Study on the Effectiveness of High-Dose vs. Standard-Dose Quadrivalent Influenza Vaccine in Preventing Flu in Adults Aged 65-79 in Galicia, Spain

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What is this study about?

This clinical trial is focused on the prevention of influenza infection in adults aged 65 to 79 years. The study compares two types of flu vaccines: a high-dose quadrivalent influenza vaccine, known as Efluelda, and a standard-dose quadrivalent influenza vaccine, called Influvac Tetra. Both vaccines are designed to protect against four different strains of the flu virus, which include specific types like the B/Phuket/3073/2013-like virus and the A/Victoria/2570/2019 (H1N1)pdm09-like strain.

The purpose of the study is to evaluate how effective the high-dose vaccine is compared to the standard-dose vaccine in reducing the risk of hospitalization due to flu or pneumonia in the specified age group. Participants in the study will receive one of the two vaccines through an injection into the muscle. The study will monitor the health of participants to see if there is a difference in the number of hospitalizations for flu or pneumonia between the two groups.

Throughout the study, researchers will also look at other health outcomes, such as hospitalizations for any heart or lung-related diseases, overall hospitalizations, and overall mortality. The study aims to provide valuable information on which vaccine might offer better protection for older adults against serious flu-related complications.

1 joining the study

Upon joining the study, the participant will have already signed and dated an informed consent form. This confirms understanding and agreement to participate in the trial.

2 receiving the vaccine

Participants will be randomly assigned to receive either a high-dose quadrivalent influenza vaccine (QIV-HD) or a standard-dose quadrivalent influenza vaccine (QIV-SD). The vaccine is administered as an intramuscular injection, which means it is given as a shot into a muscle.

The vaccine is provided in a pre-filled syringe and is a suspension for injection. The high-dose vaccine contains 60 micrograms of hemagglutinin (HA) per strain, which is a component of the influenza virus used to help the body build protection against the flu.

3 monitoring period

After receiving the vaccine, participants will be monitored for any immediate reactions to the injection. This is a standard procedure to ensure safety and well-being.

Participants will be observed over the course of the study to evaluate the effectiveness of the vaccine in preventing hospitalization due to influenza or pneumonia.

4 follow-up and data collection

Throughout the study, participants may be contacted for follow-up to collect data on health outcomes. This includes monitoring for any hospitalizations related to influenza, pneumonia, or other cardio-respiratory diseases.

The study aims to assess the primary endpoint, which is the occurrence of hospitalization due to influenza or pneumonia. Secondary endpoints include hospitalization for any cardio-respiratory disease, all-cause hospitalization, all-cause mortality, and specific hospitalizations for influenza or pneumonia.

5 end of study

The estimated end date for the study is August 31, 2025. At the conclusion of the study, data will be analyzed to determine the relative effectiveness of the high-dose versus standard-dose vaccines in preventing hospitalizations.

Who Can Join the Study?

  • Must be between the ages of 65 and 79 years.
  • Must live in the community and not be eligible to receive the high-dose flu vaccine (QIV-HD) as part of regular care.
  • Must have signed and dated an informed consent form. This means you agree to participate in the study after being told about the details and risks.

Who Cannot Join the Study?

  • Participants must be between the ages of 65 and 79 years old.
  • Both men and women can participate.
  • Participants should not be part of a vulnerable population. A vulnerable population includes groups like pregnant women, children, or people who cannot make decisions for themselves.

Where you can join this trial?

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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
01.10.2023

Trial locations

Quadrivalent Influenza Vaccine is a type of flu vaccine designed to protect against four different flu viruses. In this clinical trial, the vaccine is being tested in two forms: a high-dose version and a standard-dose version. The goal is to see which version is more effective in preventing serious flu-related illnesses, like hospitalization due to influenza or pneumonia, in older adults aged 65 to 79 years. The vaccine works by stimulating the body’s immune system to recognize and fight the flu virus, helping to reduce the risk of getting sick.

Investigated diseases:

Influenza – Influenza, commonly known as the flu, is a contagious respiratory illness caused by influenza viruses. It primarily affects the nose, throat, and sometimes the lungs. The disease typically begins suddenly and can cause symptoms such as fever, cough, sore throat, muscle aches, and fatigue. Influenza spreads through droplets when an infected person coughs, sneezes, or talks. The virus can also be contracted by touching surfaces contaminated with the virus and then touching the face. The illness can range from mild to severe and can lead to complications, especially in older adults and those with weakened immune systems.

Pneumonia – Pneumonia is an infection that inflames the air sacs in one or both lungs, which may fill with fluid or pus. It can be caused by bacteria, viruses, or fungi. Symptoms often include cough with phlegm or pus, fever, chills, and difficulty breathing. The disease can vary in severity from mild to life-threatening, with the severity often depending on the type of germ causing the infection, as well as the age and overall health of the individual. Pneumonia is spread through airborne droplets from a cough or sneeze, or by touching contaminated surfaces. It is more common in older adults, infants, and those with other health problems.

Trial ID:
2023-506977-36-00
Protocol code:
GALFLU
Trial Phase:
Therapeutic confirmatory (Phase III)

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