The Efficacy of the 2023-2024 Updated COVID-19 Vaccines Against COVID-19 Infection
NCT06065176 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1188
Last updated 2026-01-28
Summary
The purpose of this research study is to find out how well two different 2023-2024 updated COVID-19 vaccines protect people from COVID-19 (the disease caused by the SARS-CoV-2 virus), and to determine if getting a 2023-2024 updated vaccine provides better protection from COVID-19 than not getting a vaccine.
If the participant chooses to get a 2023-2024 updated COVID-19 vaccine as part of this study, they will have a 50/50 chance of receiving either the Novavax or Pfizer mRNA vaccine.
If the participant decides not to get a 2023-2024 updated COVID-19 vaccine, the participant can still participate in other study activities.
STUDY ACTIVITIES:
* An online enrollment survey
* An in-person enrollment visit
* Weekly online surveys for 20 weeks
* Weekly COVID-19 tests for 20 weeks
* Additional online surveys if you have COVID-19 symptoms or tested positive for COVID-19.
* Additional COVID-19 tests if you have COVID-19 symptoms or tested positive.
* Online survey questions in the middle and at the end of the study
Conditions
- COVID-19
- Vaccine-Preventable Diseases
- SARS CoV 2 Infection
- Upper Respiratory Tract Infection
- Upper Respiratory Disease
Interventions
- BIOLOGICAL
-
Novavax COVID-19 vaccine (2023-2024 formula XBB containing)
Participants will receive a single dose of the Novavax vaccine.
- BIOLOGICAL
-
Pfizer COVID-19 mRNA vaccine (2023-2024 formula XBB containing)
Participants will receive a single dose of the Pfizer vaccine.
Sponsors & Collaborators
-
Westat
collaborator OTHER -
Novavax
collaborator INDUSTRY -
Sarang K. Yoon, DO, MOH
lead OTHER
Principal Investigators
-
Sarang K Yoon, DO · University of Utah
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-11-22
- Primary Completion
- 2024-09-02
- Completion
- 2024-09-09
- FDA Drug
- Yes
Countries
- United States
Study Locations
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