CTRI/2021/10/037564进行中（未招募）2/3 期
A Randomized, Double-blind, Placebo-controlled, Phase2/3 Adaptive Study to Evaluate the Safety,Reactogenicity, and Immunogenicity of Different Dose Levels of Ad26.COV2.S Administered as a One- or Two dose Regimen in Healthy Adolescents From 12 to 17Years Inclusive
Janssen Vaccines and Prevention BV11 个研究点 分布在 1 个国家目标入组 4,350 人开始时间: 2021年11月15日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,350
- 试验地点
- 11
- 主要终点
- Participants with Solicited
研究概览
简要总结
The primary purpose of this study is to assess the safety,reactogenicity, and humoral immune response ofAd26.COV2.S or placebo administered intramuscularly(IM) as a 1-dose schedule or as a 2-dose schedule (56-day interval) in adolescents (Part 1 and Part 2); and todemonstrate non-inferiority (NI) of immune responsesinduced by 1 dose or 2 doses or of a lower, to bedetermined, dose level of Ad26.COV2.S in adolescentsversus 1 or 2 doses of Ad26.COV2.S in young adults(Part 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •Participant’s age is 12 to 17 years of age at the time of first vaccination Participant must be healthy, in the investigator’s clinical judgement, as confirmed by medical history, physical examination, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe coronavirus disease 2019 COVID19 Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine- Participant and or parent or legal guardian are available and willing to participate for the duration of the study visits and follow up Each participant or participant’s parent or legal guardian must have access to a consistent means of contact either by telephone contact or email or computer.
排除标准
- •Participant has a history of malignancy, bone marrow transplant, or solid organ transplant within 5 years before screening Participant has a known or suspected allergy, history of anaphylaxis, or other serious adverse reactions, related to vaccines or their excipients including specifically the excipients of the study vaccine Use of systemic corticosteroids at an immunosuppressive dose treatment duration more than 14 days for one course or recurrent use within 6 months before administration of study vaccine and during the study Participants with a history of illness or with an ongoing illness that, in the opinion of the investigator, may pose additional risk to the participant if he or she participates in the study Any serious, chronic, or progressive disease example, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, acquired immunodeficiency syndrome AIDS infection, blood dyscrasias, bleeding diathesis, signs of cardiac or renal failure, or severe malnutrition.
结局指标
主要结局
Participants with Solicited
时间窗: 7 days post-dose 1 (Day 8) | ,7 days post-dose 2 (Day | 64)
Parts 1 and 2: Number of
时间窗: 7 days post-dose 1 (Day 8) | ,7 days post-dose 2 (Day | 64)
Local Adverse Events (AEs)
时间窗: 7 days post-dose 1 (Day 8) | ,7 days post-dose 2 (Day | 64)
7 Days Post-dose 1 & 2,Parts 1 and 2:
时间窗: 7 days post-dose 1 (Day 8) | ,7 days post-dose 2 (Day | 64)
次要结局
- Parts 1 and 2: Severe Acute(Respiratory Syndrome)
- Parts 1 and 2: SARS-CoV-2(Neutralizing Antibody Titers as Measured by VNA Titers)
研究者
研究点 (11)
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