The Efficacy of the 2023-2024 Updated COVID-19 Vaccines Against COVID-19 Infection
NCT ID: NCT06065176
Last Updated: 2026-01-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
1188 participants
INTERVENTIONAL
2023-11-22
2024-09-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to<18 Years) at Risk for SARS-CoV-2
NCT04611802
Phase 3 Boosting Study for the SARS-CoV-2 rS Variant Vaccines
NCT05372588
Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults
NCT05463068
Phase 3 Study of Novavax Vaccine(s) as Booster Dose After mRNA Vaccines
NCT05875701
COVID-19: A Study to Evaluate Safety, Reactogenicity and Immunogenicity of the SARS-CoV-2 mRNA Vaccine CVnCoV in Adults With Co-morbidities
NCT04860258
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Participants in all three study arms will complete an online enrollment survey and will self-schedule an in-person enrollment visit. During the visit, all participants will receive a supply of at-home rapid antigen tests for SARS-CoV-2 infection. Those who choose to be in the vaccinated group will also receive either the Novavax vaccine or the Pfizer mRNA vaccine at random. On the first, second, and seventh day after receiving the vaccine, participants will complete an online post-vaccination survey. Beginning after the enrollment visit for a period of 24 weeks, all participants will complete a weekly rapid at-home test and a weekly online survey that surveils for COVID-like illness (CLI)-associated SARS-CoV-2 virus infection, defined as symptoms in the past 7 days including: fever; chills; malaise; fatigue; headache; cough; shortness of breath; sore throat; runny nose or nasal congestion; nausea or vomiting; diarrhea; muscle or body aches; or change in smell or taste. Participants will upload a photo of each weekly test result to the study portal. Those who report new CLI symptoms and those who test positive on their at-home test will complete additional online surveys concerning their illness, as well as another at-home test on the first and third day after the original test. Additionally, all participants will complete a mid- and end-of study survey about their work, health, and opinions about COVID-19, and any COVID-19 and influenza vaccines received. Finally, participants who tested positive for COVID-19 during the study or who had COVID-19 symptoms but did not test positive will complete an online survey about the duration of symptoms and impact on their health. By Summer 2024, study staff will inform participants when the weekly surveys will end and when to stop testing. At the end of the study, participants in the vaccinated group will be notified of which study vaccine they received.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Novavax COVID-19 booster
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.
Novavax COVID-19 vaccine (2023-2024 formula XBB containing)
Participants will receive a single dose of the Novavax vaccine.
Pfizer COVID-19 booster
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.
Pfizer COVID-19 mRNA vaccine (2023-2024 formula XBB containing)
Participants will receive a single dose of the Pfizer vaccine.
Non-boosted comparison group
Participants will not receive a dose of the study vaccine.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Novavax COVID-19 vaccine (2023-2024 formula XBB containing)
Participants will receive a single dose of the Novavax vaccine.
Pfizer COVID-19 mRNA vaccine (2023-2024 formula XBB containing)
Participants will receive a single dose of the Pfizer vaccine.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Westat
OTHER
Novavax
INDUSTRY
Sarang K. Yoon, DO, MOH
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sarang K. Yoon, DO, MOH
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sarang K Yoon, DO
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Utah School of Medicine
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
00172738
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.