NCT06091410

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at below P25 for phase_4 covid19

Timeline
Completed

Started Sep 2023

Longer than P75 for phase_4 covid19

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2025

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

October 17, 2023

Last Update Submit

March 24, 2024

Conditions

COVID-19InfluenzaVaccine ReactionContaminant Injected

Keywords

COVID-19 vaccineinfluenza vaccineimmunogenicityco-administration

Outcome Measures

Primary Outcomes (1)

  • geometric mean titer against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

    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 Outcomes (4)

  • geometric mean titer against four influenza strain

    at 28 days and 7 months after influenza vaccination

  • vaccine-induced B-cell responses

    at 7, 28 days, 6, and 10-12 months after COVID-19 vaccination

  • vaccine-induced CD4+ T cell responses

    at 7, 28 days, 6, and 10-12 months after COVID-19 vaccination

  • The incidence rate of adverse events

    within 28 days

Study Arms (3)

C group

EXPERIMENTAL

concomitant administration of COVID-19 booster and quadrivalent influenza vaccination

Biological: Omicron-containing COVID-19 vaccineBiological: influenza vaccine

S group (COVID-19 vaccine only)

PLACEBO COMPARATOR

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

Biological: Omicron-containing COVID-19 vaccine

S group (influenza vaccine only)

PLACEBO COMPARATOR

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

Biological: influenza vaccine

Interventions

Omicron-containing COVID-19 vaccineBIOLOGICAL

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

C groupS group (COVID-19 vaccine only)
influenza vaccineBIOLOGICAL

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

C groupS group (influenza vaccine only)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Korea University Guro Hospital

Seoul, Guro-gu, 08308, South Korea

Location

International St. Mary's hospital

Incheon, Seo-gu, 22711, South Korea

Location

MeSH Terms

Conditions

COVID-19Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesOrthomyxoviridae Infections

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Min Joo Choi

    International St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: prospective, randomized clinical cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2023

First Posted

October 19, 2023

Study Start

September 25, 2023

Primary Completion

February 25, 2025

Study Completion

June 25, 2025

Last Updated

March 26, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)