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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06091410
• Other study ID #: IS23OIME0055
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: September 25, 2023
• Est. completion date: June 25, 2025

Study information

• Verified date: March 2024
• Source: Catholic Kwandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: June 25, 2025
• Est. primary completion date: February 25, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Influenza
• Influenza, Human
• Vaccine Reaction

Intervention

Biological:
• Omicron-containing COVID-19 vaccine
The COVID-19 vaccine approved for use in the 2023-2024 season
• 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

Locations

Country	Name	City	State
Korea, Republic of	International St. Mary's hospital	Incheon	Seo-gu
Korea, Republic of	Korea University Guro Hospital	Seoul	Guro-gu

Sponsors (2)

Lead Sponsor	Collaborator
Catholic Kwandong University	Korea University Guro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	geometric mean titer against four influenza strain	geometric mean titer against four influenza strain	at 28 days and 7 months after influenza vaccination
Secondary	vaccine-induced B-cell responses	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
Secondary	vaccine-induced CD4+ T cell responses	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
Secondary	The incidence rate of adverse events	The incidence rate of adverse events within 7 days, 28 days, and serious adverse events	within 28 days