination
An NDCMC was defined as a disease or medical condition, which was not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
次要结局
- Geometric Mean Titer of the Neutralizing Titers for RSV A and RSV B Before Vaccination and 1 Month After Vaccination(Before vaccination and 1 month after vaccination)
- Geometric Mean Fold Rise (GMFR) of the NTs for RSV A and RSV B From Before Vaccination to 1 Month After Vaccination(From before vaccination to 1 month after vaccination)
- Median Frequencies of RSV F Antigen-Specific Cluster of Differentiation 4 (CD4+) Thymus-Derived Lymphocytes (T) Cells Expressing Interferon (IFN) Gamma and Interleukin-4 (IL-4) Before Vaccination and 1 Month After Vaccination(Before vaccination and 1 Month after vaccination)