Phase 4
N=447
Comparative Immunogenicity of Concomitant vs Sequential mRNA COVID-19 and Influenza Vaccinations
Influenza · COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT06020118 ↗Enrolled (actual)
447
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Percentage of Participants With HAI Seroconversion — 53.3; 52.6; 0.9; 33.5 percentage of participants — p=0.938
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Simultaneous Vaccination (Influenza Vaccine and mRNA COVID booster) (Biological); Sequential Vaccination (Influenza vaccine then mRNA COVID booster) (Biological); Sequential Vaccination (mRNA COVID booster then Influenza vaccine) (Biological)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With HAI Seroconversion |
53.3; 52.6; 0.9; 33.5; 36.8; 1.9 | 0.938 |
| PRIMARY Percentage of Participants With HAI Seroprotection |
88.3; 87.4; 58.9; 71.1; 80.0; 36.5 | 0.894 |
| PRIMARY HAI Geometric Mean Titer |
31.7; 33.6; 34.1; 148.3; 146.6; 34.5 | 0.699 |
| PRIMARY HAI Geometric Mean Fold Rise (GMFR) |
4.7; 4.4; 1.0; 2.8; 3.2; 1.0 | 0.793 |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT06020118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.