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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-12

Study Completion Date

2023-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Immunogenicity of Concomitant Administration of COVID-19 Vaccines With Influenza Vaccines

NCT06091410

COVID-19 Influenza Vaccine Reaction +1 more

ACTIVE_NOT_RECRUITING PHASE4

Immunogenicity of COVID-19 Vaccine Co-administration With Influenza Vaccine in Healthy Volunteers

NCT06831786

COVID - 19

COMPLETED EARLY_PHASE1

A Study of Ad26.COV2.S and Influenza Vaccines in Healthy Adults

NCT05091307

COVID-19 Prevention

COMPLETED PHASE3

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza

NCT05596734

Influenza, Human COVID-19

COMPLETED PHASE2

Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influenza Vaccines in Adults

NCT06279871

COVID-19

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Immune Response Safety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

prospective, non-randomized clinical cohort study

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

C group

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

Group Type EXPERIMENTAL

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

Intervention Type 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

Intervention Type 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

S group (COVID-19 vaccine only)

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

Group Type PLACEBO_COMPARATOR

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

Intervention Type 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.

S group (influenza vaccine only)

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

Group Type PLACEBO_COMPARATOR

quadrivalent influenza vaccine

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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