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

Primary Purpose

COVID-19, Influenza, Vaccine Reaction

Status

Recruiting

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Omicron-containing COVID-19 vaccine

influenza vaccine

About this trial

This is an interventional basic science trial for COVID-19 focused on measuring COVID-19 vaccine, influenza vaccine, immunogenicity, co-administration

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Korea University Guro HospitalRecruiting
International St. Mary's hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

C group

S group (COVID-19 vaccine only)

S group (influenza vaccine only)

Arm Description

concomitant administration of COVID-19 booster and quadrivalent influenza vaccination

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

Outcomes

Primary Outcome Measures

geometric mean titer against SARS-CoV-2

geometric mean titer against SARS-CoV-2 (Anti-S IgG, Neutralizing antibody)

Secondary Outcome Measures

geometric mean titer against four influenza strain

vaccine-induced B-cell responses

vaccine-induced B-cell responses and their immune interactions between COVID-19 and influenza vaccines

vaccine-induced CD4+ T cell responses

vaccine-induced CD4+ T cell responses and their immune interactions between COVID-19 and influenza vaccines

The incidence rate of adverse events

The incidence rate of adverse events within 7 days, 28 days, and serious adverse events

Full Information

NCT ID

NCT06091410

First Posted

October 17, 2023

Last Updated

October 17, 2023

Sponsor

Catholic Kwandong University

Collaborators

Korea University Guro Hospital

1. Study Identification

Unique Protocol Identification Number

NCT06091410

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 25, 2023 (Actual)

Primary Completion Date

December 8, 2023 (Anticipated)

Study Completion Date

December 8, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Catholic Kwandong University

Collaborators

Korea University Guro Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, Influenza, Vaccine Reaction, Contaminant Injected

Keywords

COVID-19 vaccine, influenza vaccine, immunogenicity, co-administration

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

prospective, randomized clinical cohort study

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

C group

Arm Type

Experimental

Arm Description

concomitant administration of COVID-19 booster and quadrivalent influenza vaccination

Arm Title

S group (COVID-19 vaccine only)

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

S group (influenza vaccine only)

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Omicron-containing COVID-19 vaccine

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

influenza vaccine

Intervention Description

inactivated vaccine containing 15μg HA/strain in each 0.5-mL dose, containing four influenza vaccine strains from the 2023-2024 northern hemisphere season

Primary Outcome Measure Information:

Title

geometric mean titer against SARS-CoV-2

Description

geometric mean titer against SARS-CoV-2 (Anti-S IgG, Neutralizing antibody)

Time Frame

at 7 and 28 days after COVID-19 vaccination

Secondary Outcome Measure Information:

Title

geometric mean titer against four influenza strain

Description

geometric mean titer against four influenza strain

Time Frame

at 28 days after influenza vaccination

Title

vaccine-induced B-cell responses

Description

vaccine-induced B-cell responses and their immune interactions between COVID-19 and influenza vaccines

Time Frame

at 7 and 28 days after COVID-19 vaccination

Title

vaccine-induced CD4+ T cell responses

Description

vaccine-induced CD4+ T cell responses and their immune interactions between COVID-19 and influenza vaccines

Time Frame

at 7 and 28 days after COVID-19 vaccination

Title

The incidence rate of adverse events

Description

The incidence rate of adverse events within 7 days, 28 days, and serious adverse events

Time Frame

within 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Min Joo Choi, Doctor

Phone

82-32-290-3939

cowgow@naver.com

First Name & Middle Initial & Last Name or Official Title & Degree

Min Joo Choi

Phone

82-32-290-3939

cowgow@naver.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Min Joo Choi

Organizational Affiliation

International St. Mary's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Korea University Guro Hospital

City

Seoul

State/Province

Guro-gu

ZIP/Postal Code

08308

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joon Young Song

Facility Name

International St. Mary's hospital

City

Incheon

State/Province

Seo-gu

ZIP/Postal Code

22711

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Min Joo Choi, Doctor

Phone

82-32-290-3939

cowgow@naver.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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