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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-25

Study Completion Date

2025-06-25

Brief Summary

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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.

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Detailed Description

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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

* immunogenicity analysis : Blood was drawn at baseline and follow-up visit 4 weeks, 3 months, 6 months, 10-12 months 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.

Conditions

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COVID-19 Influenza Vaccine Reaction Contaminant Injected

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective, randomized clinical cohort study

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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C group

concomitant administration of COVID-19 booster and quadrivalent influenza vaccination

Group Type EXPERIMENTAL

Omicron-containing COVID-19 vaccine

Intervention Type BIOLOGICAL

The COVID-19 vaccine approved for use in the 2023-2024 season

influenza vaccine

Intervention Type 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

S group (COVID-19 vaccine only)

separate administration of influenza vaccination followed by COVID-19 booster 4 weeks later

Group Type PLACEBO_COMPARATOR

Omicron-containing COVID-19 vaccine

Intervention Type BIOLOGICAL

The COVID-19 vaccine approved for use in the 2023-2024 season

S group (influenza vaccine only)

separate administration of influenza vaccination followed by COVID-19 booster 4 weeks later

Group Type PLACEBO_COMPARATOR

influenza vaccine

Intervention Type 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

Interventions

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Omicron-containing COVID-19 vaccine

The COVID-19 vaccine approved for use in the 2023-2024 season

Intervention Type BIOLOGICAL

influenza vaccine

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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-February 2023)