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

March 24, 2024 updated by: Catholic Kwandong University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Guro-gu
      • Seoul, Guro-gu, Korea, Republic of, 08308
        • Korea University Guro Hospital
    • Seo-gu
      • Incheon, Seo-gu, Korea, Republic of, 22711
        • International St. Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Exclusion Criteria:

  • individuals with a contraindication to any of the vaccine compounds
  • individuals with a history of influenza infection within the past 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: C group
concomitant administration of COVID-19 booster and quadrivalent influenza vaccination
Biological: Omicron-containing COVID-19 vaccine
The COVID-19 vaccine approved for use in the 2023-2024 season
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
Placebo Comparator: S group (COVID-19 vaccine only)
separate administration of influenza vaccination followed by COVID-19 booster 4 weeks later
Biological: Omicron-containing COVID-19 vaccine
The COVID-19 vaccine approved for use in the 2023-2024 season
Placebo Comparator: S group (influenza vaccine only)
separate administration of influenza vaccination followed by COVID-19 booster 4 weeks later
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
geometric mean titer against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Time Frame: at 7, 28 days, 3, 6, and 10-12 months after COVID-19 vaccination
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence rate of adverse events
Time Frame: within 28 days
The incidence rate of adverse events within 7 days, 28 days, and serious adverse events
within 28 days
geometric mean titer against four influenza strain
Time Frame: at 28 days and 7 months after influenza vaccination
geometric mean titer against four influenza strain
at 28 days and 7 months after influenza vaccination
vaccine-induced B-cell responses
Time Frame: at 7, 28 days, 6, and 10-12 months after COVID-19 vaccination
vaccine-induced B-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
vaccine-induced CD4+ T cell responses
Time Frame: at 7, 28 days, 6, and 10-12 months after COVID-19 vaccination
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic Kwandong University

Collaborators

Korea University Guro Hospital

Investigators

  • Principal Investigator: Min Joo Choi, International St. Mary's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2023

Primary Completion (Estimated)

February 25, 2025

Study Completion (Estimated)

June 25, 2025

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

October 17, 2023

First Posted (Actual)

October 19, 2023

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 24, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IS23OIME0055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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