Study on the Immune Response of COVID-19 Vaccine Tozinameran with Flu Vaccine Combinations in Adults Aged 65 and Over

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What is this study about?

This clinical trial is focused on studying the effects of vaccines for COVID-19 and the flu in adults aged 65 and over. The study will use a licensed COVID-19 mRNA Vaccine known as Comirnaty and two types of flu vaccines: Influvac sub-unit Tetra and Fluad Tetra. The Fluad Tetra vaccine includes an ingredient called MF59 adjuvant, which is added to help boost the body’s immune response.

The purpose of the study is to understand how well the immune system responds when these vaccines are given together. Participants will receive either the COVID-19 vaccine with the adjuvanted flu vaccine, the COVID-19 vaccine with the non-adjuvanted flu vaccine, or the COVID-19 vaccine alone. The study will involve several visits over a period of time, where participants will receive the vaccines and have their immune responses checked through blood tests.

Throughout the study, the safety of the vaccines will be closely monitored. Participants will be asked to report any side effects they experience, such as reactions at the injection site or other symptoms. The study aims to provide valuable information on the effectiveness and safety of these vaccines when given together, which could help improve vaccination strategies for older adults in the future.

1 joining the trial

Upon joining the trial, participants will be required to provide written informed consent. This confirms understanding and agreement to participate in the study.

Participants must be aged 65 years or older and able to comply with the trial protocol requirements.

2 initial vaccination

Participants will receive their first set of vaccinations. This includes a licensed COVID-19 vaccine and a licensed seasonal flu vaccine.

The COVID-19 vaccine used is Comirnaty, administered as a 30 microgram dose through an intramuscular injection.

The flu vaccine may be either Influvac sub-unit Tetra or Fluad Tetra, both administered as a suspension for injection in a pre-filled syringe.

3 monitoring and follow-up

Participants will be monitored for their immune response to the vaccines. Blood samples will be taken on days 0, 10, and 28 to measure antibody levels.

Participants will be observed for any local or systemic adverse events within 7 days of vaccination and any other adverse events within 28 days.

Serious adverse events will be monitored from day 0 until day 90 or the end of the trial.

4 final assessment

On day 90, a final assessment will be conducted to evaluate the longevity of the immune response.

This includes measuring both antibody and cellular immune responses to the vaccines.

Who Can Join the Study?

Willingness to provide written informed consent. This means you agree to participate in the study and understand what it involves.
Men or women aged 65 years or older at the time of consent. You must be at least 65 years old to join the study.
Ability to comply with the trial protocol requirements. This means you can follow the study’s rules and procedures.

Who Cannot Join the Study?

People who are not aged 65 years or older cannot participate.
Individuals who have not received a licensed COVID-19 vaccine are excluded.
Participants who have not received a licensed seasonal flu vaccine are not eligible.
Those who have a known allergy to any component of the vaccines used in the study cannot join.
Individuals with a history of severe allergic reactions, also known as anaphylaxis, to any vaccine are excluded. Anaphylaxis is a serious and rapid allergic reaction that can be life-threatening.
People with a weakened immune system, which means their body has a reduced ability to fight infections, cannot participate.
Participants who are currently receiving treatment that affects the immune system, such as chemotherapy, are not eligible.
Individuals with a current illness that causes a fever or infection are excluded.
Those who have participated in another clinical trial within the last 30 days cannot join this study.
Pregnant or breastfeeding women are not eligible to participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Universitair Ziekenhuis Gent	Gent	Belgium
Eutxkek Uqjkctfrdxvn Mlpyogb Ccnlthf Rlhvtxahf (ekozrdh Mhz	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	03.10.2024
The Netherlands	Not recruiting	03.10.2024

Trial locations

Investigated drugs:

COVID-19 Vaccine is a shot designed to protect people from the coronavirus. In this trial, it is given to older adults to see how well it works when given at the same time as a flu vaccine. The goal is to understand how the body’s immune system responds when both vaccines are administered together.

MF59 Adjuvanted Seasonal Flu Vaccine is a flu shot that includes an extra ingredient called an adjuvant, which helps boost the body’s immune response to the vaccine. This trial is testing how well this flu vaccine works when given with a COVID-19 vaccine in older adults.

Unadjuvanted Seasonal Flu Vaccine is a regular flu shot without any additional ingredients to enhance the immune response. In this study, it is used to compare how the immune system reacts when it is given with a COVID-19 vaccine, as opposed to the adjuvanted version.

Investigated diseases:

COVID-19

COVID-19 – COVID-19 is a respiratory illness caused by the SARS-CoV-2 virus. It primarily spreads through respiratory droplets when an infected person coughs, sneezes, or talks. The disease can start with mild symptoms such as fever, cough, and fatigue, but may progress to more severe respiratory issues. In some cases, it can lead to pneumonia and acute respiratory distress syndrome. The progression of the disease varies widely among individuals, with some experiencing mild symptoms and others developing severe complications. The immune response to the virus can also vary, influencing the course of the disease.

Influenza – Influenza, commonly known as the flu, is a contagious respiratory illness caused by influenza viruses. It spreads through droplets when people with the flu cough, sneeze, or talk. The disease typically begins suddenly with symptoms such as fever, chills, muscle aches, cough, congestion, and fatigue. Influenza can lead to complications like pneumonia, especially in older adults and those with certain health conditions. The severity of the flu can range from mild to severe, and it can affect different people in different ways. The body’s immune response plays a crucial role in how the disease progresses.

Trial ID:

2024-514798-23-00

Protocol code:

ISOLDA

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Immune Response of COVID-19 Vaccine Tozinameran with Flu Vaccine Combinations in Adults Aged 65 and Over

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?