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
Al Mare Perearstikeskus OU Tallin Estonia
Rokotetutkimuskeskus Finvac Oy Tampere Finland
Krakowskie Centrum Medyczne Sp. z o.o. Cracow Poland
Berliner Centrum Fur Reise Und Tropenmedizin GmbH Berlin Germany
Kormont Kluisbergen Belgium
Futuremeds Sp. z o.o. Wroclaw Poland

Other Sites

Site Name City Country Status
Diagnostic Consultation Center XX-Sofia EOOD Sofia Bulgaria
Region Stockholm – SLSO Stockholm Sweden
Synexus Clinical Research GmbH Frankfurt Germany
Center for Clinical and Basic Research AS Tallin Estonia
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p. Wroclaw Poland
Klinische Forschung Berlin-Mitte GmbH Berlin Germany
Medif Thuin Belgium
Klinische Forschung Schwerin GmbH Schwerin Germany
BAG Dres. med. Quist PartG Mainz Germany
Studienzentrum Bocholder Straße Essen Germany
Mzaavro Cvyudq Hiuq Edqy Sofia Bulgaria
Pipwhn Reygbjsyqbq Hhxvqi Sdhh Barcelona Spain
Ruicre Shypr Sxvswm Ubqclzsnsepeeqlityo Lund Sweden
Cblpfen Uduirzvpeajwocidtjsb Bbdozx Ktg Berlin Germany
Hqhhrzvz Uvnvwseeqs Cslbusz Hlucsswd Helsinki Finland
Uahavtemscwk Dk Sctspyul Dl Csdckfsdsn Santiago De Compostela Spain
Hjtgytuf Cbdyjnc Sms Cbzhfo Madrid Spain
Hqsazrmi Vuaklx Xbhvl Ikytfjxqjuzjk Benalmadena Spain
Ulswgzevut On Anwsnjv Edegem Belgium
Rndjnj Otedvbu Lpgu Orebro Sweden
Uelkxpwkzrwa Zcfonyofpm Gpeh Gent Belgium
Hwnndngq Utfrkqfukvxex 1z Dw Ozwmvrb Madrid Spain
Hngbwkis Uewfffdptvzpg Dg Lw Pqwjpuwb Madrid Spain
Mcaxxdg Cxffnj Mzqfriasol Pkytfa Obz Pleven Bulgaria
Ets Nuihpbbviubk Sge z ofjs Warsaw Poland
Dpmgjexval Cszlwmqeytxg Csdgzg Abazlhzrs Oed Sofia Bulgaria
Kmaixwsluac Ukugcxslc Kqmuql Om Tartu Estonia
Cnovxlabnl Rjtmrewf sje z obeh Skierniewice Poland
Sipnoontszu Hltijscl Fqy Anuwua Tcszvhcav Om Puuvzvhwzlnfaqifxe Dxjuglef Dnu Tcwklcg Elst Veliko Tirnovo Bulgaria
Mcnykww Coywlm Ddy Mqsjcxpy Exhp Kyustendil Bulgaria
Tykbx Uisgpwbptt Hlbrbeqr Tartu Estonia
Kbqwua Cqnjxm Kvhkhzilg Ssj z ofou Zamosc Poland
Kbghztfbt Fqlgbhixg Btqpvv Gsj Berlin Germany
Zzocdygvgm Owkc Lnlthik Genk Belgium
Mfa Ckucyzks Rcnqzcir Pzlpxmf Bw Pxpxnc Warsaw Poland
Mdkblzt Cdsihw Pvydrj Cuxfxz Euwk Lovech Bulgaria
Ksdjtrqrv Fzqcygbtc Hwmgyrfricbfhe Gswg Hanover Germany
Knwnoszud Fwczjlimv Davoiof Gqxm Dresden Germany
Emmjfex Mechelen Belgium
Kkmqamszk Fnuzxxehw Hmfjddo Ggpc Hamburg Germany
Hjehrgsx Qesrxaihfhs Btjhbqata Barcelona Spain
Mdczchdbcct Ecife Bkezpwc Essen Germany
Plmbrmvciu Namur Belgium
mrbqrtucp Glis Goch Germany
Fllxqwpvt Psuz Er Ftbozut Dr Lu Icrvniodqjnao Sfgbxkegd Y Brsrexxjj Dt Lt Cntzrykrt Vcesxxraxz Valencia Spain
Mlncni Hfxqvd Cazcga Sdxfw Efio Sofia Bulgaria
Zpcfvfa fga kukvnnqtw Fjfstxeha Cologne Germany
Ghibpljkspetggvhanw Mkbjngnatodfn &clljbm Duj Lt Puwafhjbky Tv Diixenqj Stuhr Germany
Phfcgf Dq Mjp Cykxewan Bgqppz Hamburg Germany
Masoncu Cnyrwj Iebtywbnqjt Logf Sofia Bulgaria
Mfftlla Ceeqwx 1 Sxfmbxey Enhw Sevlievo Bulgaria
Viuqhwdq Cyuwfnrd Rvkfilkt Htnovzf Ghof Hamburg Germany
Zurxsgr flf kjbbpwrwq Fcrbbtwcu Akwkcc Olpksfqisfoz Wangen Germany
Fxyenkhykb Geqa Offenbach Am Main Germany
Pflivt Srmb Skorzewo Poland

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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