Study on the Safety and Immune Response of aQIVc HD Vaccine Compared to a Drug Combination for Adults 50 Years and Older at Risk of Flu Complications

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of different types of vaccines for influenza, commonly known as the flu, in adults aged 50 years and older. The study involves a high-dose vaccine called aQIVc HD, which is a cell-derived vaccine enhanced with an ingredient called MF59 to boost the immune response. It is compared with two other vaccines: a non-enhanced vaccine called QIVr and another enhanced vaccine called aQIV, which is derived from eggs.

The purpose of the study is to evaluate how well these vaccines work in producing an immune response and how safe they are for the participants. The study will involve receiving one of the vaccines through an injection. Participants will be monitored for their immune response to the vaccine strains, which are specific types of the flu virus, and for any side effects. The study will last for about a year, with the main focus on the immune response measured at 29 days after vaccination.

Participants will include healthy individuals or those with stable health conditions that increase their risk of complications from the flu. The study aims to ensure that the high-dose vaccine is as effective and safe as the other vaccines. The vaccines are administered using a pre-filled syringe, which is a single-use device. The study will help determine the best vaccine option for older adults to protect them against the flu.

1 joining the study

Upon joining the study, individuals aged 50 years and older, who are healthy or have stable conditions that increase their risk of complications from influenza, will be enrolled. Participants must be able to comply with all study procedures.

2 receiving the vaccine

Participants will receive an injection of one of the following vaccines: aQIVc HD (high-dose MF59-adjuvanted quadrivalent subunit cell-derived influenza vaccine), QIVr (non-adjuvanted quadrivalent recombinant influenza vaccine), or aQIV (MF59-adjuvanted quadrivalent subunit egg-derived influenza vaccine).

The vaccine is administered as a suspension for injection.

3 monitoring and follow-up

Participants will be monitored for any immediate reactions from Day 1 to Day 7 for local and systemic reactions.

Unsolicited adverse events will be recorded from Day 1 to Day 29.

Serious adverse events, adverse events leading to withdrawal, adverse events of special interest, and medically attended adverse events will be monitored from Day 1 to Day 365.

4 immunogenicity assessment

The study aims to evaluate the immune response to the vaccine by measuring antibody levels using a test called the hemagglutination inhibition (HI) assay.

The primary assessment will occur on Day 29 to compare the immune response between different vaccine groups.

5 completion of the study

The study is expected to conclude by June 28, 2025.

Participants will have completed all required follow-ups and assessments by this date.

Who Can Join the Study?

  • Individuals aged 50 years and older.
  • Individuals who are healthy or have stable comorbidities. Comorbidities are other health conditions that a person might have. Stable means these conditions are not currently causing problems.
  • Individuals whose comorbidities increase their risk of complications from influenza infection. Influenza is commonly known as the flu.
  • Individuals who can comply with all study procedures. This means they can follow the instructions and attend all required appointments.

Who Cannot Join the Study?

  • Individuals who are not healthy or do not have stable comorbidities. Comorbidities are other health conditions that a person may have in addition to the main condition being studied.
  • Individuals who are not at increased risk of complications from influenza infection. Influenza is a viral infection that attacks your respiratory system.
  • Individuals who are younger than 50 years old.
  • Individuals who are part of a vulnerable population. This term refers to groups of people who may be at a higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Klinische Forschung Karlsruhe GmbH Karlsruhe Germany
Klinisches Forschungszentrum Dr. Hagemann Hausarztzentrum am Germaniaplatz Essen Germany
Al Mare Perearstikeskus OU Tallin Estonia
Innomedica OÜ Tallin Estonia
Vee Perearstikeskus OÜ Paide Estonia

Other Sites

Site Name City Country Status
Tartu University Hospital Tartu Estonia
Klinische Forschung Berlin GbR Berlin Germany
HELIOS Kliniken Schwerin GmbH Schwerin Germany
Klinische Forschung Hannover-Mitte GmbH Hanover Germany
Klinische Forschung Berlin-Mitte GmbH Berlin Germany
Hautarztpraxis Dr. Leitz Und Kollegen Stuttgart Germany
Klinische Forschung Hamburg GmbH Hamburg Germany
Clinical Research Hamburg GmbH Hamburg Germany
Kliiniliste Uuringute Keskus OÜ Tartu Estonia
Zealand University Hospital, Department of Cardiology Roskilde Denmark
Studienzentrum Bocholderstrasse Essen Germany
Center for Clinical and Basic Research AS Tallin Estonia
Merelahe Perearstikeskus OÜ Tallin Estonia
Exdcsr Gjsx Berlin Germany
Spmgdskbthjbns Fom Rhgsepcd Leipzig Germany
Auperm Uomkatojti Hjtiynks Aarhus Denmark
Hurrqaxn Hjyqyuzn Hvidovre Denmark
Kzccomumg Fyfhedpdy Dyhavrq Gpsb Dresden Germany
Uvs Kwkngtaim Ffrvcikaq Essen Germany
Deaatdgmszbe Qtuqu Mainz Germany

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

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
02.10.2023
Estonia Estonia
Not recruiting
02.10.2023
Germany Germany
Not recruiting
02.10.2023

Trial locations

aQIVc HD is a high-dose influenza vaccine designed to protect against four different strains of the flu virus. It is made using a process that involves growing the virus in cells, which can help produce a strong immune response. This vaccine also includes an ingredient called an adjuvant, which helps boost the body’s immune response to the vaccine, making it more effective, especially in older adults.

QIVr is a type of flu vaccine that also targets four different strains of the influenza virus. Unlike some other vaccines, it is made using recombinant technology, which means it is produced without using the actual flu virus. This method can be beneficial for people who have allergies to eggs, as it does not involve egg-based production. The vaccine is designed to help the immune system recognize and fight off the flu virus if exposed.

aQIV is another influenza vaccine that protects against four strains of the flu virus. It is made using a traditional method where the virus is grown in eggs. This vaccine also contains an adjuvant, which is an ingredient that enhances the immune response, making the vaccine more effective. It is particularly useful for older adults, who may need a stronger immune response to be protected against the flu.

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 is characterized by symptoms such as fever, cough, sore throat, runny or stuffy nose, muscle or body aches, headaches, and fatigue. Influenza can lead to mild to severe illness and can sometimes result in complications, especially in certain high-risk groups. The virus spreads mainly through droplets made when people with the flu cough, sneeze, or talk. It can also spread by touching surfaces or objects that have the virus on them and then touching the mouth, nose, or eyes.

Trial ID:
2023-503763-42-00
Protocol code:
V201_03
Trial Phase:
Therapeutic confirmatory (Phase III)

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