A PHASE 3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BNT162B2 (LP.8.1)-ADAPTED VACCINE IN CHILDREN 5 THROUGH 11 YEARS OF AGE CONSIDERED AT HIGH RISK FOR SEVERE COVID-19
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- BioNTech SE
- 入组人数
- 344
- 试验地点
- 56
- 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, called BNT162b2 (2025/2026 formulation).
This study is seeking participants 5 through 11 years of age who:
- have at least 1 underlying condition that puts them at high risk for severe outcomes from COVID-19,
- and are medically stable.
All participants in this study will receive 1 vaccine dose given in the muscle of their arm of a BNT162b2 (2025/2026 formulation) vaccine which targets the COVID-19 virus, specifically the strain selected for the 2025-2026 COVID-19 viral respiratory season.
Participants will take part in this study for about 6 months and will need to visit the clinical study site at least 2 times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
This is an open-label study.
入排标准
- 年龄范围
- 5 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children 5 through 11 years of age at their first appointment.
- •Children with at least 1 underlying stable medical condition that increases their risk of severe COVID-19, as listed in the protocol.
排除标准
- •Children who have had confirmed COVID-19 within the last 5 months (150 days).
- •Children who have received a COVID-19 vaccine, either as part of a research study or an approved vaccine, within the last 5 months (150 days).
- •Children who have received a 2025-2026 seasonal COVID-19 vaccination.
- •Children with a history of myocarditis or pericarditis.
- •Children with a previous or current diagnosis of Multisystem Inflammatory Syndrome in Children (MIS-C)
- •Children with a medical condition wherein they would be considered for a second dose of COVID-19 vaccine to protect against risk of severe COVID-19 based on standard of care.
- •Refer to the study contact for further eligibility details.
研究组 & 干预措施
5-11 Years (Higher-Risk Individuals)
BNT162b2 (2025/2026 formulation)
干预措施: BNT162b2 (2025/2026 formulation) (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
Geometric Mean Fold Rises (GMFRs)
时间窗: From before vaccination to 1 month after vaccination
次要结局
未报告次要终点