A PHASE 3 CLINICAL STUDY EVALUATING THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162B2 RNA-BASED, VARIANT-ADAPTED VACCINE CANDIDATE(S) AGAINST SARS-COV-2 IN CHILDREN AND ADULTS

BioNTech SE0 个研究点目标入组 700 人开始时间: 2026年8月31日最近更新: 2026年9月1日

适应症

干预措施

试验速览

阶段: 3 期
状态: 尚未招募
发起方: BioNTech SE
入组人数: 700
主要终点: Percentage of participants reporting local reactions or systemic events

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to learn about the safety and effects of updated COVID-19 vaccines (called BNT162b2) in participants 5 Through 64 Years of Age with risk factors for Severe COVID-19, and Participants 65 Years of Age and Older.

This study is seeking participants who:

are medically stable
have not had a recent COVID-19 infection or a recent COVID-19 vaccination
have not received certain routine vaccines recently
participants that are 5 through 64 years of age will need to have at least 1 medical condition that increase their risk of complications from COVID-19.

Participants in Cohort 1 of this study will receive 1 injection into their arm of BNT162b2 vaccine 1 which targets COVID-19. The study team and participants will know which injection they receive.

Participants in Cohort 2 of this study will randomly receive 1 injection into their arm of either: BNT162b2 vaccine 1; BNT162b2 vaccine 2, or BNT162b2 vaccine 3 which targets COVID-19. The study team and participants will not know which injection they receive.

Participants will be in the study for about 6 months and will have at least 3 study visits. Participants will record side effects and complete diaries following visit procedures. For Cohort 1 the study team will collect a nose swab and blood samples at 2 of the 3 visits. For Cohort 2 the study team will collect a nose swab and blood samples at all of the visits.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Triple (Participant, Care Provider, Investigator)

盲法说明

Cohort 1 - No Masking; Cohort 2 - Masking applies: Double Blind, Third-party Unblinded (Participant, Care Provider, Investigator)

入排标准

年龄范围: 5 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Participants 5 years of age or older.
•Participants 5 through 64 years of age should have at least 1 underlying medical condition that increases their risk of severe COVID-

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.
•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 3 months (90 days) prior to study enrolment.
•Refer to the study contact for further eligibility details.