New meningitis vaccine shows promise in teen trial
NCT ID NCT04490018
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tested a new meningitis vaccine (MenQuadfi) in 463 healthy adolescents aged 10 to 17. It compared the new vaccine to an existing one (Nimenrix) and also checked if it could be given at the same time as HPV and Tdap-IPV vaccines. The goal was to see if the new vaccine provides similar protection against four types of meningococcal bacteria.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Meningococcal vaccine (MenQuadfi)
- What this could lead to
- If successful, this could provide a safe and effective option for protecting adolescents against four types of meningococcal disease, possibly with fewer shots.
- What could go wrong
- This is a completed phase 3 trial, so results are already in. However, the vaccine may not be superior to existing options, and rare side effects can only be fully assessed after wider use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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463 people
The number who actually took part.
- Started
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Mar 2021
- Finished
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May 2022
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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10 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged 10 to 17 years on the day of inclusion ('10 to 17 years' means from the day of the 10th birthday to the day before the 18th birthday). * Meningococcal serogroup C Conjugate vaccine (MenC) naïve participants or participants having received monovalent MenC priming in infancy (less than \[\<\] 2 years of age). * Assent form had been signed and dated by the participant as per local regulation, and Informed Consent Form had been signed and dated by the parent/legally acceptable representative and by the participant if she/he turns 18 years old during the study. * Participants and parent/legally acceptable representative were able to attend all scheduled visits and compiled with all study procedures. * Covered by health insurance, if required by local regulations. Exclusion Criteria: * Participant was pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after last vaccination. To be considered of non-childbearing potential, a female must be pre-menarche. * Previous vaccination against meningococcal disease with either the study vaccine or another vaccine (i.e., polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y; or meningococcal B serogroup-containing vaccine), except licensed monovalent MenC vaccination received before 2 years of age. * Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. * Receipt of any vaccine in the 4 weeks preceding any study vaccination or planned receipt of any vaccine in the 4 weeks following any study vaccination except for influenza vaccination, which might receive at least 2 weeks before study vaccines. This exception included monovalent pandemic influenza vaccines and multivalent influenza vaccines. * History of vaccination with any tetanus, diphtheria, pertussis, or inactivated polio virus vaccine within the previous 3 years. * Previous human papilloma virus (HPV) vaccination. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * History of meningococcal infection, confirmed either clinically, serologically, or microbiologically. * Known history of diphtheria, tetanus, pertussis, poliomyelitis, and/or HPV infection or disease. * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances. * Personal history of Guillain-Barré syndrome. * Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within at least 10 years of the proposed study vaccination. * Personal history of new or past encephalopathy, progressive or unstable neurological disorder, or unstable epilepsy. * Verbal report of thrombocytopenia, contraindicating intramuscular vaccination. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination. * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Current alcohol abuse or drug addiction. * Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion. * Moderate or severe acute illness/infection (according to Investigator's judgment) on the day of vaccination or febrile illness (temperature \>= 38.0 degree Celsius \[\>= 100.4 degree Fahrenheit\]). A prospective participant should not be included in the study until the condition had resolved or the febrile event has subsided. * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw. * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. * Participant at high risk for meningococcal infection during the study (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Investigational Site Number :3480001
Győr, 9024, Hungary
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Investigational Site Number :3480002
Miskolc, 3527, Hungary
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Investigational Site Number :3480003
Budapest, 1042, Hungary
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Investigational Site Number :3480004
Szigetvár, 7900, Hungary
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Investigational Site Number :3480006
Szombathely, 7900, Hungary
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Investigational Site Number :3800001
Genova, IT-16132, Italy
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Investigational Site Number :3800002
Milan, Lombardy, 20154, Italy
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Investigational Site Number :3800004
Palermo, Sicily, 90131, Italy
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Investigational Site Number :3800005
Foggia, Apulia, 71122, Italy
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Investigational Site Number :3800006
Catanzaro, Calabria, 88100, Italy
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Investigational Site Number :7020002
Singapore, 229899, Singapore
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Investigational Site Number :7240001
Seville, Andalusia, 41013, Spain
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Investigational Site Number :7240002
Barcelona, Barcelona [Barcelona], 08035, Spain
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Investigational Site Number :7240003
Madrid, Madrid, Comunidad de, 28007, Spain
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Investigational Site Number :7240004
Valencia, Valenciana, Comunidad, 46020, Spain
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Investigational Site Number :7240005
Esplugues de Llobregat, Castille and León, 08950, Spain
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Investigational Site Number :7240006
Santiago de Compostela, Galicia [Galicia], 15706, Spain
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Investigational Site Number :7240007
Puçol, Valenciana, Comunidad, 46530, Spain
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Investigational Site Number :7240008
Valencia, Valenciana, Comunidad, 46011, Spain
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Investigational Site Number :7240009
Valencia, Valenciana, Comunidad, 46022, Spain
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Investigational Site Number :7240010
Valencia, Valenciana, Comunidad, 46022, Spain
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Investigational Site Number :7240011
Burriana, Valenciana, Comunidad, 12530, Spain
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Investigational Site Number :7240012
Valencia, Valenciana, Comunidad, 46024, Spain
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