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OpenTrials
Completed

NCT Number: NCT05970887

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

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Key information

Conditions

Immune Response Safety

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

International St. Mary's hospital

Incheon, Seo-gu, 22711, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

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

    Time frame: at 28 days after booster dose

    seroconversion rate of anti-SARS-CoV-2 S IgG

Secondary outcomes

  1. seroconversion rate of neutralizing antibody against SARS-CoV-2

    Time frame: at 28 days after booster dose

    seroconversion rate of neutralizing antibody against wild type, Omicron BA.5

  2. geometric mean titer against SARS-CoV-2

    Time frame: at 28 days after booster dose

    geometric mean titer against SARS-CoV-2 (Anti-S IgG, neutralizing antibody)

  3. seroconversion rate of four influenza strains

    Time frame: at 28 days after immunization

    seroconversion rate of four influenza strains

  4. seropositive rate of four influenza strains

    Time frame: at 28 days after immunization

    seropositive rate of four influenza strains

  5. geometric mean titer against four influenza strain

    Time frame: at 28 days after immunization

    geometric mean titer against four influenza strain

  6. The incidence rate of adverse events (AEs)

    Time frame: within 28 days

    The incidence rate of AEs within 7 days, AEs within 28 days, and serious AEs

Sponsors and collaborators

Lead sponsor

Catholic Kwandong University

Other

Collaborators

  • Korea University Guro Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 1, 2023
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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