Impact of Reactogenicity of the 2024-2025 COVID-19 Vaccines on Health Care Workers and First Responders in the United States

NCT06633835 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 2019nCoV-415
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with solicited systemic reactogenicity symptoms.

  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.

  Day 0 to Day 2

Secondary Outcomes (5)

• 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

Study Arms (2)

2024-25 updated Novavax COVID-19

ACTIVE COMPARATOR

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: protein subunit: Novavax COVID-19 vaccine

Pfizer mRNA COVID-19

ACTIVE COMPARATOR

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.

Biological: Pfizer mRNA COVID-19 vaccine

Interventions

protein subunit: Novavax COVID-19 vaccine BIOLOGICAL

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.

Also known as: 2024-25 COVID-19 vaccination

2024-25 updated Novavax COVID-19

Pfizer mRNA COVID-19 vaccine BIOLOGICAL

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.

Also known as: 2024-2025 formula

Pfizer mRNA COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novavax: lead
• University of Utah: collaborator

Study Sites (1)

University of Utah School of Medicine

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

COVID-19; Vaccine-Preventable Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sarang K Yoon, MOH

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Active comparator
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 9, 2024
• Study Start: September 20, 2024
• Primary Completion: June 30, 2025
• Study Completion: August 31, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

US (1)