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

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

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.

Study Overview

• Status: Completed
• Conditions: Immune Response; Safety
• Intervention / Treatment: Biological: bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine; Biological: quadrivalent influenza vaccine

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 Type: Interventional
• Enrollment (Actual): 154
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seo-gu
    • Incheon, Seo-gu, Korea, Republic of, 22711
      • International St. Mary's hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: C group; Concomitant administration of bivalent mRNA COVID-19 booster and quadrivalent influenza vaccination	Biological: bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine; The bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine is a combination of 15-µg of mRNA encoding the wild-type (WT) spike protein and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariant.; Biological: quadrivalent influenza vaccine; The quadrivalent influenza vaccine is an inactivated vaccine containing 15μg HA/strain in each 0.5-mL dose, containing four influenza vaccine strains from the 2022-2023 northern hemisphere season
Placebo Comparator: S group (COVID-19 vaccine only); separate administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later	Biological: bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine; The bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine is a combination of 15-µg of mRNA encoding the wild-type (WT) spike protein and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariant.
Placebo Comparator: S group (influenza vaccine only); separate administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later	Biological: quadrivalent influenza vaccine; The quadrivalent influenza vaccine is an inactivated vaccine containing 15μg HA/strain in each 0.5-mL dose, containing four influenza vaccine strains from the 2022-2023 northern hemisphere season

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Catholic Kwandong University
• Collaborators: Korea University Guro Hospital
• Investigators: Principal Investigator: Min Joo Choi, Doctor, International St. Mary's hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2022
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: IS22OISE0060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes