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New vaccine aims to stop deadly diarrhea in thousands of children

NCT ID NCT06838195

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a two-dose vaccine designed to prevent diarrhea from two common types of Shigella bacteria in 8,000 children aged 6 months to 5 years in Bangladesh. Half the children get the vaccine, half get a placebo, and researchers track who gets sick over time. The goal is to see if the vaccine safely reduces cases of Shigella-related diarrhea.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 8,000 people

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

Started

May 2025

Expected to finish

Jul 2028

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

6 months to 5 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: * Infants and children aged 6 months to 5 years. * Legal guardians voluntarily agree to participate in the study and sign an informed consent form. * Legal guardians agree to comply with the requirements of the clinical trial protocol and are willing and able to participate in all planned follow-ups. * The subject's guardian agrees that the subject should not abuse antibiotics. If needed,antibiotics should be used under the guidance of a doctor and avoid taking antibiotics on their own during the clinical trial. * Based on medical history, physical examination, and the investigator's judgment, the subject is determined to be in good health. Exclusion Criteria: * History of confirmed bacterial dysentery in the past 6 months. * Serious allergy to tetanus toxoid, history of severe allergies, fever above 39.5°C following previous vaccination with a prophylactic biological product. * Currently suffering from serious intestinal diseases, symptoms of diarrhea, abdominal pain, or bloody purulent stools in the past 15 days. * Diagnosed pathological jaundice currently. * Confirmed diagnosis of thrombocytopenia or other coagulation disorders. * Known or suspected immunological deficiencies (e.g., perianal abscesses indicating potential immune deficiency in infants and young children), long-term treatment (≥14 days) with immunosuppressants within half a year before vaccination (radiotherapy, chemotherapy, systemic corticosteroids ≥2 mg/kg/day, antimetabolites, cytotoxic drugs), or parents confirmed to have HIV infection. * Receipt of immunoglobulins/blood products (except hepatitis B immunoglobulin) within 3 months before vaccination. * Severe congenital anomalies (important organ function impairment), severe malnutrition, developmental disorders, severe hereditary diseases. * Currently suffering from the following diseases: 1. Severe liver or kidney diseases, cardiovascular diseases, malignant tumors, and other severe chronic diseases. 2. Diagnosed serious infectious diseases, such as tuberculosis, viral hepatitis, etc. 3. Severe asthma. 4. Generalized rashes, dermatophytosis, skin suppuration, or blistering. 5. Convulsions, epilepsy, encephalopathy, psychiatric disorders or family history of psychiatric disorders. * Planning to participate or currently participating in other vaccine or drug clinical trials. * Any condition that the investigators believe may affect the evaluation of the study.

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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

  • Icddr,B

    Dhaka, 1216, Bangladesh