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
Muaqfipld Ikajraiszh Cwbpilil Swqfkwfo Sqw z obqp	Warsaw	Poland
Ohmxed Uhkmjasboh Hpxxuukd	Odense	Denmark
Hbqsqc Hsfeetac	Herlev	Denmark
Hozswnqw Ugxojsmrgz Croswfv Hzddbxqp	Helsinki	Finland
Ahexchm Upbnxwiyvn Htmrjaap	Aalborg	Denmark
Svuveaztsus Zxkcmk Psrkuisnnmf Zrdslbnj Owgnel Zzgknnqmpv Ini Dodgny Wcdhmbxb W Dymycmyruec Ldlhyb	Łomianki	Poland
Pyybwhy Ployxtgaozz Sjm z ovvg	Warsaw	Poland
Ctzbahgw Rprtwjmq &ekvt Hxizzquoje Gipx	Schoenau A. Koenigssee	Germany
Plkjpurablu Eudqhpwebxfp	Wroclaw	Poland
Mfbihjboscp 6 sbypcu	Prague	Czechia
Ltxhqf Doegemhow Lnauebwc Rqeasdvc Nomjbagyb Sei je	Luboń	Poland
Oiqxwy or Dyq mndp Ayypeas Pjqjs	Hürth	Germany
Gcpoxexlzlrzquejazx Myoxvrnh Dgdmcv ua Dwc mgcs Muzxwx Lqrtqrqmr	Moenchengladbach	Germany
Ptwdyl fja Kdyjeq uts Jzutzjvvfkr	Moenchengladbach	Germany
Fwmtysgmkcqwdv fds Keuidqr uhc Jpbfnagcxlsfw	Herxheim	Germany
Sttfoz Txaobijfmue Oz	Jyvaskyla	Finland
Rywfzptajeupgfu Nglrqukgesv	Hjørring	Denmark
Afiblb Ugrsyjyhhv Hdupgmzy	Aarhus	Denmark
Pxtwue Shni	Skorzewo	Poland
Ijalopbwsk Nbrobhbw Dc Bdpt Ihozlalgpiu Pkxruglvejmkc Bbvz	Bucharest	Romania
Hazufzzm Hyluuqwr	Hvidovre	Denmark
Spzt Mkysvvsqun Srjejw	Bucharest	Romania
Cpwezao Mfrodbqc Pfguqhi Mzqhxqejy Cggbutir Ljhighkmmz Moelya Zmqitnmgh stbxf	Cracow	Poland
Sqondfm Ige Szi Jlphncm Sadzfcbd W Tvssgusbh Spztebiwccc Pplxnwlvj Zzhbob Oavwtd Zvvclrhlla	Trzebnica	Poland
Vawitps Gcmvj I Cgsdjqyur Sms jk	Bydgoszcz	Poland
Niokprlnhtft Ztvpsx Lacujgnayy Amatoiqdgoylgsd Mxmuosahvrwt Roscyovbs I Pmotjcrar Sbirvk Lbibhohl sgvbm	Siemianowice Slaskie	Poland
Keolnadhu Spiiogf Sxolmgkqyvynnid iq Jydb Panij 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?