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.

Status Active, not recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT06091410
• Study type: Interventional
• Source: Catholic Kwandong University
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: September 25, 2023
• Completion date: June 25, 2025