The goal is to evaluate the in-depth immunogenicity analysis (including B-cell and T-cell response) of coadministration of a omicron-containing COVID-19 vaccine and influenza vaccine among healthy adults during 2023-24 season.
This was an open-label, randomized clinical trial conducted at the International St. Mary's Hospital in Incheon, South Korea. This study included two study groups: Concomitant administration of omicron containing messenger ribonucleic acid (mRNA) COVID-19 booster and quadrivalent influenza vaccination (QIV) and separate administration of influenza vaccination followed by mRNA booster ≥4 weeks later * immunogenicity analysis : Blood was drawn at baseline and follow-up visit 4 weeks, 3 months, 6 months, 10-12 months after immunization(For the COVID-19 vaccine, additional blood sampling will be conducted one week after vaccination). * safety analysis : At 7 days after each vaccine dose, the participants were requested to record the occurrence, severity of solicited adverse events (AEs) through a standardized electronic questionnaire. Participants were also asked to record any unsolicited AEs during the 28 days after vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
62
The COVID-19 vaccine approved for use in the 2023-2024 season
inactivated vaccine containing 15μg hemagglutinin antigen/strain in each 0.5-mL dose, containing four influenza vaccine strains from the 2023-2024 northern hemisphere season
Korea University Guro Hospital
Seoul, Guro-gu, South Korea
International St. Mary's hospital
Incheon, Seo-gu, South Korea
geometric mean titer against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
geometric mean titer against SARS-CoV-2 (Anti-S immunoglobulin G, Neutralizing antibody)
Time frame: at 7, 28 days, 3, 6, and 10-12 months after COVID-19 vaccination
geometric mean titer against four influenza strain
geometric mean titer against four influenza strain
Time frame: at 28 days and 7 months after influenza vaccination
vaccine-induced B-cell responses
vaccine-induced B-cell responses and their immune interactions between COVID-19 and influenza vaccines
Time frame: at 7, 28 days, 6, and 10-12 months after COVID-19 vaccination
vaccine-induced CD4+ T cell responses
vaccine-induced CD4+ T cell responses and their immune interactions between COVID-19 and influenza vaccines
Time frame: at 7, 28 days, 6, and 10-12 months after COVID-19 vaccination
The incidence rate of adverse events
The incidence rate of adverse events within 7 days, 28 days, and serious adverse events
Time frame: within 28 days
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