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Could a cholera vaccine stop Kids' diarrhea?

NCT ID NCT07300462

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This large study tests whether an oral cholera vaccine can also protect children aged 2 to 14 from infectious diarrhea caused by other germs. 6,000 healthy kids will get either the vaccine or a placebo. The goal is to see if the vaccine lowers the number of diarrhea cases, building on earlier hints of broader protection.

What this could mean

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

Active substance
oral recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules)
What this could lead to
If successful, this vaccine could help prevent common infectious diarrhea in children, reducing illness and antibiotic use.
What could go wrong
This is a large phase 4 trial, but the vaccine is being tested for a new use (non-cholera diarrhea). It may not work as well in real-world conditions, and side effects 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

Phase 4

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

Participants

About 6,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jan 2027

An estimate. End dates often move.

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

2 to 14 years

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: 1. Age ≥ 2 years old, ≤ 14 years old, male or female. 2. Not vaccinated against cholera. 3. Obtain the consent of the study subject or guardian and sign the informed consent form. 4. The subjects and their guardians were able to comply with the requirements of the clinical study protocol. 5. Axillary temperature \< 37.0 °C was measured on the day of inoculation. Exclusion Criteria: * Exclusion Criteria for First Inoculation: 1. Patients with febrile illness (axillary temperature ≥ 37.0 °C on the day of vaccination), other acute diseases, and diarrhea within 7 days before vaccination. 2. Use of antibiotics within 7 days prior to vaccination. 3. Patients with gastric ulcer, abnormal gastric acid secretion and other gastric diseases or discomfort. 4. History of allergy to vaccinations and oral medications. 5. Patients with congenital malformations, developmental disorders, or severe chronic diseases. 6. Suspected progressive neurological disorder, epilepsy, or long-term use of antibiotics. 7. Received blood products within 3 months prior to vaccination. 8. Received other investigational drugs within 30 days prior to vaccination. 9. Received any Rotavirus vaccine within 12 months prior to vaccination. 10. Live attenuated vaccine within 14 days or subunit or inactivated vaccine within 7 days prior to vaccination. 11. Asthma requiring urgent treatment, hospitalization, intubation, oral or intravenous corticosteroids for unstable past two years. 12. Patients with severe hypertension, heart, liver, kidney disease, and severe infectious diseases (acquired immunodeficiency syndrome and active tuberculosis). 13. Has a malignancy, is active or has been treated without definitive cure, or has the potential to relapse during the study. 14. Epilepsy, excluding epilepsy that has been discontinued within the past 3 years and has not recurred. 15. Patients with coagulation disorders. 16. Those who have had or are currently suffering from mental illness that have not been well controlled within the past two years due to psychological conditions that do not comply with protocol requirements, and who need to take drugs for psychosis. 17. In the judgment of the investigator, it is contrary to the protocol due to various medical, psychological, social or other conditions, or affects the subject to sign the informed consent. * Exclusion Criteria for Second and Third Oral Vaccines: 1. Those who have an allergic reaction at the time of the first or second vaccination. 2. Occurring in any of the first dose exclusion criteria after inclusion. 3. Serious adverse event causally related to first or second dose of study vaccine.

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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.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. 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

Locations

  • Anhui Provincial Center for Disease Control and Prevention

    Hefei, Anhui, China

  • Hubei Provincial Center for Disease Control and Prevention

    Wuhan, Hubei, China

  • Jiangsu Provincial Center for Disease Control and Prevention

    Nanjing, Jiangsu, China

  • National Institute for Communicable Disease Control and Prevention, China

    Beijing, Beijing Municipality, China

  • Shandong Provincial Center for Disease Control and Prevention

    Jinan, Shandong, China

More trials for these conditions

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