The Efficacy of the 2023-2024 Updated COVID-19 Vaccines Against COVID-19 Infection
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
🗓️ Study Start (Actual) 22 November 2023
🗓️ Primary Completion (Estimated) 30 July 2024
✅ Study Completion (Estimated) 30 July 2024
👥 Enrollment (Estimated) 1500
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Salt Lake City, Utah, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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)

    Exclusion Criteria:

    • * 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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 29 September 2023
  • First Submitted that Met QC Criteria 29 September 2023
  • First Posted 3 October 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 November 2023
  • Last Update Posted 28 November 2023
  • Last Verified November 2023