Comparative Immunogenicity of Concomitant vs Sequential mRNA COVID-19 and Influenza Vaccinations

Completed · Phase 4

Conditions studied: Influenza, COVID-19

In brief

This is a prospective, randomized randomized immunologic study of response to influenza and SARS-CoV-2 vaccination across four of the US Influenza Vaccine Effectiveness (Flu VE) Network study sites.

Key facts

Study ID

NCT06020118

Run by

Duke University

People needed

455

Starts

2023-09-25

Expected to finish

2024-05-17

Last updated by the study team

2025-06-13

Who can join

Age: 6 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy children aged 6-11 years and healthy adults aged 18-64 years that have not received the current season's influenza vaccination or a mRNA COVID-19 vaccination in the past 6 months and have already completed at least a two-dose primary series of an mRNA COVID-19 vaccination
• English or Spanish literate
• Email or text message capability for weekly follow-up
• Intention of receiving influenza vaccine and mRNA COVID-19 vaccine based on ACIP-CDC guidelines
• Willing to provide written/electronic informed consent
• Intention of being available for entire study period and able to complete all relevant study procedures, including follow-up phone calls and clinic visits

You may not qualify if…

• Self-reported COVID-19 infection within 3 months prior to enrollment
• Received COVID-19 vaccine within 6 months prior to enrollment
• Received influenza vaccine during the respective influenza season in which the participants are being enrolled
• < 9 years of age and recommended to receive two doses of IIV4 during the respective influenza season in which they are being enrolled
• History of severe allergic reaction after a previous dose of any influenza or COVID-19 mRNA vaccine; or to an influenza or COVID-19 mRNA vaccine component
• Receipt of any licensed vaccine within 6 weeks prior to enrollment in this study or planning receipt of any vaccines within 4 weeks after the receipt of the second vaccine dose administered during study procedures
• Has an immunocompromising condition or taking immunosuppressive medication*
• Received oral, intramuscular or intravenous systemic immunosuppressants, or immune modifying drugs for >14 days in total within 6 months prior to any study vaccine dose (for corticosteroids ≥ 20 mg/day of prednisone equivalent).
• * Note: Topical medications are allowed
• Received immunoglobulin, SARS-CoV-2 immunoglobulin, SARS-CoV-2 monoclonal antibody, or blood-derived products, within 3 months prior any study vaccine dose.
• History of Guillain-Barré syndrome
• History of myocarditis or pericarditis
• History of multisystem inflammatory syndrome in children (MIS-C) or adults (MIS-A)
• Currently pregnant, planning to become pregnant within the first three months of the study per participant self-report or likely to be pregnant per screening criteria
• Bleeding disorder diagnosed by a healthcare provider or bleeding difficulties with intramuscular injections or blood draws.
• Has injury or other reason why deltoid site on both arms cannot be used for vaccinations
• Any condition which, in the opinion of the investigators, may pose a health risk to the participant or interfere with the evaluation of the study objectives
• Temporary Delay Criteria: History of febrile illness (> 100.0°F or 37.8°C) within the past 72 hours prior to vaccine administration

Where it is running

• Valleywise Health Comprehensive Health Center — Phoenix, Arizona, United States
• ASU Biodesign Institute — Tempe, Arizona, United States
• Centers for Disease Control and Prevention — Atlanta, Georgia, United States
• Washington University IDCRU — St Louis, Missouri, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• VA Northeast Ohio Healthcare System (VANEOHS) — Cleveland, Ohio, United States
• Senders Pediatrics — South Euclid, Ohio, United States
• Department of Family Medicine, University of Pittsburgh School of Medicine — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.