New vaccine study aims to shield toddlers from deadly meningitis
NCT ID NCT05935176
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a vaccine designed to protect young children from four types of meningitis bacteria. Researchers gave the vaccine to 660 toddlers aged 6 to 23 months and will check their immune response over time. Some children will also receive a booster shot at age 3 to see if protection lasts longer. The goal is to confirm the vaccine works well and is safe for this age group.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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660 people
The number who actually took part.
- Started
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Sep 2023
- Expected to finish
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Jul 2026
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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6 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.
Part Ⅰ Inclusion Criteria: * Children aged 6 to 23 months at the time of screening * Volunteers who have not received any vaccine containing a epidemic encephalitis component or who have received only the group A polysaccharide flu vaccine and have been vaccinated more than 6 months since their last vaccination. 6 months or more between the last vaccination and the last vaccination * The legal guardian or delegate has given informed consent, voluntarily signed the informed consent form, and is able to comply with the requirements of the clinical study protocol Exclusion Criteria: * Fever before inoculation, axillary temperature \>37.0℃ * History of epilepsy, convulsions or seizures or history of psychiatric disorders or family history * During an acute illness episode; with a serious chronic illness or a condition that is in a progressive stage that cannot be smoothly controlled (or an acute episode) * Known allergy to a component of the vaccine, especially to diphtheria toxoid * Live attenuated vaccine received within 14 days or other vaccine received within 7 days prior to enrollment * Other circumstances that, in the judgment of the investigator, make participation in this clinical study inappropriate * Those who had a severe allergic reaction after the previous dose of vaccine * Those with serious adverse reactions causally related to the previous dose of vaccination * Newly identified or newly occurred cases after the first vaccination that do not meet the inclusion criteria for the first dose or meet the exclusion criteria for the first dose will be determined by the investigator whether to continue to participate in the study Part Ⅱ Inclusion Criteria: * The first phase of the study has been completed, involving the (0, 3) month vaccination schedule group for subjects aged 6 to 11 months. All subjects received two doses as required, and blood samples were collected 30 days after the primary vaccination series. * Children aged 3 years at the time of screening * The trial participant is able and willing to comply with the requirements of the clinical trial protocol and can complete the 1-month study follow-up. * The trial participants did not receive any meningococcal vaccine booster doses at age 3 years * The legal guardian or authorized representative voluntarily signs the informed consent form with full knowledge and understanding, and is able to comply with the requirements of the clinical research protocol. Exclusion Criteria: * Fever prior to vaccination, with axillary temperature \>37.0°C * History of epilepsy, convulsions, or seizures; psychiatric history or family history of psychiatric disorders * During acute phase of illness; severe chronic disease or progressive condition not well controlled (or in acute phase) * Known allergy to any vaccine component, particularly diphtheria toxoid * Receipt of live attenuated vaccines within 14 days or other vaccines within 7 days prior to enrollment * Other conditions deemed ineligible for this clinical study by the investigator
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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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Wuzhi County Center for Disease Control and Prevention
Jiaozuo, Henan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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