Status:
COMPLETED
Comparative Immunogenicity of Concomitant vs Sequential mRNA COVID-19 and Influenza Vaccinations
Lead Sponsor:
Duke University
Collaborating Sponsors:
Centers for Disease Control and Prevention
Arizona State University
Conditions:
Influenza
COVID-19
Eligibility:
All Genders
6-64 years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
This study is a prospective, randomized comparative immunogenicity study in an enrolled cohort. During this study, eligible participants will be randomly assigned to receive an approved quadrivalent c...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2024
Estimated Enrollment :
455 Patients enrolled
Trial Details
Trial ID
NCT06020118
Start Date
September 25 2023
End Date
May 17 2024
Last Update
June 13 2025
Active Locations (8)
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1
Valleywise Health Comprehensive Health Center
Phoenix, Arizona, United States, 85008
2
ASU Biodesign Institute
Tempe, Arizona, United States, 85281
3
Centers for Disease Control and Prevention
Atlanta, Georgia, United States, 30333
4
Washington University IDCRU
St Louis, Missouri, United States, 63110