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

NCT05970887 | Completed Phase 4 FDA Drug

• 1 other identifier: IS22OISE0060
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Response; Safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• seroconversion rate of neutralizing antibody against SARS-CoV-2

  at 28 days after booster dose

• geometric mean titer against SARS-CoV-2

  at 28 days after booster dose

• seroconversion rate of four influenza strains

  at 28 days after immunization

• seropositive rate of four influenza strains

  at 28 days after immunization

• geometric mean titer against four influenza strain

  at 28 days after immunization

Study Arms (3)

C group

EXPERIMENTAL

Concomitant administration of bivalent mRNA COVID-19 booster and quadrivalent influenza vaccination

Biological: bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine; Biological: quadrivalent influenza vaccine

S group (COVID-19 vaccine only)

PLACEBO COMPARATOR

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

S group (influenza vaccine only)

PLACEBO COMPARATOR

separate administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later

Biological: quadrivalent influenza vaccine

Interventions

bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine BIOLOGICAL

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.

C group; S group (COVID-19 vaccine only)

quadrivalent influenza vaccine BIOLOGICAL

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

C group; S group (influenza vaccine only)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Catholic Kwandong University: lead
• Korea University Guro Hospital: collaborator

Study Sites (1)

International St. Mary's hospital

Incheon, Seo-gu, 22711, South Korea

Location

MeSH Terms

Interventions

Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Min Joo Choi, Doctor

  International St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: prospective, non-randomized clinical cohort study

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 1, 2023
• Study Start: October 12, 2022
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2023
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)