Study on the Safety and Effectiveness of Clesrovimab and Palivizumab for Preventing Severe RSV in Infants and Children at High Risk

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What is this study about?

This clinical trial is focused on studying the prevention of Respiratory Syncytial Virus (RSV) infection in infants and children who are at increased risk for severe RSV disease. RSV is a common virus that can cause serious respiratory illness, especially in young children. The study will compare the safety and effects of a new treatment called Clesrovimab (also known by its code name MK-1654) with an existing medication called Palivizumab. Both treatments are given as a solution for injection.

The purpose of the study is to evaluate how safe and well-tolerated Clesrovimab is compared to Palivizumab during the RSV season. Participants in the study will receive either Clesrovimab, Palivizumab, or a placebo. The study will monitor participants for any side effects, such as reactions at the injection site, fever, or other symptoms. The study will also look at how well the treatments work in preventing RSV-related illnesses that require medical attention or hospitalization.

Participants will be followed through two RSV seasons to gather information on the safety and effectiveness of the treatments. The study aims to provide valuable insights into how these treatments can help protect infants and children from severe RSV disease. The trial will help determine if Clesrovimab is a safe and effective option for preventing RSV infections in this vulnerable population.

1 joining the study

Upon joining the study, the participant will be assessed to ensure they meet the criteria for participation. This includes being at increased risk for severe respiratory syncytial virus (RSV) infection and being within the age range from birth up to 1 year, entering their first RSV season.

2 initial treatment

The participant will receive an injection of either clesrovimab or palivizumab. Both are solutions for injection administered intramuscularly, which means they are injected into a muscle. The specific dosage and frequency will be determined by the study protocol.

3 monitoring and follow-up

Throughout the study, the participant will be monitored for any side effects or adverse events. This includes checking for any reactions at the injection site, changes in body temperature, and any other systemic reactions.

The participant’s health will be closely observed during the RSV season to evaluate the effectiveness of the treatment in preventing severe RSV disease.

4 second RSV season

If applicable, the participant may continue to be monitored during a second RSV season. This includes additional assessments of any side effects and the effectiveness of the treatment.

The participant’s serum concentration of clesrovimab will be measured to understand how the body processes the medication over time.

5 completion of the study

The study is expected to conclude by April 2026. Upon completion, the participant’s overall health and any long-term effects of the treatment will be evaluated.

The participant will be informed of the study’s findings and any relevant information regarding their health and treatment outcomes.

Who Can Join the Study?

Participants must be at increased risk for severe respiratory syncytial virus (RSV) infection. RSV is a virus that can cause lung infections.
Participants should be recommended to receive palivizumab. Palivizumab is a medication given to help prevent RSV infections, based on national or local guidelines or professional society recommendations.
Participants must be available to complete the follow-up period, which means they can attend all required check-ups and assessments during the study.
Participants can be either male or female.
Participants must be from birth up to 1 year old and entering their first RSV season. This means they are experiencing their first time of year when RSV infections are more common.

Who Cannot Join the Study?

Children who have a known allergy to the study medications cannot participate.
Children who have participated in another clinical trial within the last 30 days are not eligible.
Children with a history of severe allergic reactions to any medication are excluded.
Children who have received any other investigational drug within the last 30 days cannot join the study.
Children with any condition that the study doctors believe would make it unsafe for them to participate are not allowed to join.
Children who have a serious illness that requires ongoing medical treatment may not be eligible.
Children who have a weakened immune system, which means their body has a harder time fighting infections, are excluded.
Children who have received a blood transfusion or blood products within the last 3 months cannot participate.
Children who have a history of lung disease or heart disease that is not well controlled are not eligible.
Children who are currently taking medications that affect the immune system are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Rokotetutkimuskeskus Finvac Oy	Kokkola	Finland
FVR Suomen rokotetutkimus Oy	Oulu	Finland
FVR Suomen rokotetutkimus Oy	Seinajoki	Finland
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Rokotetutkimuskeskus Finvac Oy	Tampere	Finland
Universitaet Leipzig	Leipzig	Germany
Technische Universitaet Dresden	Dresden	Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Oslo Universitetssykehus HF	Oslo	Norway
Medizinische Hochschule Hannover	Hanover	Germany

Other Sites

Site Name	City	Country
Azienda Ospedaliera di Padova	Padua	Italy
Fakultni Nemocnice Brno	Brno	Czechia
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz	Miskolc	Hungary
Athens General Children’s Hospital Panagioti And Aglaia Kyriakou	Athens	Greece
Hippokration Hospital	Athens	Greece
Centre Hospitalier De Versailles	Le Chesnay-Rocquencourt	France
Hospital Universitari General De Catalunya	Sant Cugat Del Valles	Spain
University Of Debrecen	Debrecen	Hungary
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz	Nyiregyhaza	Hungary
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Semmelweis University	Budapest	Hungary
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Nosokomeio Paidon I Agia Sofia	Athens	Greece
Bajai Szent Rokus Korhaz	Baja	Hungary
Gottsegen National Cardiovascular Center	Budapest	Hungary
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
University Hospital Ostrava	Ostrava	Czechia
Hospital Universitario Hm Monteprincipe	Boadilla Del Monte	Spain
The Institute For The Care Of Mother And Child	Prague	Czechia
Ptuwxgm Shohlm Urndd Knttzq Rsmuseoebqpjuu	Budapest	Hungary
Bbzlymlaxch Vcbpnictt Ouysvnqmwcxr	Kecskemet	Hungary
Fyy Sdvjzt rpbaalpipauyzw Ow	Turku	Finland
Hlrljrdb Ujpxltznhl Cemimli Hvvlxfkl	Helsinki	Finland
Aadhytg Otitekaiueh Ujjpkdtpgrtnr Pnlti	Parma	Italy
Fpeximmol Pnnk Ll Ilnirfuweljuy Bcaiemrwq Dut Hfxyfduj Uicvymktujowr Lx Pjq	Madrid	Spain
Hubihlvr Uafapraotmzah Hmokfpvc Tbavd y Pmnqgt Izwhedpl Cttjwf dwpuqheaemhfjzzeh (xpfm	Badalona	Spain
Uqwawzejvl Gcjmmea Hyevndgy Acoocwg	Athens	Greece

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	30.11.2021
Finland	Not recruiting	30.11.2021
France	Not recruiting	30.11.2021
Germany	Not recruiting	30.11.2021
Greece	Not recruiting	30.11.2021
Hungary	Not recruiting	30.11.2021
Italy	Not recruiting	30.11.2021
Norway	Not recruiting	30.11.2021
Spain	Not recruiting	30.11.2021

Trial locations

Investigated drugs:

Clesrovimab (MK-1654) is a medication being studied to see how safe and effective it is for infants and children who are at higher risk of getting severe respiratory syncytial virus (RSV) disease. RSV is a virus that can cause serious lung infections, especially in young children. This medication is designed to help protect against RSV by boosting the body’s ability to fight off the virus.

Palivizumab is a medication that is already used to help prevent serious RSV infections in children who are at high risk. It works by providing antibodies that help the body fight off the RSV virus. In this study, palivizumab is used as a comparison to see how well the new medication, clesrovimab, works in protecting children from RSV.

Respiratory Syncytial Virus Infection – Respiratory Syncytial Virus (RSV) infection is a common respiratory virus that usually causes mild, cold-like symptoms. It primarily affects the respiratory tract, including the nose, throat, and lungs. In infants and young children, RSV can lead to more severe respiratory illnesses such as bronchiolitis and pneumonia. The virus spreads through respiratory droplets when an infected person coughs or sneezes. Symptoms typically appear 4 to 6 days after exposure and can include runny nose, decrease in appetite, coughing, sneezing, fever, and wheezing. The infection usually resolves within one to two weeks, but in some cases, it can lead to more serious respiratory issues, especially in young children and those with weakened immune systems.

Trial ID:

2022-500752-39-00

Protocol code:

MK-1654-007

NCT ID:

NCT04938830

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Effectiveness of Clesrovimab and Palivizumab for Preventing Severe RSV in Infants and Children at High Risk

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?