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| Name | Class |
|---|---|
| Korea University Guro Hospital | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C group | Experimental | concomitant administration of COVID-19 booster and quadrivalent influenza vaccination |
|
| S group (COVID-19 vaccine only) | Placebo Comparator | separate administration of influenza vaccination followed by COVID-19 booster 4 weeks later |
|
| S group (influenza vaccine only) | Placebo Comparator | separate administration of influenza vaccination followed by COVID-19 booster 4 weeks later |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omicron-containing COVID-19 vaccine | Biological | The COVID-19 vaccine approved for use in the 2023-2024 season |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | at 7, 28 days, 3, 6, and 10-12 months after COVID-19 vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| geometric mean titer against four influenza strain | geometric mean titer against four influenza strain | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min Joo Choi | International St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | Guro-gu | 08308 | South Korea | ||
| International St. Mary's hospital |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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prospective, randomized clinical cohort study
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| influenza vaccine | Biological | 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 |
|
| 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 | 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 | within 28 days |
| Incheon |
| Seo-gu |
| 22711 |
| South Korea |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |