The goal is to evaluate the immunogenicity and safety of coadministration of a bivalent BA.4/BA.5-adapted COVID-19 booster vaccine, and influenza vaccine among healthy adults during 2022-23 season.
This was an open-label, non-randomized clinical trial conducted at the International St. Mary's Hospital in Incheon, South Korea. This study included two study groups: Concomitant administration of bivalent BA.4/BA.5 mRNA COVID-19 booster and quadrivalent influenza vaccination (QIV) and separate administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later * immunogenicity analysis : Blood was drawn at baseline and follow-up visit 4 weeks (day 28±7) after immunization. * 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
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
154
The bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine is a combination of 15-µg of mRNA encoding the wild-type (WT) spike protein and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariant.
The quadrivalent influenza vaccine is an inactivated vaccine containing 15μg HA/strain in each 0.5-mL dose, containing four influenza vaccine strains from the 2022-2023 northern hemisphere season
International St. Mary's hospital
Incheon, Seo-gu, South Korea
seroconversion rate of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) immunoglobulin (IgG) between the C and S groups
seroconversion rate of anti-SARS-CoV-2 S IgG
Time frame: at 28 days after booster dose
seroconversion rate of neutralizing antibody against SARS-CoV-2
seroconversion rate of neutralizing antibody against wild type, Omicron BA.5
Time frame: at 28 days after booster dose
geometric mean titer against SARS-CoV-2
geometric mean titer against SARS-CoV-2 (Anti-S IgG, neutralizing antibody)
Time frame: at 28 days after booster dose
seroconversion rate of four influenza strains
seroconversion rate of four influenza strains
Time frame: at 28 days after immunization
seropositive rate of four influenza strains
seropositive rate of four influenza strains
Time frame: at 28 days after immunization
geometric mean titer against four influenza strain
geometric mean titer against four influenza strain
Time frame: at 28 days after immunization
The incidence rate of adverse events (AEs)
The incidence rate of AEs within 7 days, AEs within 28 days, and serious AEs
Time frame: within 28 days
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