Study on Influenza Immunity: Comparing Nasal FluMist and Injectable Vaxigriptetra Vaccines for Adults

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What is this study about?

This clinical trial is focused on studying the effectiveness of different types of vaccines for preventing Influenza, commonly known as the flu. The study will compare two types of vaccines: a nasal spray vaccine called FluMist and an injectable vaccine known as Vaxigriptetra. The nasal spray vaccine contains live but weakened strains of the flu virus, while the injectable vaccine contains purified antigens, which are parts of the virus that help the body recognize and fight the flu.

The purpose of the study is to understand how these vaccines help the body build immunity, particularly in the airways, which are the passages that carry air to the lungs. Participants in the study will receive either the nasal spray or the injectable vaccine, and some may receive a placebo, which looks like the real vaccine but does not contain any active ingredients. The study will monitor participants over a period of time to see how their immune systems respond to the vaccines.

Throughout the study, researchers will collect samples to measure the body’s immune response. This includes looking at specific cells and antibodies, which are proteins that help fight infections. The study aims to provide insights into how well each vaccine works in establishing immunity against different strains of the flu virus. This information could help improve flu prevention strategies in the future.

1 initial vaccination

Upon joining the study, you will receive your first dose of the influenza vaccine. This could be administered as a nasal spray or as an injectable solution. The nasal spray is called FluMist, and the injectable solution is known as Vaxigriptetra.

The purpose of this step is to introduce the vaccine into your system to help your body develop immunity against the influenza virus.

2 follow-up visits

You will have several follow-up visits after the initial vaccination. These visits are scheduled for 14 days before the vaccination, 7 days after, 28 days after (with a possible variation of plus or minus 5 days), and 90 days after (also with a possible variation of plus or minus 5 days).

During these visits, samples will be collected to measure your body’s immune response. This includes checking for specific immune cells and antibodies in your blood and respiratory secretions.

3 immune response assessment

The study will assess your immune response by measuring the activation of certain immune cells, known as CD4+ T-lymphocytes, and the presence of antibodies in your system.

The goal is to determine if there is a significant increase in these immune markers, which would indicate a successful immune response to the vaccine.

4 completion of trial

The trial is expected to conclude by the end of 2025. Your participation will help researchers understand how well the vaccines work in establishing immunity against different strains of the influenza virus.

Your involvement in the study will contribute to the development of more effective influenza vaccines in the future.

Who Can Join the Study?

Age between 20 and 40 years.
Must not have received any influenza vaccine, as confirmed by medical history and documented in the electronic vaccine registry.
Both men and women can participate.

Who Cannot Join the Study?

Patients who are not within the age range of 3 years and older cannot participate.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like pregnant women, children, or people with certain disabilities.
Patients who have any medical condition that the study is not focusing on cannot participate. The study is specifically looking at Influenza.
Patients who are not able to receive a nasal spray vaccine cannot participate. This study involves a nasal spray vaccine called LAIV (Live Attenuated Influenza Vaccine).
Patients who have received another type of flu vaccine recently may not be eligible. The study compares the nasal spray vaccine to another type called quadrivalent IIV (Inactivated Influenza Vaccine).

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Gentofte Hospital	Hellerup	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	23.12.2024

Trial locations

Investigated drugs:

Live Attenuated Influenza Vaccine (LAIV) is a type of flu vaccine that is given through the nose. It contains a weakened form of the flu virus, which helps your body learn how to fight the flu without causing the actual illness. This vaccine is designed to help your immune system recognize and respond to specific types of the flu virus, potentially providing protection against getting sick from the flu.

Intramuscular Influenza Vaccine (IIV) is another type of flu vaccine that is given as a shot in the arm. It contains inactivated, or killed, flu viruses. This vaccine helps your body build immunity by teaching it to recognize and fight off the flu virus if you are exposed to it in the future. It is designed to protect against multiple strains of the flu virus.

Investigated diseases:

Influenza

Influenza – Influenza is a contagious respiratory illness caused by influenza viruses. It primarily affects the nose, throat, and sometimes the lungs. The disease typically begins suddenly with symptoms such as fever, cough, sore throat, runny or stuffy nose, muscle or body aches, headaches, and fatigue. As the illness progresses, symptoms can become more severe, leading to complications like pneumonia, especially in vulnerable populations. The virus spreads through droplets when an infected person coughs, sneezes, or talks. Recovery usually occurs within a few days to less than two weeks, although some people may experience lingering symptoms.

Trial ID:

2023-506166-31-01

Protocol code:

VAXXAIR TRIAL

NCT ID:

NCT05921448

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Influenza Immunity: Comparing Nasal FluMist and Injectable Vaxigriptetra Vaccines for Adults

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?