Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633835
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Impact of Reactogenicity of the 2024-2025 COVID-19 Vaccines on Health Care Workers and First Responders in the United States
Sponsor:
None
Organization:
None
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:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 arms 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 FallWinter 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 FallWinter 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None