The goal is to evaluate the in-depth immunogenicity analysis (including B-cell and T-cellresponse) of coadministration of a omicron-containing COVID-19 vaccine and influenzavaccine 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.
Biological: Omicron-containing COVID-19 vaccine
The COVID-19 vaccine approved for use in the 2023-2024 season
Biological: influenza vaccine
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
Inclusion Criteria:
- who agreed to receive both booster COVID-19 vaccine and influenza vaccine
- individuals who have received the COVID-19 vaccine three or more times and have
passed at least 3 months after the last vaccination
- individuals with a history of a single SARS-CoV-2 infection during the Omicron
outbreak period (January 2022-February 2023)
Exclusion Criteria:
- individuals with a contraindication to any of the vaccine compounds
- individuals with a history of influenza infection within the past 6 months
Korea University Guro Hospital
Seoul, Guro-gu, Korea, Republic of
International St. Mary's hospital
Incheon, Seo-gu, Korea, Republic of
Min Joo Choi, Principal Investigator
International St. Mary's Hospital