Immunogenicity of COVID-19 Vaccine Co-administration With Influenza Vaccine in Healthy Volunteers (NCT06831786) | Clinical Trial Compass
CompletedEarly Phase 1
Immunogenicity of COVID-19 Vaccine Co-administration With Influenza Vaccine in Healthy Volunteers
Thailand36 participantsStarted 2024-03-01
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 dise…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is already completed and measured immune responses like IFN-γ and IgG antibodies after giving COVID-19 and flu vaccines together — has my doctor seen the results, and do they change any advice about whether I should get both vaccines at the same time?
2Since this was an early Phase 1 study in healthy volunteers, what does that mean for how much we actually know about the safety and immune response of co-administering these vaccines in someone with my specific health history?
3The trial focused on measuring immune markers at baseline and at 4 weeks — does my doctor think those immune response levels are a meaningful signal for real-world protection, or is more research needed before drawing conclusions?
4Given that this study enrolled healthy volunteers and is now completed, would my doctor consider the co-administration approach tested here to be standard practice for me, or is there a reason to get the COVID-19 and flu shots separately instead?
5Are there any published findings from this completed trial that my doctor can share with me, so we can discuss whether the co-administration strategy studied here is something worth considering for my upcoming vaccine schedule?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Geometric Mean (GM) of Interferon-gamma (IFN-γ) Response Against the SARS-CoV-2 Virus at Baseline
Timeframe: Before vaccination
2
Geometric Mean (GM) of Interferon-gamma (IFN-γ) Response Against the SARS-CoV-2 Virus at 4 Weeks
Timeframe: 4 weeks post vaccination
3
Geometric Mean (GM) of IgG Response Against the SARS-CoV-2 Virus at Baseline
Timeframe: before vaccination
4
Geometric Mean (GM) of IgG Response Against the SARS-CoV-2 Virus at 4 Weeks