International St. Mary's hospital
Incheon, Seo-gu, 22711, South Korea
NCT Number: NCT05970887
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 4
Incheon, Seo-gu, 22711, South Korea
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: at 28 days after booster dose
seroconversion rate of anti-SARS-CoV-2 S IgG
Time frame: at 28 days after booster dose
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 (Anti-S IgG, neutralizing antibody)
Time frame: at 28 days after immunization
seroconversion rate of four influenza strains
Time frame: at 28 days after immunization
seropositive rate of four influenza strains
Time frame: at 28 days after immunization
geometric mean titer against four influenza strain
Time frame: within 28 days
The incidence rate of AEs within 7 days, AEs within 28 days, and serious AEs
Looking for future studies?
Notify MeCatholic Kwandong University
Other
Immunogenicity and Safety of Concomitant Administration of Omicron-containing Bivalent COVID-19 Vaccines With Seasonal Influenza Vaccines
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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