Clinical trial

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

Name

IS23OIME0055

Description

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 arms

Trial start

2023-09-25

Estimated PCD

2025-02-25

Trial end

2025-06-25

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Omicron-containing COVID-19 vaccine

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

Arms:

C group, S group (COVID-19 vaccine only)

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

Arms:

C group, S group (influenza vaccine only)

Size

Primary endpoint

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

at 7, 28 days, 3, 6, and 10-12 months after COVID-19 vaccination

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, randomized clinical cohort study', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 62, 'type': 'ACTUAL'}}

Updated at

2024-03-26

1 organization

2 products

4 indications

Organization

Catholic Kwandong University

Product

Omicron-containing COVID-19 vaccine

Indication

COVID-19

Indication

Influenza

Indication

Adverse Reaction to Immunization

Indication

Contaminant-Injected

Product

Influenza vaccine