Study on the Safety and Immune Response of MenABCWY Vaccine and Drug Combination in Healthy Infants with Meningococcal Infections

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What is this study about?

This clinical trial is focused on studying a disease called meningococcal infection, which is caused by bacteria that can lead to serious illnesses like meningitis. The study is testing a new vaccine called MenABCWY, which is designed to protect against several groups of the bacteria that cause these infections. The trial will also involve other vaccines, including MenB and MenACWY-TT, to compare their effectiveness and safety. The purpose of the study is to evaluate how safe these vaccines are and how well they work in producing an immune response in healthy infants.

Participants in the study will receive the vaccines as injections. The study will monitor the infants over a period of time to observe any reactions to the vaccines and to measure the immune response. This will help determine how well the vaccines protect against the different groups of the bacteria. The study will also include a comparison with a placebo to ensure the results are accurate.

The trial will take place over several months, with multiple visits for vaccinations and follow-up checks. The researchers will collect data on any side effects and the overall health of the participants. This information will be used to assess the safety and effectiveness of the vaccines in preventing meningococcal infection in infants. The study aims to provide valuable insights into the best ways to protect against this serious disease.

1 joining the study

Upon joining the study, the participant’s parent or legally acceptable representative provides written or witnessed consent. This consent is necessary before any study-specific procedures begin.

The participant is confirmed to be healthy through a medical history review and clinical examination.

2 first vaccination

The participant receives the first dose of the MenABCWY-2nd Gen vaccine or another study vaccine. This is administered as an injection.

The participant is monitored for any immediate reactions to the vaccine.

3 monitoring after first vaccination

For 7 days following the first vaccination, the participant is observed for any local or systemic reactions at the injection site.

For 30 days after the vaccination, any unexpected adverse events, including those requiring medical attention, are recorded.

4 second vaccination

The participant receives a second dose of the study vaccine approximately 91 days after the first vaccination.

The participant is again monitored for any immediate reactions to the vaccine.

5 monitoring after second vaccination

For 7 days following the second vaccination, the participant is observed for any local or systemic reactions at the injection site.

For 30 days after the vaccination, any unexpected adverse events, including those requiring medical attention, are recorded.

6 third vaccination

The participant receives a third dose of the study vaccine approximately 301 days after the first vaccination.

The participant is monitored for any immediate reactions to the vaccine.

7 monitoring after third vaccination

For 7 days following the third vaccination, the participant is observed for any local or systemic reactions at the injection site.

For 30 days after the vaccination, any unexpected adverse events, including those requiring medical attention, are recorded.

8 final assessment

The participant’s immune response to the vaccines is assessed through blood tests conducted at specified intervals.

The study concludes with a final assessment of the participant’s health and any long-term effects of the vaccinations.

Who Can Join the Study?

The participant’s parent(s) or Legally Acceptable Representative(s) (LAR(s)) must be able and willing to follow the study requirements, as judged by the study doctor.
Written or witnessed/thumb printed informed consent must be obtained from the parent(s) or LAR(s) before any study-specific procedures are done. Informed consent means they agree to the participant being in the study after understanding all the details.
The participant must be healthy, as determined by their medical history and a physical examination before joining the study.
The participant must be a male or female who is between 55 and 89 days old (about 2 months old) at the time of the first study vaccination.
The participant must have been born after a pregnancy lasting at least 37 weeks and must have had a birth weight of at least 2.5 kg.

Who Cannot Join the Study?

Patients with any current or past infections caused by meningococcal bacteria cannot participate. Meningococcal bacteria can cause serious illnesses like meningitis.
Patients who have received any meningococcal vaccines in the past cannot participate. These vaccines are used to protect against infections caused by meningococcal bacteria.
Patients with any known allergies to the components of the study vaccines cannot participate. An allergy is when your body reacts negatively to a substance.
Patients with any immune system disorders cannot participate. The immune system is the body’s defense against infections and diseases.
Patients who are currently participating in another clinical trial cannot participate. A clinical trial is a research study to test new treatments.
Patients who are pregnant or breastfeeding cannot participate. Pregnancy is the period when a woman carries a developing fetus, and breastfeeding is feeding a baby with milk from the breast.
Patients with any serious chronic illnesses cannot participate. Chronic illnesses are long-lasting health conditions that require ongoing medical attention.
Patients who have received any blood products in the past 3 months cannot participate. Blood products are components derived from blood, like plasma or red blood cells.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Przylądek Zdrowia	Cracow	Poland
Hospital Clinico San Carlos	Madrid	Spain
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Instituto Hispalense De Pediatria S.L.	Sevilla	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Rybarczyk I Partnerzy Spolka Lekarska sp.p.	Siemianowice Slaskie	Poland
Hospital Quironsalud Malaga	Malaga	Spain
Jagiellońskie Centrum Innowacji Sp. z o.o.	Cracow	Poland
Virgen del Rocío University Hospital	Sevilla	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
In Vivo Sp. z o.o.	Bydgoszcz	Poland
Area De Salud De Burgos Y Soria	Burgos	Spain
Hospital Costa del Sol	Marbella	Spain
Cphmvzot Rgncerhi &mmuz Hytchnwvor Gozr	Schoenau A. Koenigssee	Germany
Pxmwixwd Mds Gjlz Gfodxkvjbgcagzjv fwek Kpmhor uul Juvhlhxgygokc	Gilching	Germany
Lydkpq Detmvxemo Lzddyqak Ryejtusv Nernalzho Smc ju	Luboń	Poland
Pegokkt Prctyjzuiqj Sim z oulk	Warsaw	Poland
Samudgd Ivi Sky Jfgymul Sphyowae W Tlbgqxocu Sldtchtodfi Pfllmosjr Zveyki Oopqyo Zrxoimvmql	Trzebnica	Poland
Mptvljrwt Iwqiawpapz Cygrtbxa Sodowyqx Sgy z omgw	Warsaw	Poland
Ftcgbeuzx Pxsu Lg Ifvmejmdkuwhq Bfjplpxon Dro Hssmdwqt Urrnsjlwuxtgx Lb Pvb	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	03.12.2021
Poland	Not recruiting	03.12.2021
Spain	Not recruiting	03.12.2021

Trial locations

Investigated drugs:

MenABCWY-2nd Gen vaccine is a new version of a vaccine designed to protect against meningococcal disease, which is a serious infection caused by bacteria. This vaccine targets multiple strains of the bacteria, specifically serogroups A, B, C, W, and Y. The goal of this vaccine is to help the body build immunity, which means it trains the immune system to recognize and fight off these bacteria if they are encountered in the future.

MenABCWY-1st Gen vaccine is an earlier version of the meningococcal vaccine that also aims to protect against the same serogroups: A, B, C, W, and Y. Like the 2nd Gen version, it helps the immune system learn how to defend against these bacteria, reducing the risk of developing meningococcal disease.

MenB vaccine is specifically designed to protect against serogroup B of the meningococcal bacteria. This vaccine helps the immune system recognize and fight off this particular strain, which is one of the causes of meningococcal disease.

MenACWY-TT vaccine is another type of meningococcal vaccine that targets serogroups A, C, W, and Y. It works by helping the immune system prepare to fight these specific strains of bacteria, thereby reducing the risk of infection and serious illness.

Meningococcal Infections – Meningococcal infections are caused by the bacterium Neisseria meningitidis. These infections can lead to serious conditions such as meningitis, which is the inflammation of the protective membranes covering the brain and spinal cord. The disease often begins with symptoms like sudden fever, headache, and a stiff neck. As it progresses, individuals may experience nausea, vomiting, increased sensitivity to light, and confusion. The bacteria can also cause bloodstream infections, leading to symptoms such as fatigue, cold hands and feet, chills, severe aches or pain in the muscles, joints, chest, or abdomen, and a rapid breathing rate. If not addressed, the infection can spread rapidly, affecting multiple organs.

Trial ID:

2023-506449-40-00

Protocol code:

217043

NCT ID:

NCT05082285

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Immune Response of MenABCWY Vaccine and Drug Combination in Healthy Infants with Meningococcal Infections

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?