NCT06633835

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 660 (estimated)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19
• Vaccine-Preventable Diseases
• SARS CoV 2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	protein subunit: Novavax COVID-19 vaccine	Participants will receive a single dose (0.5 ml) of study vaccine Novavax COVID-19 vaccine, 2024-2025 formula (JN.1 containing) in the deltoid muscle of the arm.
BIOLOGICAL	Pfizer mRNA COVID-19 vaccine	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.

Timeline

• Start date: 2024-09-20
• Primary completion: 2025-06-30
• Completion: 2025-08-31
• First posted: 2024-10-09
• Last updated: 2025-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study