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Immunogenicity of COVID-19 Vaccine Co-administration With Influenza Vaccine in Healthy Volunteers | Clinical Trials | Clareo Health

COMPLETEDEARLY_PHASE1

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

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

NCT06831786•Prince of Songkla University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Yes

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).
+5 more criteria

Locations (1)

Faculty of Medicine, Prince of Songkla University

Songkhla, Thailand

Key Dates

Start Date

March 1, 2024

Primary Completion Date

May 31, 2024

Completion Date

May 31, 2024

Last Updated

December 4, 2025

Enrollment

ACTUAL participants

Conditions

COVID - 19

Interventions

Bivalent mRNA SARS-CoV-2 vaccine

BIOLOGICAL

Quardrivalent influenza vaccine

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Efficacy of Olfactive Training on Loss of Smell and Taste Caused by SARS CoV2 COVID-19 (Covid-Smell)

COVID-19 Infection and Thoracic Anesthesia?

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