jRCT2071200045已完成不适用
A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, AND OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY JAPANESE ADULTS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BioNTech SE
- 入组人数
- 160
- 主要终点
- Local reactions
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age old over 至 85age old under（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •Japanese male or female participants between the ages of 20 and 85 years, inclusive, at randomization.
- •Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
- •Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
- •Capable of giving personal signed informed consent.
排除标准
- •Exclusion Criteria:
- •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.
- •Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus
- •History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg,anaphylaxis) to any component of the study intervention(s).
- •Receipt of medications intended to prevent COVID-
- •Previous confirmed diagnosis of COVID-
- •Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- •Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- •Women who are pregnant or breastfeeding.
- •Previous vaccination with any coronavirus vaccine.
- •Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
- •Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
- •Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
- •Previous participation in other studies involving study intervention containing lipid nanoparticles.
- •Subset only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a >= grade 1 abnormality.
- •Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
结局指标
主要结局
Local reactions
时间窗: 7 days after dose 1 and dose 2
Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
Systemic events
时间窗: 7 days after dose 1 and dose 2
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
SARS-CoV-2 serum neutralizing antibody levels
时间窗: at 1 month after dose 2
expressed as GMTs
SARS-CoV-2 S1-binding IgG levels
时间窗: at 1 month after Dose 2
expressed as GMCs
次要结局
- SARS-CoV-2 serum neutralizing antibody levels(through 1 year after dose 2)
- GMFR in SARS-CoV-2 serum neutralizing titers(through 1 year after dose 2 from baseline)
- SARS-CoV-2 S1-binding IgG levels(through 1 year after dose 2)
- GMFR in SARS-CoV-2 S1-binding IgG levels(through 1 year after dose 2 from baseline)
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