Study on the Safety and Immune Response of MenACYW Conjugate Vaccine Compared to a Drug Combination in Healthy Infants and Toddlers

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of a vaccine for preventing meningococcal infection in healthy infants and toddlers. Meningococcal infection is a serious illness caused by bacteria that can lead to infections in the brain and spinal cord. The study involves two vaccines: the MenQuadfi vaccine and the Nimenrix vaccine. Both vaccines are designed to protect against four groups of the bacteria: A, C, W, and Y. The purpose of the study is to compare the immune response generated by these vaccines when given to infants at 6 months and again at 12 months.

Participants in the study will receive two doses of either the MenQuadfi vaccine or the Nimenrix vaccine. The first dose will be administered when the infants are between 6 and 7 months old, and the second dose will be given when they are between 12 and 13 months old. The study will monitor the levels of antibodies, which are proteins in the blood that help fight infections, to see how well the vaccines work. The study will also track any side effects or reactions to the vaccines to ensure they are safe for use in young children.

The trial aims to demonstrate that the MenQuadfi vaccine is not less effective than the Nimenrix vaccine in producing an immune response. This will be measured by looking at the levels of antibodies in the blood after vaccination. The study will also observe any immediate or delayed reactions to the vaccines, including any serious adverse events. The results of this study will help determine the best vaccination strategy for protecting young children against meningococcal infection.

1 initial visit and first vaccination

Upon joining the study, the first step involves an initial visit. During this visit, a healthcare professional will conduct a medical evaluation, which includes reviewing medical history and performing a physical examination to ensure eligibility.

If eligible, the first dose of the MenACYW conjugate vaccine or Nimenrix will be administered. This vaccine is given as an intramuscular injection, which means it is injected into a muscle. The first dose is given when the infant is between 6 to 7 months old.

2 monitoring after first vaccination

After the first vaccination, there will be a period of monitoring to observe any immediate reactions to the vaccine. This is to ensure the safety and well-being of the participant.

Participants may be asked to report any side effects or reactions experienced after the vaccination. This information is important for assessing the safety of the vaccine.

3 second visit and second vaccination

The second visit occurs when the participant is between 12 to 13 months old. During this visit, the second dose of the vaccine will be administered.

Similar to the first dose, the second dose is also given as an intramuscular injection. This completes the 2-dose series of the vaccine.

4 monitoring after second vaccination

Following the second vaccination, there will be another period of monitoring to check for any immediate reactions.

Participants will again be asked to report any side effects or reactions. This helps in understanding the safety profile of the vaccine.

5 follow-up and study completion

After the second vaccination and monitoring period, there may be follow-up visits or communications to gather additional information about the participant’s health and any long-term effects of the vaccine.

The study is expected to continue until August 2025, and participants will be informed about the completion of the study and any findings that are relevant to their health.

Who Can Join the Study?

Aged 6 to 7 months on the day of inclusion
Participants who are healthy as determined by medical evaluation, including medical history, physical examination, and judgment of the Investigator (the doctor or medical professional in charge of the study)

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, especially to vaccines.
Participants must not have received any other vaccines within a certain period before the study starts.
Participants should not be taking medications that could affect the immune system, such as steroids.
Participants must not have any known or suspected immune system disorders.
Participants should not have any ongoing infections or illnesses at the time of the study.
Participants must not have participated in another clinical trial recently.
Participants should not have any conditions that the study doctors believe would make participation unsafe.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Eivy Franke Beckmann	Erfurt	Germany
Kinderaerztliche Gemeinschaftspraxis Wolfsburg	Wolfsburg	Germany
MUDr. David Zeman s.r.o.	Poruba	Czechia
Sanare s.r.o.	Ceske Budejovice	Czechia
MUDr.Natasa Guklhornova s.r.o.	Ceske Budejovice	Czechia
Przylądek Zdrowia	Cracow	Poland
Centrum Medyczne Ad-Med Sp. z o.o.	Wroclaw	Poland
Silver Medica	Janki	Poland
Kinderarztpraxis Dr. med. Siegfried Simmet + Simon Traub in Berufsausübungsgemeinschaft	Schweigen-Rechtenbach	Germany
Kinderarztpraxis Dr Kaiser – Dr. Marinesse	Hamburg	Germany
Med Fam Apolo S.R.L.	Călărași	Romania
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Szpital Bielanski Im.Ks.Jerzego Popieluszki samodzielny publiczny zakład opieki zdrowotnej	Warsaw	Poland
Spitalul Clinic De Urgenta Pentru Copii Brasov	Brasov	Romania
Rokotetutkimuskeskus Finvac Oy	Tampere	Finland
Niepubliczny Zaklad Opieki Zdrowotnej Salmed	Leczna	Poland
Nemocnice Pardubickeho kraje a.s.	Pardubice	Czechia

Other Sites

Site Name	City	Country
Jagiellońskie Centrum Innowacji Sp. z o.o.	Cracow	Poland
Klinikum Worms gGmbH	Worms	Germany
In Vivo Sp. z o.o.	Bydgoszcz	Poland
Mzlutrrut Ikilceslfd Ctdgamfy Shkcdymb Scb z oyvb	Warsaw	Poland
Oxummd Upgzqtwdzu Hpkdvosy	Odense	Denmark
Hypocl Hawpjsxk	Herlev	Denmark
Hjxbhekp Uutnpkolas Cqrocsg Hlftuclx	Helsinki	Finland
Aigpdix Ukqlbrngxo Hyhkddhs	Aalborg	Denmark
Sywehmgtiok Zvhhmk Pexxjkpepyr Zieymyun Otvwqo Zvrmscfzmu Ihm Debabe Wiabbtfj W Dxojuuqnozq Lywfvd	Łomianki	Poland
Ppdklpa Pwnzkoqboai Snt z okcq	Warsaw	Poland
Crmeintp Rdgaciud &avaq Hgolondpch Gvfo	Schoenau A. Koenigssee	Germany
Pjcwammoxzw Edpxqcuqhhdk	Wroclaw	Poland
Mhctorejuso 6 sfmmqm	Prague	Czechia
Lxuvvu Dnwuumtqm Lwnunqti Reflkblc Nifunsqhv Sjl jt	Luboń	Poland
Ouhdtq og Dqd mhfx Aivvkjb Pyjmo	Hürth	Germany
Gjdmvybxgvzbnoxljoi Mqlfswoz Deynwp uz Dek mwzi Mjkzzc Lbegmqtvf	Moenchengladbach	Germany
Pbtnep fef Khoaon udw Jtqakeyoafl	Moenchengladbach	Germany
Fjyrrcvzlfajqj fmz Kqrwqcn uyl Jwnomydgyfbfm	Herxheim	Germany
Sypltb Tvpkihhxcgn Og	Jyvaskyla	Finland
Rrhewvbhpihcxml Naxifrgjccx	Hjørring	Denmark
Akiakp Uecposzxlb Hlfvpiqy	Aarhus	Denmark
Pupqrg Sagb	Skorzewo	Poland
Itiecjedcz Nmwhpjmx Dh Bwvc Ilsfxrbqrrp Poneewnafiqen Bgtt	Bucharest	Romania
Hupmkvwm Hjauboep	Hvidovre	Denmark
Skbp Mwshcbqxsm Sxpogt	Bucharest	Romania
Ckvabgz Mmpaygqo Pmzfhry Mkjvnmncq Cowsicqf Locozzewpx Muasib Zbixgqrlp sclfs	Cracow	Poland
Smjigdy Ira Sre Jaypezl Spbwiqwx W Thtoapiyc Scqpqjknade Pvollgvla Zrhhla Omhhel Zcbifcywdb	Trzebnica	Poland
Vhdkkrf Gmtkm I Cphygzvjw Smj jp	Bydgoszcz	Poland
Ncslpvcwylyh Zjhrcp Luyagunvck Apeuuwcvckiaqwa Mehzdlreecgt Rutksxexd I Plsfjavod Seqsbf Lpesqxaa scsxd	Siemianowice Slaskie	Poland
Kqxxozqwf Swuyjiz Shkeasuhkthnicq iq Juoy Psrgd Ih	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	19.02.2024
Denmark	Not recruiting	19.02.2024
Finland	Not recruiting	19.02.2024
Germany	Not recruiting	19.02.2024
Poland	Not recruiting	19.02.2024
Romania	Not recruiting	19.02.2024

Trial locations

Investigated Drugs:

MenACYW conjugate vaccine is a vaccine designed to protect against four types of bacteria that can cause meningitis, which are known as serogroups A, C, W, and Y. This vaccine works by helping the body build immunity against these bacteria, reducing the risk of developing meningitis. In this clinical trial, the vaccine is given to infants and toddlers in two doses, one at 6-7 months and another at 12-13 months, to see how well it works and how safe it is for young children.

Nimenrix® is another vaccine that also protects against the same four types of bacteria that can cause meningitis: serogroups A, C, W, and Y. Like the MenACYW conjugate vaccine, it helps the body develop immunity to these bacteria. In this study, Nimenrix® is used as a comparison to see if the MenACYW conjugate vaccine is just as effective and safe when given to infants and toddlers at the same ages and intervals.

Investigated Diseases:

Meningococcal infection

Meningococcal Infection – Meningococcal infection is caused by the bacterium Neisseria meningitidis, which can lead to serious illnesses such as meningitis and septicemia. The bacteria are transmitted through respiratory droplets and can colonize the nasopharynx. In some cases, the bacteria invade the bloodstream and spread to the brain and spinal cord, causing inflammation of the protective membranes. Symptoms may include sudden fever, headache, stiff neck, nausea, vomiting, increased sensitivity to light, and confusion. The disease can progress rapidly, and early symptoms may resemble those of the flu. It is important to monitor for any signs of severe illness, especially in young children and infants.

Trial ID:

2023-508177-85-00

Protocol code:

MEQ00089

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Immune Response of MenACYW Conjugate Vaccine Compared to a Drug Combination in Healthy Infants and Toddlers

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?