Flu and COVID-19 vaccine study - Sanofi VBT04

The Clinical Trial Site at the Institute of Tropical Medicine (ITM) is seeking volunteers for a new clinical trial entitled VBT00004 – Flu COVID study from SANOFI. In this study, we will evaluate how well the vaccine protects against flu and COVID-19, compared with an existing standard vaccine.

• For whom: Volunteers from 60 years of age and above

• Start: November 2026

• Duration: 12 months (1 year)

• Study visits:

  • 1 or 2 visits to the study centre

  • 3 follow-up phone calls

• Compensation: Participants will receive compensation for their time

Purpose of study

Influenza (flu) and COVID-19 are contagious respiratory illnesses that share many common symptoms, including fever, cough, fatigue, and shortness of breath. While both can affect anyone, older adults and people with underlying conditions (such as asthma, chronic lung diseases, or diabetes) face a higher risk of serious complications and hospitalization. As both viruses continue to circulate, particularly during the fall and winter months, the burden they place on individuals and healthcare systems is quite significant.

Vaccination is the most effective way to prevent both diseases, yet currently influenza and COVID-19 vaccines must be given separately. A combination vaccine that protects against both illnesses in a single injection could simplify vaccination, improve acceptance, and ultimately help more people stay protected when they need it the most, especially older adults and high-risk groups.

This study aims to evaluate whether such a combination vaccine is safe and effective, bringing us one step closer to more convenient and comprehensive protection against two of the most impactful respiratory illnesses.

How is the research conducted?

When you are invited to participate, you will be screened for participation during the first visit. There are many factors that contribute to this decision, which the study doctor will review together with you. After you agree to participate and the doctor goes through the participation criteria, you may start the study.

The vaccine will be administered on Day 1. Participants will be randomly assigned to one of two visit schedules:

• Visit Schedule 1:

  • 2 visits to the study centre: Day 1 and Day 29

  • 3 follow-up phone calls: Day 9, Month 6, and Month 12

• Visit Schedule 2:

  • 1 visit to the study centre: Day 1

  • 3 follow-up phone calls: Day 29, Month 6, and Month 12

To evaluate how well the new combination vaccine works at preventing flu and COVID-19 infections, participants will additionally be randomly assigned to one of two vaccination groups:

• Group 1: combined COVID and flu vaccine in one arm, and a placebo in the other arm

• Group 2: COVID vaccine in one arm, and the flu vaccine in the other arm

It is important to note that all participants will receive active vaccines, so no one will receive only a placebo. The placebo in Group 1 is solely used to keep the study blinded, ensuring a fair comparison between both approaches.

This is determined entirely at random through a computer system, and neither you nor the study team will know which of the two groups you have been assigned to until after the study has ended.

During the study you will be asked to complete an electronic diary and questionnaire to record whether you experience any symptoms or side effects.

Who can participate?

For this study, we are looking for volunteers aged 60 or older who have previously received a primary COVID-19 vaccination series as well as at least one booster dose.

There are many more criteria that will be checked by the study doctor to determine if you are eligible for participation in the study. These will be reviewed together with you during the first study visit.

Potential risks and inconveniences

Participation in this study involves having a small amount of blood drawn from you 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.

Compensation

Participants will receive compensation for their time. If you commit to participating in the study, we strongly urge you to complete the entire study. However, please know that you can withdraw your participation at any time.

Questions?

Contact us at studies@itg.be.