Study on the Safety and Immune Response of a 21-Valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers

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What is this study about?

This clinical trial is focused on studying a vaccine for preventing infections caused by the bacteria *Streptococcus pneumoniae*, commonly known as pneumococcal disease. This disease can lead to serious infections like pneumonia, meningitis, and bloodstream infections, especially in young children. The study will compare two vaccines: a new 21-valent *Pneumococcal Conjugate Vaccine (PCV21)* and an existing 15-valent vaccine called *Vaxneuvance*. The term “valent” refers to the number of different types of bacteria the vaccine can protect against. The purpose of the study is to see if the new vaccine is as effective or better than the existing one in producing a strong immune response in infants and toddlers.

Participants in the study will receive either the new *PCV21* vaccine or the *Vaxneuvance* vaccine. The vaccines are given as a series of injections into the muscle. The study will monitor the immune response by measuring the levels of antibodies, which are proteins the body makes to fight infections. The study will also check for any side effects or reactions to the vaccines. The goal is to ensure that the new vaccine is safe and effective for young children.

The study will last for several months, with follow-up visits to check the health and immune response of the participants. The researchers will look at how well the vaccines work against the different types of pneumococcal bacteria included in the vaccines. This information will help determine if the new vaccine can provide better protection against pneumococcal disease in children. The study will also track any immediate or long-term side effects to ensure the safety of the vaccines.

1 joining the study

Upon joining the study, the participant will be assessed to ensure they meet the eligibility criteria. This includes being between 42 to 112 days old, being healthy as determined by a medical evaluation, and having been born at full term or after a gestation period above 28 weeks with a medically stable condition.

2 first vaccination

The participant will receive the first dose of the pneumococcal conjugate vaccine (PCV) through an intramuscular injection. This vaccine is designed to help protect against infections caused by pneumococcal bacteria.

3 monitoring after first vaccination

After the first vaccination, the participant will be monitored for any immediate adverse events. This includes checking for any reactions at the injection site or any systemic reactions for up to 7 days after the injection.

4 subsequent vaccinations

The participant will receive additional doses of the vaccine at specified intervals. The exact schedule will be provided by the study team. Each dose will be administered via intramuscular injection.

5 monitoring after each vaccination

Following each vaccination, the participant will be observed for any immediate adverse events. Monitoring will continue for 7 days to check for any injection site or systemic reactions. Any unsolicited reactions will be recorded for 30 days after each injection.

6 final assessment

At the end of the study period, a final assessment will be conducted to evaluate the participant’s antibody response to the vaccine. This will involve measuring the levels of specific antibodies in the blood.

7 long-term follow-up

The participant will be monitored for any serious adverse events or adverse events of special interest for up to 6 months after the last vaccine injection.

Who Can Join the Study?

Aged between 42 to 112 days on the day of joining the study.
Must be healthy, as determined by a medical check-up, which includes reviewing medical history and a physical examination.
Born at full term of pregnancy, which means 37 weeks or more, with a birth weight of at least 2.5 kg (about 5.5 pounds).
Or, born after a pregnancy period of more than 28 weeks but less than 37 weeks, with a birth weight of at least 1.5 kg (about 3.3 pounds), and in both cases, must be medically stable as assessed by the doctor.

Who Cannot Join the Study?

Patients who have received any other pneumococcal vaccine before the study cannot participate. A pneumococcal vaccine is a shot that helps protect against infections caused by the bacteria called pneumococcus.
Patients with a known allergy to any component of the study vaccine cannot participate. An allergy is when your body reacts badly to something that is usually harmless.
Patients with a history of severe allergic reactions, such as anaphylaxis, cannot participate. Anaphylaxis is a serious and life-threatening allergic reaction that happens quickly and needs immediate medical attention.
Patients with a known or suspected problem with their immune system cannot participate. The immune system is the body’s defense against infections and illnesses.
Patients who have received blood products or immunoglobulins within the last 3 months cannot participate. Blood products and immunoglobulins are treatments that can affect the immune system.
Patients with a serious chronic illness that could interfere with the study cannot participate. A chronic illness is a long-lasting health condition that may not go away.
Patients who are currently participating in another clinical trial cannot participate. A clinical trial is a research study to test new treatments or procedures.
Patients who have received any other vaccine within 14 days before the study vaccine cannot participate. Vaccines are shots that help protect against diseases.
Patients with a fever or acute illness at the time of vaccination cannot participate. A fever is a higher-than-normal body temperature, and an acute illness is a sudden and severe sickness.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Pediatrie Slunicko s.r.o.	Prague	Czechia
Kinderarztpraxis Leyental	Krefeld	Germany
Rokotetutkimuskeskus Finvac Oy	Tampere	Finland
Universitaet Leipzig	Leipzig	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Detska doktorka Plzen s.r.o.	Plzen	Czechia
Al Mare Perearstikeskus OU	Tallin	Estonia
Vee Perearstikeskus OÜ	Paide	Estonia
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
ASST Fatebenefratelli Sacco	Milan	Italy
Azienda Ospedaliera Universitaria Meyer IRCCS	Florence	Italy
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Nosokomeio Paidon I Agia Sofia	Athens	Greece
University General Hospital Of Heraklion	Heraklion	Greece
Evangelisches Krankenhaus Duesseldorf	Duesseldorf	Germany
GPR Gesundheits und Pflegezentrum Ruesselsheim gGmbH	Ruesselsheim Am Main	Germany
Medif	Thuin	Belgium
Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Rybarczyk I Partnerzy Spolka Lekarska sp.p.	Siemianowice Slaskie	Poland
Athens General Children’s Hospital Panagioti And Aglaia Kyriakou	Athens	Greece
Hippokration Hospital	Athens	Greece
Jagiellońskie Centrum Innowacji Sp. z o.o.	Cracow	Poland
Kliiniliste Uuringute Keskus OÜ	Tartu	Estonia
University General Hospital Of Ioannina	Ioannina	Greece
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
General University Hospital Of Patras	Patras	Greece
In Vivo Sp. z o.o.	Bydgoszcz	Poland
Anima	Alken	Belgium
Spaarne Gasthuis	Hoofddorp	The Netherlands
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara	Chaidari	Greece
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari	Bari	Italy
MUDr. Daniela Verdánová, MBA	Jindřichův Hradec	Czechia
WeMaMed -c/o Prax. für Kinder- und Jugendmedizin	Wolfsburg	Germany
Office of Dr. med. Andreas Petri	Hürth	Germany
Kinder- und Jugendärzte Hürth-Park, Dr. med. Ludwig Stapenhorst	Hürth	Germany
Cyqjlzfd Rjmewpsm &wmsp Hvsejxtrkt Ghgj	Schoenau A. Koenigssee	Germany
Ahlvkar Ozboxxongrw Uzgawufondzll Pkxbp	Parma	Italy
Ufrhhneqca Dkxty Scrud Do Rfqw Lo Snxwxyay	Rome	Italy
Abslwqa Scweesfaq Luybze Dngsm Pypnvrvzu Dz Lqiwf	Lecce	Italy
Mkhec Lmlyzkr Stdkocar smkbge	Krnov	Czechia
Fydwapvytjnwnj fal Kunjbxd uzt Jkriqlpwlsnsf	Herxheim	Germany
Shbybqrzvlp Znwdjt Pxvorkklidd Zerkwrhi Omkuuy Zjnqlhpfwy Ign Dondlk Wfmeroct W Dbvwtjmpwta Lkqjfv	Łomianki	Poland
Pltyaec Pqdvsxwlxtj Svn z ohco	Warsaw	Poland
Muklzuqu Hauktvhf	Helsinki	Finland
Scgimxt Iii Ssh Jbucfbp Skrbwqdv W Tmqgfjwuo Szxojajfnhh Pezdkuqtz Zrlymg Oxouta Zmlokvegjk	Trzebnica	Poland
Modqjwiig Ijcltairtm Cokpfxji Slwcztzy Sgu z oceq	Warsaw	Poland
Aapryfn Oifftikzeuf Uidxkirpevrxq Oussuvuv Rewezbk	Foggia	Italy
Unftcatbqw Oj Afqwyei	Edegem	Belgium
Peeces kzqnwliycikzt	Moenchengladbach	Germany
Gqkcvwvzxggofwvzlpb Mowuxupa Dwxjlb uz Dif mayz Mrikqq Lxnhveclc	Moenchengladbach	Germany

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	16.05.2025
Czechia	Not recruiting	16.05.2025
Estonia	Not recruiting	16.05.2025
Finland	Not recruiting	16.05.2025
Germany	Not recruiting	16.05.2025
Greece	Not recruiting	16.05.2025
Italy	Not recruiting	16.05.2025
Poland	Not recruiting	16.05.2025
The Netherlands	Not recruiting	16.05.2025

Trial locations

Investigated drugs:

PCV21 is a 21-valent pneumococcal conjugate vaccine. This vaccine is designed to protect against 21 different types of the bacteria that can cause pneumococcal disease. Pneumococcal disease can lead to serious infections like pneumonia, meningitis, and bloodstream infections. The vaccine works by helping the body’s immune system recognize and fight these bacteria, reducing the risk of getting sick from them. In this trial, PCV21 is being tested to see how well it works in producing an immune response in healthy infants and toddlers.

15vPCV is a 15-valent pneumococcal conjugate vaccine. Similar to PCV21, this vaccine is designed to protect against 15 different types of the bacteria that cause pneumococcal disease. It helps the immune system to recognize and combat these bacteria, aiming to prevent serious infections. In the trial, 15vPCV is used as a comparison to evaluate the effectiveness of the new PCV21 vaccine in generating an immune response in young children.

Pneumococcal Disease – Pneumococcal disease is caused by the bacterium Streptococcus pneumoniae, which can lead to infections in different parts of the body. It often begins with symptoms similar to a cold, such as a runny nose, cough, and fever. As it progresses, it can cause more severe conditions like pneumonia, meningitis, or bloodstream infections. The bacteria can spread from person to person through respiratory droplets. Infections can occur in the lungs, brain, or blood, leading to inflammation and other complications. The severity of the disease can vary depending on the site of infection and the individual’s immune response.

Trial ID:

2023-507600-32-00

Protocol code:

PSK04

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Immune Response of a 21-Valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?