Study on the Safety and Immune Response of V116 Vaccine in Children and Adolescents at Higher Risk for Pneumococcal Disease

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What is this study about?

This clinical trial is focused on studying the safety and effectiveness of a new vaccine called V116 in children and adolescents who are at increased risk of developing pneumococcal disease. Pneumococcal disease is an infection caused by the bacteria Streptococcus pneumoniae, which can lead to serious illnesses like pneumonia, meningitis, and bloodstream infections. The study will compare the new vaccine, V116, with an existing vaccine known as Pneumovax® 23, which is also used to prevent pneumococcal disease.

The purpose of the study is to evaluate how safe and well-tolerated the new vaccine is, as well as how well it works in producing an immune response. Participants in the study will receive either the new vaccine, V116, or the existing vaccine, Pneumovax® 23, or a placebo. The study will monitor participants for any side effects and measure their immune response to the vaccine. This will help determine if the new vaccine is as effective or more effective than the existing one.

Participants will be followed for a period of time to observe any reactions to the vaccine and to measure the levels of antibodies, which are proteins in the blood that help fight infections. The study aims to provide valuable information on the potential benefits of the new vaccine for those at higher risk of pneumococcal disease, such as individuals with conditions like diabetes, chronic lung disease, or chronic heart disease. The results of this study could lead to improved prevention strategies for pneumococcal disease in vulnerable populations.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific health conditions such as diabetes, chronic liver, lung, heart, or kidney disease. Stable management of these conditions for at least three months is required.

Participants should not have received more than one dose of the 23-valent pneumococcal vaccine in the last five years.

2 initial vaccination

The first step involves receiving the V116 vaccine. This is administered as a solution for injection into the muscle.

The purpose of this vaccine is to help protect against pneumococcal disease, which can cause serious infections.

3 monitoring for adverse events

After vaccination, monitoring for any adverse events at the injection site or systemic reactions is conducted.

This includes tracking any serious adverse events that may be related to the vaccine.

4 follow-up assessments

Follow-up assessments are conducted to measure the immune response to the vaccine. This involves checking the levels of specific antibodies in the blood.

The assessments help determine the effectiveness of the vaccine in producing an immune response.

5 final evaluation

A final evaluation is conducted to compare the immune response to the V116 vaccine with the response to the previously used 23-valent vaccine.

This includes measuring the geometric mean titers of antibodies and assessing any significant increases from baseline levels.

Who Can Join the Study?

The patient must have one or more of the following risk conditions for pneumococcal disease:
- Diabetes mellitus: A condition where the body has trouble controlling blood sugar levels, and the patient is receiving treatment with medication for diabetes.
- Chronic compensated liver disease: A long-term liver condition where the liver is still able to function.
- Chronic lung disease: A long-term condition affecting the lungs.
- Chronic heart disease: A long-term condition affecting the heart.
- Chronic kidney disease: A long-term condition affecting the kidneys, with ongoing kidney problems.
The patient must be receiving stable medical management for the risk conditions listed above for at least 3 months.
The patient must not have received the pneumococcal vaccine, polyvalent (23-valent) (PPSV23), or must have received no more than 1 dose of PPSV23 at least 5 years before the study vaccination.
The study is open to both male and female participants.

Who Cannot Join the Study?

Individuals who have a known allergy to any component of the vaccine cannot participate. An allergy is when your body reacts negatively to something, causing symptoms like itching or swelling.
People who have had a severe allergic reaction to a previous dose of a pneumococcal vaccine are excluded. A severe allergic reaction can include difficulty breathing or a drop in blood pressure.
Participants with a weakened immune system are not eligible. The immune system is the body’s defense against infections, and if it’s weakened, it may not respond well to the vaccine.
Those who are currently receiving treatment that affects the immune system, such as chemotherapy, cannot join. Chemotherapy is a treatment often used for cancer that can lower the body’s ability to fight infections.
Individuals with a history of certain blood disorders are excluded. Blood disorders can affect how blood cells work, which might impact the vaccine’s effectiveness.
Pregnant women are not allowed to participate. Pregnancy is the period when a woman is carrying a baby, and certain vaccines may not be safe during this time.
People who have received another vaccine within a certain time frame before the study starts are not eligible. This is to ensure that other vaccines do not interfere with the study vaccine.
Anyone with a current illness that includes a fever is excluded. A fever is a temporary increase in body temperature, often due to an infection.
Participants who have been involved in another clinical trial recently are not allowed to join. This is to prevent any overlap that could affect the study results.

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	Tampere	Finland
Centre Hospitalier Universitaire De Lille	Lille	France
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
Region Vaesterbotten	Umea	Sweden
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Robert Debre University Hospital	Paris	France
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
CTC Clinical Trial Consultants AB	Uppsala	Sweden
Pratia S.A.	Skorzewo	Poland
In Vivo Sp. z o.o.	Bydgoszcz	Poland
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Sskvtnenjdi Zqqdti Pgbkzipraai Zjyhavlh Ozcohg Zmymbgpbxh Ift Dvruzk Wsjxnjmb W Deibfjtojdi Lxhvwc	Łomianki	Poland
Hkpebomx Ujiixkwmwv Cdcnjjy Hggottgn	Helsinki	Finland
Gitogsk Dzpewjwncyf I Lxcjyvqw Nuwerlohjuib	Lodz	Poland
Fccsebowf Pgur Lw Ipisbdscixuxf Bgozcfgwv Ddl Hmxwswvp Utyvjyehgrzkm Ly Poy	Madrid	Spain
Hvbsbskx Uuvlfforlwylg Hytbppbf Tqroz y Pakldo Igwbtyaa Cechiz dtyqxjugwsevrozor (htza	Badalona	Spain
Huuutgua Vtlg dagfykwe	Barcelona	Spain
Kkypbuqnn Sfnhqqb Somcytmviapwtoh im Jgyq Prvli Ik	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Finland	Not recruiting	10.01.2024
France	Not recruiting	10.01.2024
Poland	Not recruiting	10.01.2024
Spain	Not recruiting	10.01.2024
Sweden	Not recruiting	10.01.2024

Trial locations

Investigated drugs:

V116 is a vaccine being studied to see how safe and well-tolerated it is in children and adolescents who are at higher risk of getting pneumococcal disease. The trial aims to understand how the body responds to this vaccine and whether it causes any side effects. The study also compares the immune response generated by V116 to that of another vaccine called PPSV23, focusing on specific types of bacteria that can cause pneumococcal disease.

Pneumococcal disease – Pneumococcal disease is an infection caused by the bacterium Streptococcus pneumoniae. It can lead to various illnesses, including pneumonia, meningitis, and bloodstream infections. The disease often begins with symptoms like fever, cough, and difficulty breathing. In some cases, it can progress to more severe conditions, such as inflammation of the brain or spinal cord. The bacteria can spread from person to person through respiratory droplets. It is more common in young children, older adults, and individuals with weakened immune systems.

Trial ID:

2023-506236-32-00

Protocol code:

V116-013

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Immune Response of V116 Vaccine in Children and Adolescents at Higher Risk for Pneumococcal Disease

What is this study about?

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