NCT06091410

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Catholic Kwandong University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• COVID-19
• Influenza
• Vaccine Reaction
• Contaminant Injected

Interventions

Type	Name	Description
BIOLOGICAL	Omicron-containing COVID-19 vaccine	The COVID-19 vaccine approved for use in the 2023-2024 season
BIOLOGICAL	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

Timeline

• Start date: 2023-09-25
• Primary completion: 2025-02-25
• Completion: 2025-06-25
• First posted: 2023-10-19
• Last updated: 2024-03-26

Locations

2 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study