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Can a new vaccine safely shield babies from meningitis?

NCT ID NCT06389513

Prevention Sponsor: CanSino Biologics Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This trial is testing the safety of the Menhycia® vaccine in about 3,000 healthy 3-month-old infants who have not yet received any epidemic meningitis vaccine. The infants will receive three doses of the vaccine at least one month apart, with an optional booster at 12 months of age. Researchers will monitor for any local or systemic side effects, such as fever or injection-site reactions, to ensure the vaccine is safe for this age group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Menhycia® (MCV4) vaccine
What this could lead to
If successful, this could confirm that Menhycia® is safe for routine use in young infants, helping protect them against epidemic meningitis.
What could go wrong
This is a safety-focused study, not designed to measure effectiveness. Possible side effects include local reactions like redness or swelling, and systemic reactions like fever.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

3,011 people

The number who actually took part.

Started

Jun 2024

Finished

May 2026

Lead sponsor

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

3 to 3 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: * Infants 3 months of age who had not received any epidemic encephalitis vaccine at the time of screening * The legal guardian or delegate has given informed consent, has voluntarily signed an informed consent form, and is able to comply with the requirements of the clinical study protocol Exclusion Criteria: First dose exclusion criteria * Fever before vaccination, axillary temperature \>37.0°C * Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc. * History of epilepsy, convulsions or seizures or history or family history of psychiatric disorders * Acute infections or active chronic diseases, severe infectious or allergic skin diseases * Known allergy to a component of the vaccine, especially to diphtheria toxoid, or to previous administration of the product * Other circumstances that, in the judgment of the investigator, make participation in this clinical study inappropriate Subsequent dose exclusion criteria * Severe allergic reactions after a previous dose of vaccine * Those with serious adverse reactions causally related to the previous dose of vaccination * Other circumstances that, in the judgment of the investigator, make participation in this clinical study inappropriate

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Conditions

The condition(s) this trial relates to.

meningococcal meningitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Epidemic meningitis

Contacts and locations

Locations

  • Nanjing Luhe District Center for Disease Control and Prevention Center for Disease Control and Prevention

    Nanjing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.