New vaccine aims to stop deadly diarrhea in thousands of children
NCT ID NCT06838195
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.
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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 8,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Jul 2028
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 months to 5 years
- 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: * 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
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Icddr,B
Dhaka, 1216, Bangladesh