Clinical trial NCT05970887: Immunogenicity and Safety of Concomitant Administration of Bivalent COVID-19 Vaccines With Influenza Vaccines
Official title: Immunogenicity and Safety of Concomitant Administration of Omicron-containing Bivalent COVID-19 Vaccines With Seasonal Influenza Vaccines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Immune Response
Safety
Lead sponsor: Catholic Kwandong University
Sponsor class: OTHER
Collaborators: name: Korea University Guro Hospital
First posted: 2023-08-01
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, non-randomized clinical cohort study
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: seroconversion rate of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) immunoglobulin (IgG) between the C and S groups
timeFrame: at 28 days after booster dose
Secondary outcomes:
measure: seroconversion rate of neutralizing antibody against SARS-CoV-2
timeFrame: at 28 days after booster dose
measure: geometric mean titer against SARS-CoV-2
timeFrame: at 28 days after booster dose
measure: seroconversion rate of four influenza strains
timeFrame: at 28 days after immunization
measure: seropositive rate of four influenza strains
timeFrame: at 28 days after immunization
measure: geometric mean titer against four influenza strain
timeFrame: at 28 days after immunization
measure: The incidence rate of adverse events (AEs)
timeFrame: within 28 days
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: International St. Mary's hospital
state: Seo-gu
Study officials:
affiliation: International St. Mary's Hospital
name: Min Joo Choi, Doctor
role: PRINCIPAL_INVESTIGATOR
References: