A PHASE 3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162B2 RNA-BASED VARIANT-ADAPTED VACCINE CANDIDATE(S) AGAINST SARS-COV-2 IN PARTICIPANTS 12 THROUGH 64 YEARS OF AGE CONSIDERED AT HIGHER RISK OF SEVERE COVID-19, AND PARTICIPANTS ≥65 YEARS OF AGE
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- BioNTech SE
- 入组人数
- 774
- 试验地点
- 38
- 主要终点
- Percentage of participants reporting local reactions
研究概览
简要总结
The purpose of this study is to learn about the safety, tolerability, and immunogenicity of an updated vaccine against COVID-19.
This study is seeking participants 12 through 64 years of age who are considered to be at higher risk for severe COVID-19 disease per study protocol and those 65 years of age and older. All participants in this study will receive 1 shot to their arm of a BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg RNA-based vaccine which targets a circulating variant of SARS-CoV-2 and is selected for the 2025-2026 COVID-19 respiratory virus season. This study is about 6 months for each participant. Participants will either be enrolled in Cohort 1 (Groups 1 and 2) or Cohort 2 (Groups 3 and 4). Participants enrolled in Cohort 1 will have at least 4 visits and participants enrolled in Cohort 2 will have at least 3 visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cohort 1: Participants 18 years of age or older.
- •Cohort 2: Participants 12 years of age or older.
- •Participants 12 through 64 years of age with at least 1 underlying medical condition that increases their risk of severe COVID-19.
排除标准
- •History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
- •History of myocarditis or pericarditis.
- •Cohort 2: Receipt of a COVID-19 vaccine or a confirmed case of COVID-19 (confirmed by signs/symptoms and/or a positive test result based on local testing) less than 5 months (150 days) prior to study enrollment.
- •Refer to the study contact for further eligibility details.
研究组 & 干预措施
Group 1: 18 through 64 years of age (higher-risk individuals)
Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1
干预措施: BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) (Biological)
Group 2: 65 years of age and older
Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1
干预措施: BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) (Biological)
Group 3: 12 through 64 years of age (higher-risk individuals)
Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1
干预措施: BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) (Biological)
Group 4: 65 years of age and older
Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1
干预措施: BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) (Biological)
结局指标
主要结局
Percentage of participants reporting local reactions
时间窗: For up to 7 days after vaccination
Percentage of participants reporting systemic events
时间窗: For up to 7 days after vaccination
Percentage of participants reporting adverse events
时间窗: Through 1 month after vaccination
Percentage of participants reporting serious adverse events
时间窗: Through 6 months after vaccination
Cohort 1: Geometric Mean Titers (GMTs)
时间窗: At 2 weeks after vaccination
Cohort 1: Geometric Mean Fold Rises (GMFRs)
时间窗: From before vaccination to 2 weeks after vaccination
Cohort 1: Percentages of participants with seroresponse
时间窗: 2 weeks after vaccination
Cohort 2: Geometric Mean Fold Rises (GMFRs)
时间窗: From before vaccination to 1 month after vaccination
Percentage of participants reporting local reactions
时间窗: For up to 7 days after vaccination
Percentage of participants reporting systemic events
时间窗: For up to 7 days after vaccination
Percentage of participants reporting adverse events
时间窗: Through 1 month after vaccination
Percentage of participants reporting serious adverse events
时间窗: Through 6 months after vaccination
次要结局
- Cohort 1: Geometric Mean Titers (GMTs)(At 1 month after vaccination)
- Cohort 1: Geometric Mean Fold Rises (GMFRs)(From before vaccination to 1 month after vaccination)
- Cohort 1: Percentages of participants with seroresponse(1 month after vaccination)
- Cohort 2: Geometric Mean Titers (GMTs)(From before vaccination to 1 month after vaccination)
- Cohort 2: Percentages of participants with seroresponse(1 month after vaccination)