Flu vaccine study - GSK Flu006

The Clinical Trial Site at the Institute of Tropical Medicine (ITM) is seeking volunteers for a new clinical trial entitled Flu SV mRNA 006 from GSK. In this study, we will evaluate how well the vaccine protects against flu, compared with an existing standard vaccine.

• For whom: Volunteers aged 65 years and over

• Start: September 2026
  Duration: 6 to 8 months (depending on the end of the flu season)

• Study visits:

  • 2 or 3 visits to the study centre

  • 1 or 2 follow-up phone calls

  • Extra visits are possible in case of flu symptoms

• Compensation: Fixed compensation per study visit

Purpose of study

Influenza, commonly known as flu, is a contagious viral infection that affects millions of people worldwide each year. While most people recover within a few days, flu can lead to serious complications, especially in older adults and people with underlying health conditions. Every year, many hospitalisations and deaths are linked to influenza.

The best way to protect against flu is annual vaccination. However, flu viruses change continuously, which means vaccines need to be updated regularly to remain effective.

The purpose of this study is to compare a new influenza vaccine with the current standard flu vaccine in adults aged 65 years and over. The study will assess how well the vaccines help the body build protection against flu, and will evaluate their safety and tolerability. The results will contribute to the development of improved flu vaccines in the future.

This study has been approved by the relevant Ethics Committee and authorised by the Federal Agency for Medicines and Health Products (FAMHP), in line with EU Clinical Trials Regulations. 

How is the research conducted?

When you are invited to participate, you will be screened during the first visit. Many factors contribute to this decision, and the study doctor will review them with you. Once you have agreed to participate and the doctor has gone through the participation criteria, you may start the study.  The vaccine will be administered on Day 1, and a blood sample will be taken at every on-site visit.

In total, four visits will be planned:

• Day 1 and Day 29: at the study centre

• Day 91: by phone call

• End of the flu season: at the study centre or by phone call

• Extra visits are possible in case of flu symptoms

To evaluate how well the new combination vaccine works at preventing an influenza infection, approximately half of the participants will receive the new vaccine, while the other half will receive the current standard vaccination.  This is randomly determined by a computerised system. Neither you nor the site staff will know which group you belong to, until after the end of the study.

Throughout the study, you will be requested to report in an electronic diary if you experience respiratory symptoms. In case you report certain symptoms for a certain period, you will be asked to come to the study site for a nasal swab and /or perform one at home, so that we can determine the potential presence of influenza virus.

Who can participate?

For this study, we are looking for volunteers aged 65 years or over, who have not been vaccinated against influenza in the previous six months.

Participants living in assisted living facilities or receiving additional support such as home nursing, physiotherapy or other care services, are encouraged to participate. This study also aims to better understand how influenza vaccines work in this important population.

Many more criteria will be checked by the study doctor to determine whether you are eligible to take part. These will be reviewed with you during the first study visit. The most important ones are listed on the registration page.

Potential risks and inconveniences

Participation in this study involves having a small amount of blood drawn at certain time points. The total amount of blood taken does not pose any risk to your health. Only the blood draw itself may cause some discomfort and possibly a bruise. A nasal swab may also be taken, depending on your symptoms. This procedure is not painful but may be experienced as unpleasant.

Compensation

To compensate you for your participation, you will receive a fixed fee for each study visit.

If you commit to participating in the study, we strongly urge you to complete it. However, please know that you can withdraw your participation at any time.

Questions?

Contact us at studies@itg.be.