This study is a prospective, randomized clinical trial. During this study, participants will be randomly assigned to receive quadrivalent inactivated influenza vaccine (IIV4) and mRNA COVID-19 vaccine either simultaneously or sequentially, 7-14 days apart. Persons in the simultaneous group will receive mRNA COVID-19 and IIV4 at Visit 1 (Day 1) and a saline placebo injection at Visit 2. Persons in the sequential group will receive mRNA COVID-19 vaccine and a saline placebo at Visit 1 (Day 1) and IIV4 injection at Visit 2. For participants receiving their primary dose series, a second dose of mRNA COVID-19 vaccine will be administered either 3 to 8 weeks or 4 to 8 weeks following the first dose, depending upon the mRNA COVID-19 vaccine provided. For those receiving a booster dose of mRNA COVID-19 only a single mRNA COVID-19 will be received in this study. Solicited symptoms of reactogenicity and adverse events will be assessed on vaccination day and daily during the 7 days following each Vaccination Visit using either electronic or paper symptoms diaries, depending on study participant preference. Quality of life data will be collected using electronic or paper diaries on day of Vaccination Visit 1 and daily during the 7 days following the visit. Serious adverse events and adverse events of special interest will be collected throughout the duration of the study. Participants are followed through Day 121. Serum samples from participants will be collected for determination of SARS-CoV-2 seropositivity at baseline. Serum samples will be taken throughout the study to determine IIV4 and COVID-19 vaccine immunogenicity and for potential future studies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
348
ACIP-CDC recommended vaccine
ACIP recommended vaccine
Saline Control
John Hopkins University
Baltimore, Maryland, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Total Number of Participants With Moderate or More Severe Fever, Chills, Myalgia, or Arthralgia in the Simultaneous Group and the Sequential Group Following Both Vaccination Visit 1 and 2
Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
Time frame: Up to 7 Days Post Vaccination (combined for Visits 1 and 2)
Number of Participants With Moderate or More Severe Fever, Chills, Myalgia, or Arthralgia in the Simultaneous Versus the Sequential Group Following the First Vaccination Visit
Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
Time frame: Up to 7 Days Post Vaccination
Number of Participants With Moderate or More Severe Fever, Chills, Myalgia, or Arthralgia in the Simultaneous Versus Sequential Group Following the Second Vaccination Visit
Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
Time frame: Up to 7 Days Post Vaccination
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
Time frame: Up to 7 Days Post Vaccination
Number of Participants With Observed Serious Adverse Events
Time frame: 120 Days
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