The Efficacy of the 2023-2024 Updated COVID-19 Vaccines Against COVID-19 Infection

NCT06065176 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 00172738
• Study Type: interventional
• Target: 1,188
• Locations: 1 country
• Sites: 1

Brief 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

SARS CoV 2 Infection; Upper Respiratory Tract Infection; Upper Respiratory Disease; COVID-19; Vaccine-Preventable Diseases

Keywords

COVID-19 vaccines; Rapid antigen test; SARS-CoV-2; Vaccine Efficacy; Real World Evidence

Outcome Measures

Primary Outcomes (1)

• Number of Symptomatic SARS-CoV-2 Infections Between Randomized, Study-vaccinated Participants and the Comparator Group

  Difference in the number of symptomatic SARS-CoV-2 infections between randomized, study-vaccinated participants and the comparator group who did not receive an updated COVID-19 vaccine (2023-2024 formula).

  24 weeks after enrollment

Secondary Outcomes (1)

• Number of Symptomatic SARS-CoV-2 Infections Between the Protein Subunit and mRNA Vaccine Groups.

  24 weeks after study enrollment

Study Arms (3)

Novavax COVID-19 booster

ACTIVE COMPARATOR

Participants will receive a single dose (0.5 ml) of study vaccine Novavax COVID-19 vaccine, 2023-2024 formula (XBB containing) in the deltoid muscle of the arm.

Biological: Novavax COVID-19 vaccine (2023-2024 formula XBB containing)

Pfizer COVID-19 booster

ACTIVE COMPARATOR

Participants will receive a single dose (0.3 ml) of study vaccine Pfizer mRNA COVID-19 vaccine, 2023-2024 formula (XBB containing) in the deltoid muscle of the arm.

Biological: Pfizer COVID-19 mRNA vaccine (2023-2024 formula XBB containing)

Non-boosted comparison group

NO INTERVENTION

Participants will not receive a dose of the study vaccine.

Interventions

Novavax COVID-19 vaccine (2023-2024 formula XBB containing) BIOLOGICAL

Participants will receive a single dose of the Novavax vaccine.

Novavax COVID-19 booster

Pfizer COVID-19 mRNA vaccine (2023-2024 formula XBB containing) BIOLOGICAL

Participants will receive a single dose of the Pfizer vaccine.

Pfizer COVID-19 booster

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years
• Previously received ≥ 2-doses of US FDA-authorized mRNA vaccines
• Comfortable reading and responding to text messages and emails sent in English or having an interpreter assist them
• Plan to remain in the greater Salt Lake City area for the next 12 months
• Daily access to the internet (via cell phone, laptop, desktop, or tablet) and a phone with text messaging capabilities
• Willingness to complete weekly symptom and illness surveillance surveys sent via text and email
• Willingness to complete an online survey at enrollment, mid-study, and end-of-study surveys
• Willingness to be contacted periodically by study staff via text, email, and/or telephone as part of study activities
• Willingness to self-collect rapid antigen tests (RAT; approved by FDA EUA for COVID-19 detection) weekly and when prompted for study purposes, and to send results via the study portal
• Willingness to self-collect additional rapid antigen test (approved by FDA EUA for COVID-19 detection) if experiencing a qualifying symptomatic illness or upon RAT-confirmation of an asymptomatic infection
• Willingness to attend in-person visit to receive supply of rapid antigen tests and training on their use (all participants) and to receive a COVID-19 booster (if in randomized group)

You may not qualify if:

• Lives with another person who is already enrolled in this study as reported by the subject on the Eligibility Survey (Appendix C. Eligibility Survey)
• Previous hypersensitivity reaction to the study vaccines as reported by the subject on the Eligibility Survey (Appendix C. Eligibility Survey)
• Recent infection \[Real time Reverse Transcription Polymerase Chain Reaction assay (RT-PCR) and/or RAT confirmed infection ≤ 90 days of trial vaccine administration
• Receipt of a COVID-19 vaccine within ≤ 90 days of trial vaccine administration
• Participation in other vaccine trials
• Medical history of immunosuppression
• Receipt of J\&J vaccine prior to study enrollment
• Receipt of any investigational prevention therapies for SARS-CoV-2 infections, such as prophylactic antiviral medications or other immune system modifying interventions within ≤ 90 days of trial vaccine administration
• Unwillingness to provide electronic consent
• Unwillingness to self-report occupation, work responsibilities, and prior COVID-19 illness.

Sponsors & Collaborators

• Sarang K. Yoon, DO, MOH: lead
• Westat: collaborator
• Novavax: collaborator

Study Sites (1)

University of Utah School of Medicine

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

• Yoon SK, Ellsworth GL, Battan-Wraith S, Phillips AL, Fink RV, Griffin J, Rowley EAK, McKell J, Smith AS, Campbell R, Williams J, Ball SW, Zhao H, Warren B, Rousculp MD, Thiese MS. Real-World Effectiveness and Noninferiority Evaluation and Comparison of Messenger RNA-Based and Protein-Based COVID-19 Vaccines: Protocol for the BEEHIVE Randomized Study With a Hybrid Effectiveness Design. JMIR Res Protoc. 2026 Jan 27;15:e80858. doi: 10.2196/80858.

  PMID: 41592795 DERIVED

MeSH Terms

Conditions

COVID-19; Vaccine-Preventable Diseases; Respiratory Tract Infections; Respiration Disorders

Interventions

NVX-CoV2373 adjuvated lipid nanoparticle

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

These results are preliminary; analyses are ongoing, and the findings have not yet been published.

Results Point of Contact

• Title: Sarang Yoon, PI
• Organization: University of Utah

sarang.yoon@hsc.utah.edu

801-203-0320

Study Officials

• Sarang K Yoon, DO

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will elect whether they are in the vaccinated group or decline to be in the vaccinated group. So, all participants will be aware of their group assignment. However, those participants in the vaccinated group as well as study investigators will be blinded to study arm assignments within the vaccinated group. A limited number of study staff handling and administering the vaccines will be aware of vaccine assignment and will be trained not to divulge vaccine assignment information to the investigator and study team. Study staff administering vaccine will not be involved with study surveillance to avoid involvement with measurement of study outcomes. The study will provide electronic documentation confirming that participants received one of the study vaccines (without indicating which vaccine) with date of vaccine administration. The electronic documentation of vaccine administration will be password protected to maintain blinding.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: This randomized, three arm, active comparator trial will compare the clinical efficacy of a single dose of the Novavax 2023-2024 updated COVID-19 vaccine (Arm 1) with a single dose of the Pfizer mRNA 2023-2024 updated COVID-19 vaccine (Arm 2) as well as non-vaccinated comparison group (Arm 3). The participants who elect to receive a 2023-2024 updated COVID-19 vaccine are randomized into the Novavax (Arm 1) or Pfizer mRNA (Arm 2) vaccine groups. The non-vaccinated comparison group is nonrandomized.

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 3, 2023
• Study Start: November 22, 2023
• Primary Completion: September 2, 2024
• Study Completion: September 9, 2024
• Last Updated: January 28, 2026
• Results First Posted: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)