This is a prospective, randomized randomized immunologic study of response to influenzaand SARS-CoV-2 vaccination across four of the US Influenza Vaccine Effectiveness (Flu VE)Network study sites.
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 cell culture-based influenza vaccine (ccIIV4, Seqirus) and an
approved mRNA COVID-19 vaccine (Moderna) either concomitantly or sequentially, 28 days
apart. Participants (aged 6-11 years and 18-64 years) will be enrolled in the 2023-2024
influenza season.
Demographic and health data (including influenza and COVID-19 vaccination and infection
history) will be collected upon enrollment. Enrolled participants will be randomized to
one of the following interventions (2:1:1) (i) concomitant administration of the mRNA
COVID-19 vaccine (Moderna) and quadrivalent influenza vaccine (ccIIV4, Seqirus);
(ii)sequential administration of the quadrivalent influenza vaccine (ccIIV4, Seqirus) at
Visit 1 (day 0) and the mRNA COVID-19 vaccine(Moderna) at Visit 2 (day 28); (iii)
sequential administration of the mRNA COVID-19 vaccine (Moderna) at Visit 1 (day 0)
followed by the quadrivalent influenza vaccine (ccIIV4, Seqirus) at Visit 2 (day 28).
Participants will not be blinded to vaccine group.
Whole blood samples to isolate sera for immune assays will be collected prior to
vaccination administration at Visit 1 (day 0), Visit 2 (day 28) Visit 3 (day 56;
post-vaccination 2) and Visit 4 (day180; end of local flu circulation). Blood samples to
isolate PBMC and plasma will be collected from a subset of 250 participants (200 adults
and 50 children). If participants exhibit ARI during the study period, the participants
may be asked to present for collection of a nasal swab for viral testing for acute
influenza or SARS-CoV-2 infection (within 10 days after symptom onset), and blood
specimen to isolate sera for immune assays. For participants with confirmed acute
infection, the participants may be asked to present for collection of a
convalescent-phase blood specimen approximately 28 days after acute visit for isolation
of sera, PBMC and plasma.
Biological: Simultaneous Vaccination (Influenza Vaccine and mRNA COVID booster)
Influenza vaccination and mRNA COVID-19 booster will be given at Visit 1.
Biological: Sequential Vaccination (Influenza vaccine then mRNA COVID booster)
Influenza vaccine will be given at Visit 1 and mRNA COVID booster will be given at Visit
2.
Biological: Sequential Vaccination (mRNA COVID booster then Influenza vaccine)
mRNA COVID booster will be given at Visit 1 and Influenza vaccine will be given at Visit
2.
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
- < 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
Valleywise Health Comprehensive Health Center
Phoenix 5308655, Arizona 5551752, United States
ASU Biodesign Institute
Tempe 5317058, Arizona 5551752, United States
Centers for Disease Control and Prevention
Atlanta 4180439, Georgia 4197000, United States
Washington University IDCRU
St Louis 4407066, Missouri 4398678, United States
University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418, United States
VA Northeast Ohio Healthcare System (VANEOHS)
Cleveland 5150529, Ohio 5165418, United States
Senders Pediatrics
South Euclid 5172485, Ohio 5165418, United States
Department of Family Medicine, University of Pittsburgh School of Medicine
Pittsburgh 5206379, Pennsylvania 6254927, United States
Not Provided