Immunogenicity and Safety of Concomitant Administration of Bivalent COVID-19 Vaccines With Influenza Vaccines

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

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

Official Title
-----------------
Immunogenicity and Safety of Concomitant Administration of Omicron-containing Bivalent COVID-19 Vaccines With Seasonal Influenza Vaccines

Conditions
-----------------
Immune Response, Safety

Intervention / Treatment
-----------------
* Biological: bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine
* Biological: quadrivalent influenza vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: who agreed to receive both bivalent booster COVID-19 vaccine and influenza vaccine Only individuals who had passed at least 3 months after the last confirmation of SARS-CoV-2 infection and/or the third dose of COVID-19 vaccination Exclusion Criteria: Individuals with a contraindication to any of the vaccine compounds were excluded from the study

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: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, non-randomized clinical cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C group<br>Concomitant administration of bivalent mRNA COVID-19 booster and quadrivalent influenza vaccination | Biological: bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine<br>* 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.<br>Biological: quadrivalent influenza vaccine<br>* 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<br>|
| Placebo Comparator: S group (COVID-19 vaccine only)<br>separate administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later | Biological: bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine<br>* 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.<br>|
| Placebo Comparator: S group (influenza vaccine only)<br>separate administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later | Biological: quadrivalent influenza vaccine<br>* 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<br>|

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

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |