New quadrivalent meningitis vaccine aims to shield China's youngest from deadly infection
NCT ID NCT07710872
First seen Jul 17, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This phase 3 study tests an investigational meningococcal conjugate vaccine in healthy infants and toddlers aged 2 to 23 months in China. The vaccine targets four serogroups of meningococcal bacteria (A, C, W, Y) that can cause meningitis and bloodstream infections. Researchers compare the new vaccine's safety and immune response to locally licensed vaccines, with participants receiving multiple doses and follow-up over several months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an investigational quadrivalent meningococcal conjugate vaccine (MenACYW conjugate vaccine)
- What this could lead to
- If successful, this vaccine could help protect infants and toddlers in China against four common types of meningococcal bacteria that cause serious infections like meningitis.
- What could go wrong
- This is a phase 3 trial, but results may differ in real-world use. The vaccine's effectiveness and safety are still being confirmed, and side effects like injection site reactions or fever are possible.
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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About 4,568 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- 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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2 to 23 months
- 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: * For Cohort I: Aged 12 months through 23 months on the day of inclusion. For Cohort II: Aged 6 months through 11 months on the day of inclusion. For Cohort III: Aged 2 months through 5 months on the day of inclusion * Born at full term of pregnancy (≥37 weeks) or born after a gestation period of 27 through 36 weeks and medically stable as assessed by the investigator * Informed consent form has been signed and dated by the parent(s) or other LAR (and by an independent witness if required by local regulations). * Participant and parent/LAR are able to attend all scheduled visits and to comply with all study procedures. Exclusion Criteria: * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy; or long-term systemic corticosteroid therapy * History of meningococcal infection * History of any neurological disorders * History of Guillain-Barré syndrome * History of an Arthus-type hypersensitivity reaction after a previous dose of tetanus toxoid-containing vaccine * At high risk for meningococcal infection during the study * Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances * Self-reported thrombocytopenia, contraindicating intramuscular injection * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection * 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 judgment) or febrile illness (axillary temperature ≥37.5°C \[99.5℉\]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. * Receipt of any live vaccines within 14 days preceding the trial vaccination or planned receipt of any live vaccines in 14 days following trial vaccination, and receipt of any inactivated vaccines in 8 days preceding the trial vaccination or planned receipt of any live vaccines in 8 days following trial vaccination * For Cohort I (12 to 23 MoA): receipt of any other meningococcal vaccine except the meningococcal group A polysaccharide vaccine included in the NIP. The time since last vaccination of meningococcal group A or groups A and C polysaccharide vaccine of 6 months or less should be excluded. * For Cohorts II (6 to 11 MoA) and III (2 to 5 MoA): a vaccination history of any meningococcal vaccine. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw. * Participation at the time of study enrollment (or in the 4 weeks preceding the study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. * In an emergency setting, or being hospitalized * Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study The above information is 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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Investigational Site Number : 1561001
RECRUITINGJingxi, 533899, China
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Investigational Site Number : 1561002
RECRUITINGTengzhou Town, 543399, China
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Investigational Site Number : 1561003
RECRUITINGLiuzhou, 545100, China
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