Study on the Effectiveness and Safety of IVX-A12 Vaccine for Preventing Respiratory Infections in Adults Aged 60 and Older

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What is this study about?

This clinical trial is focused on studying two respiratory diseases: Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (hMPV). These viruses can cause lung infections, especially in older adults. The study will test a new vaccine called IVX-A12, which is designed to protect against both RSV and hMPV. The vaccine is given as a solution for injection into the muscle.

The purpose of the study is to see how well the IVX-A12 vaccine works in preventing lung infections caused by RSV and hMPV in adults aged 60 and older. Participants in the study will receive either the IVX-A12 vaccine or a placebo, which is a substance that looks like the vaccine but does not contain the active ingredients. The study will monitor participants over a period of time to check for any signs of these infections and to assess the safety of the vaccine.

Participants will be followed through different seasons to observe the occurrence of infections. The study aims to gather information on how effective the vaccine is in preventing these infections and to ensure it is safe for use in older adults. This research is important for developing new ways to protect against these common respiratory viruses.

1 initial visit and consent

Upon joining the study, you will attend an initial visit where the study team will explain the trial in detail. You will be asked to sign an informed consent form, confirming your understanding and agreement to participate.

During this visit, your medical history will be reviewed to ensure you meet the study’s eligibility criteria, which includes being 60 years of age or older and medically stable.

2 vaccination

You will receive a single intramuscular injection. This injection will either be the study vaccine, IVX-A12, or a placebo (a saltwater solution). The injection is given in the muscle of your upper arm.

The purpose of the vaccine is to help prevent respiratory illnesses caused by the respiratory syncytial virus (RSV) and human metapneumovirus (hMPV).

3 monitoring period

After the vaccination, you will be monitored for any immediate reactions. This is a standard procedure to ensure your safety.

You will be asked to report any symptoms or health changes you experience during the study period. This helps the study team assess the vaccine’s safety and effectiveness.

4 follow-up visits

You will have scheduled follow-up visits with the study team. These visits are important for monitoring your health and collecting data on the vaccine’s effects.

During these visits, you may undergo physical examinations and provide blood samples. These samples help measure your body’s response to the vaccine.

5 end of study

The study is expected to continue until September 2027. At the end of the study, you will have a final visit to assess your health and discuss your experience.

The information collected during the study will contribute to understanding the vaccine’s ability to prevent illnesses caused by RSV and hMPV.

Who Can Join the Study?

  • Participant must be 60 years of age or older at the time of signing the informed consent.
  • Participants must be medically stable in the opinion of the study doctor. This means that if you have a long-term health condition like diabetes, high blood pressure, or heart disease, it should be under control and not causing major problems.
  • Participants must be able to understand and follow the study requirements. This includes attending all scheduled study visits. If needed, you can have help from a caregiver or a legally authorized representative.

Who Cannot Join the Study?

  • Participants must not have any serious health conditions that could interfere with the study.
  • Participants should not have a history of severe allergic reactions to vaccines.
  • Participants must not be currently participating in another clinical trial.
  • Participants should not have received any other vaccine within 30 days before the study starts.
  • Participants must not have a weakened immune system, which means their body has trouble fighting infections.
  • Participants should not be pregnant or planning to become pregnant during the study.
  • Participants must not have any condition that, in the opinion of the study doctor, makes them unsuitable for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Futuremeds Sp. z o.o. Wroclaw Poland
Krakowskie Centrum Medyczne Sp. z o.o. Cracow Poland
Kormont Kluisbergen Belgium
Berliner Centrum Fur Reise Und Tropenmedizin GmbH Berlin Germany
Hospital Clinico San Carlos Madrid Spain
Rokotetutkimuskeskus Finvac Oy Tampere Finland
Gemeinschaftspraxis Faghih-Friedrichs-Zühlke Essen Germany
Al Mare Perearstikeskus OU Tallin Estonia

Other Sites

Site Name City Country Status
Medical Center Hera EOOD Sofia Bulgaria
Region Oerebro Laen Orebro Sweden
Universitair Ziekenhuis Gent Gent Belgium
Hospital Universitario 12 De Octubre Madrid Spain
Mtz Clinical Research Powered By Pratia Warsaw Poland
FutureMeds GmbH Berlin Germany
Klinische Forschung Hannover-Mitte GmbH Hanover Germany
Klinische Forschung Berlin-Mitte GmbH Berlin Germany
Klinische Forschung Hamburg GmbH Hamburg Germany
Medizentrum Essen Borbeck Essen Germany
Region Stockholm – SLSO Stockholm Sweden
Pneumocare Namur Belgium
Pectus Respiratory Health S.L. Girona Spain
Hospital Quironsalud Barcelona Barcelona Spain
Medif Thuin Belgium
medicoKIT GmbH Goch Germany
Region Skane Skanes Universitetssjukhus Lund Sweden
Etg Neuroscience Sp. z o.o. Warsaw Poland
Diagnostic Consultative Centre Ascendent OOD Sofia Bulgaria
Kliiniliste Uuringute Keskus OÜ Tartu Estonia
Clinmedica Research sp. z o.o. Skierniewice Poland
Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Dr. Treiman EOOD Veliko Tirnovo Bulgaria
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Tartu University Hospital Tartu Estonia
Universidade De Santiago De Compostela Santiago De Compostela Spain
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p. Wroclaw Poland
Pratia S.A. Skorzewo Poland
Ko-Med Centra Kliniczne Sp. z o.o. Zamosc Poland
Diagnostic Consultation Center XX-Sofia EOOD Sofia Bulgaria
Klinische Forschung Berlin GbR Berlin Germany
Hospital Vithas Xanit Internacional Benalmadena Spain
Ziekenhuis Oost Limburg Genk Belgium
HELIOS Kliniken Schwerin GmbH Schwerin Germany
Clinical Research Hamburg GmbH Hamburg Germany
Zentrum für Klinische Forschung Allgäu Oberschwaben Wangen im Allgäu Germany
Synexus Clinical Research GmbH Frankfurt Germany
Medical Center Intermedica Ltd. Sofia Bulgaria
Center for Clinical and Basic Research AS Tallin Estonia
Medical Center 1 Sevlievo EOOD Sevlievo Bulgaria
Htzjqyyz Ucpzsxzcnrkwc Dx Le Pjgkoxdx Madrid Spain
Mswddij Cpbvij Ptuuvv Ccdbke Esrj Lovech Bulgaria
Klflwmvdl Flthnhqxj Dxrelmz Gpeh Dresden Germany
Elducaw Mechelen Belgium
Pqkphr Rpmlkxwyheu Hthtam Shvp Barcelona Spain
Fdmufoucv Pelv En Fqpolaz Dq Lr Itkusprzdritv Stmbvvprn Y Bbbglsfpy Dk Le Cgatnmigy Vuskvpatad Valencia Spain
Umllsqxvub Oq Adhkddj Edegem Belgium
Mfdjnrp Cxxcbh Ddw Mfoyhdai Eslb Kyustendil Bulgaria
Hvroyljj Uidwbtkmhb Cjqchsj Hpudyaas Helsinki Finland
Mnhrfk Hilkfc Cwjxfu Siocn Eyhh Sofia Bulgaria
Zzxwnzu fgt keuccbfvh Fldkbhlwk Cologne Germany
Mnwwnij Ciazzx Mscmsjjpko Pricgf Ozl Pleven Bulgaria
Dtzefmyqbsin Qzgbp Mainz Germany
Gdehfqcqggboaromygp Mavsdnlxwqsri &lpwqli Dkt Lr Pyirnaozdc Tk Dqrfvkqg Stuhr Germany
Pcfloa Dt Mew Coxblfyv Blngxs Hamburg Germany

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
01.09.2025
Bulgaria Bulgaria
Not yet recruiting
01.09.2025
Estonia Estonia
Not yet recruiting
01.09.2025
Finland Finland
Not yet recruiting
01.09.2025
Germany Germany
Not yet recruiting
01.09.2025
Poland Poland
Not yet recruiting
01.09.2025
Spain Spain
Not yet recruiting
01.09.2025
Sweden Sweden
Not yet recruiting
01.09.2025

Trial locations

IVX-A12 is a vaccine designed to protect against two viruses: the Respiratory Syncytial Virus (RSV) and the Human Metapneumovirus (hMPV). These viruses can cause lung infections, especially in older adults. The vaccine works by using particles that look like the viruses to help the body recognize and fight them off if exposed in the future. This study is testing how well the vaccine works, how safe it is, and how the body responds to it in people aged 60 and older.

Respiratory Syncytial Virus Infection – Respiratory Syncytial Virus (RSV) infection is a common respiratory virus that affects the lungs and breathing passages. It typically begins with symptoms similar to a mild cold, such as a runny nose, cough, and fever. As the infection progresses, it can lead to more severe respiratory issues, especially in older adults and those with weakened immune systems. The virus can cause inflammation of the small airways in the lungs, leading to wheezing and difficulty breathing. In some cases, it can progress to bronchiolitis or pneumonia, which are more serious conditions. The infection is highly contagious and spreads through respiratory droplets.

Human Metapneumovirus Infection – Human Metapneumovirus (hMPV) infection is a respiratory virus that causes symptoms similar to those of the common cold. It often starts with a runny nose, cough, and sore throat. As the infection develops, it can lead to more severe respiratory problems, particularly in older adults and individuals with compromised immune systems. The virus can cause inflammation in the airways, resulting in wheezing and difficulty breathing. In some cases, it can lead to bronchiolitis or pneumonia, which are more severe respiratory conditions. The virus is spread through close contact with an infected person or contaminated surfaces.

Trial ID:
2024-513740-28-00
Protocol code:
D8610C00001
Trial Phase:
Therapeutic confirmatory (Phase III)

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