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

NCT06831786 | Completed Early Phase 1 Results

• 1 other identifier: REC.66-462-14-1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID - 19

Keywords

co-administration; immunogenicity; cell-medicated immune response; influenza vaccine; COVID-19 vaccine; SARS-CoV-2 vaccine

Outcome Measures

Primary Outcomes (4)

• Geometric Mean (GM) of Interferon-gamma (IFN-γ) Response Against the SARS-CoV-2 Virus at Baseline

  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

  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

  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

  IgG response against the SARS-CoV-2 virus, measured by ELISA.

  4 weeks post vaccination

Study Arms (3)

Bivalent mRNA BNT162b2

ACTIVE COMPARATOR

Administering a booster dose of the bivalent mRNA vaccine BNT162b2.

Biological: Bivalent mRNA SARS-CoV-2 vaccine

Quardrivalent influenza vaccine

EXPERIMENTAL

Administering a VaxigripTetra™

Biological: Quardrivalent influenza vaccine

Co-administration

EXPERIMENTAL

Co-administering bivalent mRNA vaccine BNT162b2 and VaxigripTetra™

Biological: Bivalent mRNA SARS-CoV-2 vaccine; Biological: Quardrivalent influenza vaccine

Interventions

Quardrivalent influenza vaccine BIOLOGICAL

Administering a VaxigripTetra™

Co-administration; Quardrivalent influenza vaccine

Bivalent mRNA SARS-CoV-2 vaccine BIOLOGICAL

Administering a booster dose of the bivalent mRNA vaccine BNT162b2

Bivalent mRNA BNT162b2; Co-administration

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Faculty of Medicine, Prince of Songkla University

Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

COVID-19; Influenza, Human

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Limitations and Caveats

As a single-center pilot study with a limited number of participants, the findings may not be generalizable. The short follow-up duration also restricts conclusions about long-term safety and immune responses.

Results Point of Contact

• Title: Sarunyou Chusri
• Organization: prince of songkla university

sarunyouchusri@hotmail.com

+66897340446

Study Officials

• Sarunyou Chusri, M.D., Ph.D.

  Prince of Songkla University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 18, 2025
• Study Start: March 1, 2024
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: December 4, 2025
• Results First Posted: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)