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| Name | Class |
|---|---|
| Korea University Guro Hospital | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C group | Experimental | Concomitant administration of bivalent mRNA COVID-19 booster and quadrivalent influenza vaccination |
|
| S group (COVID-19 vaccine only) | Placebo Comparator | separate administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later |
|
| S group (influenza vaccine only) | Placebo Comparator | separate administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 28 days after booster dose |
| Measure | Description | Time Frame |
|---|---|---|
| seroconversion rate of neutralizing antibody against SARS-CoV-2 | seroconversion rate of neutralizing antibody against wild type, Omicron BA.5 | at 28 days after booster dose |
| geometric mean titer against SARS-CoV-2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min Joo Choi, Doctor | International St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International St. Mary's hospital | Incheon | Seo-gu | 22711 | South Korea |
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prospective, non-randomized clinical cohort study
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|
| quadrivalent influenza vaccine | Biological | 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 |
|
geometric mean titer against SARS-CoV-2 (Anti-S IgG, neutralizing antibody)
| at 28 days after booster dose |
| seroconversion rate of four influenza strains | seroconversion rate of four influenza strains | at 28 days after immunization |
| seropositive rate of four influenza strains | seropositive rate of four influenza strains | at 28 days after immunization |
| geometric mean titer against four influenza strain | geometric mean titer against four influenza strain | 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 | within 28 days |
| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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