Comparative Immunogenicity of Concomitant vs Sequential mRNA COVID-19 and Influenza Vaccinations
Randomized Study of the Immunogenicity and Duration of Antibody Response Against Circulating SARS-CoV-2 Variant and Influenza Viruses Following Concomitant Versus Sequential Administration of mRNA COVID-19 Vaccine and Quadrivalent Cell Culture-based Influenza Vaccine Among Children and Adults
1 other identifier
interventional
455
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2023
Shorter than P25 for phase_4
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2023
CompletedFirst Posted
Study publicly available on registry
August 31, 2023
CompletedStudy Start
First participant enrolled
September 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2024
CompletedResults Posted
Study results publicly available
June 13, 2025
CompletedJune 13, 2025
June 1, 2025
5 months
August 30, 2023
February 14, 2025
June 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Percentage of Participants With HAI Seroconversion
Number of participants with a seroconversion HAI Titer ≥1:40 at Day 29 if Day 1 titer is \<1:10 or a four-fold rise at Day 29 if Day 1 titer is ≥1:10 for each ccIIV4 antigen in the 2023-2024 influenza season.
Visit 1 (day 1; baseline) to Visit 2 (days 28-42; post-vaccination) for all arms/groups
Percentage of Participants With HAI Seroprotection
Number of participants with a seroprotective HAI titer (≥ 1:40) pre- and post-immunization at day 29 for each ccIIV4 antigen in the 2023-2024 influenza season.
Visit 1 (day 1; baseline; pre-immunization) and Visit 2 (days 28-42; post-immunization) for all arms/groups
HAI Geometric Mean Titer
The geometric mean HAI titer (GMT) for each ccIIV4 antigen in the 2023-2024 influenza season. GMTs were derived by using the anti-log of the mean of the log transformed titers.
Visit 1 (day 1; baseline; pre-immunization) and Visit 2 (days 28-42; post-immunization) for all arms/groups
HAI Geometric Mean Fold Rise (GMFR)
GMFRs and 95% confidence intervals were calculated using a t-distribution on log 2-transformed titers.
Visit 1 (day 1; baseline) to Visit 2 (days 28-42; post-vaccination) for all arms/groups
Study Arms (3)
Group i: Concomitant Vaccination
EXPERIMENTALConcomitant Vaccination (Influenza vaccine and mRNA COVID booster) at Visit 1
Group ii: Influenza Vaccination at Visit 1
EXPERIMENTALSequential vaccination with Influenza vaccination at Visit 1 and mRNA COVID booster at Visit 2
Group iii: mRNA COVID-19 Vaccination at Visit 1
EXPERIMENTALSequential vaccination with mRNA COVID booster at Visit 1 and Influenza vaccination at Visit 2
Interventions
Influenza vaccination and mRNA COVID-19 booster will be given at Visit 1.
Influenza vaccine will be given at Visit 1 and mRNA COVID booster will be given at Visit 2.
mRNA COVID booster will be given at Visit 1 and Influenza vaccine will be given at Visit 2.
Eligibility Criteria
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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Centers for Disease Control and Preventioncollaborator
- Arizona State Universitycollaborator
- University Hospitals Cleveland Medical Centercollaborator
- University of Pittsburghcollaborator
- Washington University School of Medicinecollaborator
- Valleywise Healthcollaborator
- Cleveland VA Medical Centercollaborator
- Senders Pediatricscollaborator
Study Sites (8)
Valleywise Health Comprehensive Health Center
Phoenix, Arizona, 85008, United States
ASU Biodesign Institute
Tempe, Arizona, 85281, United States
Centers for Disease Control and Prevention
Atlanta, Georgia, 30333, United States
Washington University IDCRU
St Louis, Missouri, 63110, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
VA Northeast Ohio Healthcare System (VANEOHS)
Cleveland, Ohio, 44106, United States
Senders Pediatrics
South Euclid, Ohio, 44121, United States
Department of Family Medicine, University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15260, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Emmanuel Walter
- Organization
- Duke University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2023
First Posted
August 31, 2023
Study Start
September 25, 2023
Primary Completion
March 7, 2024
Study Completion
May 17, 2024
Last Updated
June 13, 2025
Results First Posted
June 13, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share