Immunogenicity of Concomitant Administration of COVID-19 Vaccines With Influenza Vaccines

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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 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 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.

Official Title
-----------------
Immunogenicity of Concomitant Administration of Omicron-containing COVID-19 Vaccines With Influenza Vaccines : In-depth Immunogenicity Analysis.

Conditions
-----------------
COVID-19, Influenza, Vaccine Reaction, Contaminant Injected

Intervention / Treatment
-----------------
* Biological: Omicron-containing COVID-19 vaccine
* Biological: influenza vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
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-Feburary 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, randomized clinical cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C group<br>concomitant administration of COVID-19 booster and quadrivalent influenza vaccination | Biological: Omicron-containing COVID-19 vaccine<br>* The COVID-19 vaccine approved for use in the 2023-2024 season<br>Biological: influenza vaccine<br>* inactivated vaccine containing 15μg HA/strain in each 0.5-mL dose, containing four influenza vaccine strains from the 2023-2024 northern hemisphere season<br>|
| Placebo Comparator: S group (COVID-19 vaccine only)<br>separate administration of influenza vaccination followed by COVID-19 booster 4 weeks later | Biological: Omicron-containing COVID-19 vaccine<br>* The COVID-19 vaccine approved for use in the 2023-2024 season<br>|
| Placebo Comparator: S group (influenza vaccine only)<br>separate administration of influenza vaccination followed by COVID-19 booster 4 weeks later | Biological: influenza vaccine<br>* inactivated vaccine containing 15μg HA/strain in each 0.5-mL dose, containing four influenza vaccine strains from the 2023-2024 northern hemisphere season<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| geometric mean titer against SARS-CoV-2 | geometric mean titer against SARS-CoV-2 (Anti-S IgG, Neutralizing antibody) | at 7 and 28 days after COVID-19 vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| geometric mean titer against four influenza strain | geometric mean titer against four influenza strain | at 28 days after influenza vaccination | 
| vaccine-induced B-cell responses | vaccine-induced B-cell responses and their immune interactions between COVID-19 and influenza vaccines | at 7 and 28 days 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 and 28 days 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19 vaccine, influenza vaccine, immunogenicity, co-administration