Immunogenicity and Safety of Concomitant Administration of Bivalent COVID-19 Vaccines With Influenza Vaccines

Phase 4

Completed

• Conditions: Immune Response; Safety

• Registration Number: NCT05970887
• Lead Sponsor: Catholic Kwandong University

Brief Summary

The goal is to evaluate the immunogenicity and safety of coadministration of a bivalent BA.4/BA.5-adapted COVID-19 booster vaccine, and influenza vaccine among healthy adults during 2022-23 season.

Detailed Description

This was an open-label, non-randomized clinical trial conducted at the International St. Mary's Hospital in Incheon, South Korea. This study included two study groups: Concomitant administration of bivalent BA.4/BA.5 mRNA COVID-19 booster and quadrivalent influenza vaccination (QIV) and separate administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later

* immunogenicity analysis : Blood was drawn at baseline and follow-up visit 4 weeks (day 28±7) after immunization.

* 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.

Study Timeline

• Study Start: 2022-10-12
• Primary Completion: 2022-12-15
• Study First Submitted: 2023-07-28
• Study First Submitted QC: 2023-07-28
• Study First Posted: 2023-08-01
• Study Completion: 2023-12-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• who agreed to receive both bivalent booster COVID-19 vaccine and influenza vaccine
• Only individuals who had passed at least 3 months after the last confirmation of SARS-CoV-2 infection and/or the third dose of COVID-19 vaccination

Exclusion Criteria

• Individuals with a contraindication to any of the vaccine compounds were excluded from the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
seroconversion rate of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) immunoglobulin (IgG) between the C and S groups	at 28 days after booster dose	seroconversion rate of anti-SARS-CoV-2 S IgG

Secondary Outcome Measures

Name	Time	Method
seroconversion rate of neutralizing antibody against SARS-CoV-2	at 28 days after booster dose	seroconversion rate of neutralizing antibody against wild type, Omicron BA.5
geometric mean titer against SARS-CoV-2	at 28 days after booster dose	geometric mean titer against SARS-CoV-2 (Anti-S IgG, neutralizing antibody)
geometric mean titer against four influenza strain	at 28 days after immunization	geometric mean titer against four influenza strain
seroconversion rate of four influenza strains	at 28 days after immunization	seroconversion rate of four influenza strains
seropositive rate of four influenza strains	at 28 days after immunization	seropositive rate of four influenza strains
The incidence rate of adverse events (AEs)	within 28 days	The incidence rate of AEs within 7 days, AEs within 28 days, and serious AEs

Trial Locations

Locations (1)

International St. Mary's hospital; 🇰🇷 Incheon, Seo-gu, Korea, Republic of