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

November 16, 2025 updated by: Sarunyou Chusri, Prince of Songkla University

Immunogenicity to SARS-CoV-2 of Co-administering Bivalent mRNA BNT162b2 Booster and Quadrivalent Influenza Vaccine Among Healthy Volunteers: A Pilot Study

This study, a pilot randomized controlled trial, single-blind (outcome assessor), evaluating the immune response (both humoral and cell-mediated) against SARS-CoV-2 and the safety of three different vaccine administration approaches: the SARS-CoV-2 mRNA vaccine alone, the influenza vaccine alone, and the co-administration of both vaccines.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Songkhla, Thailand, 90110
        • Faculty of Medicine, Prince of Songkla University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Thai adults aged 18-60 years, who have vaccinated COVID-19 and influenza vaccine more than 6 months.
  • The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the 1-month follow-up of the study.
  • Individuals who are in good health condition at the time of entry into the trial as determined by medical history, physical examination and clinical judgment of the investigator and meet the requirements of immunization.
  • The subject can provide with informed consent and sign informed consent form (ICF).

Exclusion Criteria:

  • Have history of influenza or COVID-19 infection within 6 months.
  • Have the medical history or family history of convulsion, epilepsy, encephalopathy, and psychosis.
  • Be allergic to any component of the research vaccines or used to have a history of hypersensitivity or serious reactions to vaccination.
  • History of Guillain-Barré syndrome.
  • Women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan within six months of after baseline period.
  • Have infectious diseases, including HIV and SARS-CoV-2 infection or any symptom of common cold.
  • Have history of SARS-CoV-2 infection less than 6 months.
  • Having severe chronic diseases or condition in progress cannot be controlled. For example, poor controlled DM and uncontrolled HT.
  • Have the history of urticaria 1 year before receiving the investigational vaccine.
  • Have known underlying diseases of thrombocytopenia or other coagulation disorders (which may cause contraindications for intramuscular injection).
  • Having needle sickness.
  • Have the history of immunosuppressive therapy, cytotoxic therapy, or systemic corticosteroids.
  • Have received blood products within 4 months before injection of investigational vaccines.
  • Under anti-tuberculosis treatment.
  • Not be able to follow the protocol, or not be able to understand the informed consent according to the researcher's judgment, due to various medical, psychological, social, or other conditions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Bivalent mRNA BNT162b2
Administering a booster dose of the bivalent mRNA vaccine BNT162b2.
Biological: Bivalent mRNA SARS-CoV-2 vaccine
Administering a booster dose of the bivalent mRNA vaccine BNT162b2
Experimental: Quardrivalent influenza vaccine
Administering a VaxigripTetra™
Biological: Quardrivalent influenza vaccine
Administering a VaxigripTetra™
Experimental: Co-administration
Co-administering bivalent mRNA vaccine BNT162b2 and VaxigripTetra™
Biological: Bivalent mRNA SARS-CoV-2 vaccine
Administering a booster dose of the bivalent mRNA vaccine BNT162b2
Biological: Quardrivalent influenza vaccine
Administering a VaxigripTetra™

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Geometric Mean (GM) of Interferon-gamma (IFN-γ) Response Against the SARS-CoV-2 Virus at Baseline
Time Frame: Before vaccination
IFN-γ response against the SARS-CoV-2 virus, measured by the ELISpot assay
Before vaccination
Geometric Mean (GM) of Interferon-gamma (IFN-γ) Response Against the SARS-CoV-2 Virus at 4 Weeks
Time Frame: 4 weeks post vaccination
IFN-γ response against the SARS-CoV-2 virus, measured by the ELISpot assay
4 weeks post vaccination
Geometric Mean (GM) of IgG Response Against the SARS-CoV-2 Virus at Baseline
Time Frame: before vaccination
IgG response against the SARS-CoV-2 virus, measured by ELISA.
before vaccination
Geometric Mean (GM) of IgG Response Against the SARS-CoV-2 Virus at 4 Weeks
Time Frame: 4 weeks post vaccination
IgG response against the SARS-CoV-2 virus, measured by ELISA.
4 weeks post vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse event at 1 and 4 weeks
Time Frame: from vaccination to 4 weeks
Self-reported adverse events at 1 week and assessed by interview at 4 weeks.
from vaccination to 4 weeks
Geometric mean ratio (GMR) of IgG response against the SARS-CoV-2 virus between pre and 4 weeks post vaccination
Time Frame: pre-vaccination to 4 weeks post vaccination
IgG response against the SARS-CoV-2 virus, measured by ELISA at day 0 (pre-vaccination) and at 4 weeks , GMR of each arm.
pre-vaccination to 4 weeks post vaccination
Geometric mean ratio (GMR) of Interferon-gamma (IFN-γ) response against the SARS-CoV-2 virus between pre and 4 weeks post vaccination
Time Frame: pre-vaccination to 4 weeks post vaccination
IFN-γ response against the SARS-CoV-2 virus, measured by the ELISpot assay at day 0 (pre-vaccination) and at 4 weeks , GMR of each arm.
pre-vaccination to 4 weeks post vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prince of Songkla University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sarunyou Chusri, M.D., Ph.D., Prince of Songkla University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC.66-462-14-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will be kept anonymized.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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