Impact of Reactogenicity of the 2024-2025 COVID-19 Vaccines on Health Care Workers and First Responders in the United States
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novavax
- 入组人数
- 660
- 试验地点
- 2
- 主要终点
- Percentage of participants with solicited systemic reactogenicity symptoms.
研究概览
简要总结
To assess the impact of reactogenicity among health care workers and first responders receiving an updated 2024-25 Novavax COVID-19 vaccine as compared with those receiving an updated 2024-25 Pfizer-BioNTech mRNA COVID-19 vaccine
详细描述
This is a prospective interventional study of health care workers (HCW) and first responders (FR) receiving an updated 2024-25 COVID-19 vaccination at the University of Utah (UT). Participants can choose which COVID-19 vaccine type they would like to receive from the study team. For this study, health care workers and first responders are defined as anyone having direct face-to-face contact, defined as being within 3 feet, or about an arm's length, with patients as part of their full-time or part-time (greater than or equal to 20 hours per week) job responsibilities.
Approximately 660 health care workers and first responders from Salt Lake City, Utah and surrounding areas will be enrolled into the study. This study will only enroll participants who intend to get an updated 2024-25 COVID-19 vaccine during Fall/Winter 2024-25 SARS-CoV-2 virus circulation. Eligible participants will choose their desired vaccine type (protein subunit: Novavax, or mRNA: Pfizer). Study vaccinators will then administer the chosen vaccine. Following vaccination, study participants will receive a post vaccination questionnaire 48-hours after vaccine administration. Self-reported information on systemic and local reactogenicity symptoms, socio-demographics, occupational history, medical history, COVID-19 and flu vaccine history, and impact on daily activities and work will be collected through the post vaccination questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Active comparator
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years and older who have received at least one COVID-19 vaccination in the past 4 years
- •Health care workers or first responders who have direct face-to-face contact, defined as being within 3 feet, or about an arm's length, with patients as part of their full-time or part-time (greater than or equal to 20 hours per week) job responsibilities
- •Intends to receive a dose of the updated 2024-25 COVID-19 vaccine
- •Able to understand and provide informed consent
- •Comfortable reading and responding to text messages and emails sent in English or having an interpreter assist them
- •Able and willing to comply with all study requirements
- •Access to a smartphone, tablet, or computer to complete the consent, screener and study questionnaires
排除标准
- •Ongoing participation in other vaccine or investigational product trials within 90 days of study enrollment
- •History of self-reported severe allergic reaction to prior COVID-19 vaccine
- •Receipt of COVID-19 vaccine within 60 days of enrollment
- •Plans to receive additional vaccines within 7 days after the vaccination visit for study enrollment. (Co-administered vaccinations at time or day of COVID-19 vaccination are permissible)
研究组 & 干预措施
Pfizer mRNA COVID-19
Participants will receive a single dose (0.3 ml) of study vaccine Pfizer mRNA COVID-19 vaccine, 2024-2025 formula (KP.2 containing) in the deltoid muscle of the arm.
干预措施: Pfizer mRNA COVID-19 vaccine (Biological)
结局指标
主要结局
Percentage of participants with solicited systemic reactogenicity symptoms.
时间窗: Day 0 to Day 2
Percentage of participants that experienced any solicited systemic reactogenicity symptoms after receiving a single dose of 2024-25 Novavax COVID-19 vaccine or 2024-25 Pfizer-BioNTech mRNA COVID-19 vaccine during the first two days post vaccination.
次要结局
- Percentage of participants with solicited local reactogenicity symptoms.(Day 0 to Day 2)
- Number of Participants with solicited systemic reactogenicity symptoms(Day 0 to Day 2)
- Percentage of participants that experienced multiple solicited systemic reactogenicity symptoms.(Day 0 to Day 2)
- Percentage of participants who experienced any local and systemic solicited reactogenicity symptoms.(Day 0 to Day 2)
- Number of Participants Reporting Perceived Impact on Daily Activities (Work, Social, and Family Life)(Day 0 to Day 2)