Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-03 @ 2:56 PM
Study NCT ID:
NCT06633835
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-10
First Post:
2024-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Reactogenicity of the 2024-2025 COVID-19 Vaccines on Health Care Workers and First Responders in the United States
Sponsor:
Novavax
Organization:
Study Overview
Official Title:
Impact of Reactogenicity of the 2024-2025 COVID-19 Vaccines on Health Care Workers and First Responders in the United States
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHIELD
Brief Summary:
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
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: