Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site: COVPN 3004 Boost

实施疫苗和治疗评估单位 (VTEU) 临床站点：COVPN 3004 Boost

• 批准号: 10639869
• 负责人: Karen L. Kotloff
• 金额: $ 138.28万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-22 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10639869
• 关键词: 18 year old; Adolescent; Adult; Blinded; Blood; COVID-19; COVID-19 Prevention Network; COVID-19 vaccine; Centers for Disease Control and Prevention (U.S.); Child; Childhood; Classification; Data; Dose; Evaluation; Genes; Holidays; Incidence; Messenger RNA; Participant; Process; Protocols documentation; Public Health; Refrigeration; SARS-CoV-2 positive; SARS-CoV-2 variant; Safety; Series; Ships; Specimen; Time; Vaccination; Vaccines; Variant; Visit; base; booster vaccine; clinical research site; fight against; follow-up; interest; severe COVID-19; symptomatic COVID-19; vaccine evaluation; vaccine platform; variants of concern

Novavax CoVPN 3004 Adult and Pediatric Booster Administration Project Summary/Abstract: Novavax Adult and Pediatric booster To date, 485 adult and 29 pediatric participants have received the initial series of vaccinations, had associated follow-up visits, and participated in a blinded cross-over. We estimate 380 adult and 29 pediatric participants will be invited to receive booster dose of vaccine and participate in associated follow-up visits. Blood and other protocol-required specimens collected at theses visits will be processed, stored, and shipped per protocol. Data will be entered, and data queries will be resolved in a timely manner. Surveillance for illness visits will continue and with the advent of new variants, it is expected illness visits will increase following major holidays with a gradual reduction to follow.

Novavax CoVPN 3004成人和儿童助推器管理 项目概要/摘要： Novavax成人和儿童加强剂 到目前为止，485名成人和29名儿童参与者接受了最初的疫苗接种， 随访访视，并参与盲态交叉。我们估计有380名成人和29名儿童参与者 将被邀请接受加强疫苗注射，并参加相关的随访。血液和其他 将按照方案处理、储存和运输在这些访视时采集的方案要求的标本。 将输入数据，并及时解决数据查询。 将继续监测疾病访视，随着新变种的出现，预计疾病访视将 在重大节假日之后增加，随后逐渐减少。