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New combo vaccine targets deadly diarrhea in kids

NCT ID NCT05987488

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested a new vaccine called ShigETEC in healthy adults and children in Bangladesh. The vaccine aims to protect against two bacteria that cause severe diarrhea: Shigella and ETEC. Researchers gave three doses of the vaccine or a placebo to 196 participants to check if it is safe and triggers an immune response. The trial is a first step in developing a vaccine for these common infections.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

196 people

The number who actually took part.

Started

Nov 2023

Finished

Dec 2025

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 45 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: * Male or female adults, children, toddlers, and infants aged between 18-45 years, 2-5 years, 12-23 months, and 6-11 months, respectively at the time of vaccination. * Free of obvious health problems as determined by medical history and clinical examination before entering into the study. * Normal bowel habits. * Informed consent form signed. * Negative pregnancy tests before each vaccination for females of childbearing potential. Adult participants agree to use birth control steps or abstinence. Exclusion Criteria: * Nursing and breast-feeding women. * Presence of any known significant medical or psychiatric condition / systemic disorder. * History of congenital abdominal disorders, intussusception, abdominal surgery, any other congenital disorder, any neurologic disorders or seizures. * Clinically significant abnormalities in screening hematology, serum chemistry. * Known or suspected HIV, hepatitis infection. * Clinical evidence of active gastrointestinal illness or acute disease at the time of enrolment. * Prior receipt of any Shigella or ETEC vaccine, blood transfusion or blood products. * History of febrile illness within 48 hours prior to vaccination or fever at the time of immunization. * History of diarrhoea within 7 days and / or acute diarrhoea due to culture confirmed Shigella or ETEC infections within one month prior to vaccination. * Screening stool positive for any Shigella or ETEC strain by culture. * Participation in research involving another investigational product within 30 days before before planned date of first vaccination concurrent participation in another clinical trial. * Receipt of antimicrobial drugs for any reason within 7 days before vaccination. * Allergy to quinolone, sulfa, and penicillin classes of antibiotics * Any conditions which, in the opinion of the investigator, might jeopardize the safety of study participants or interfere with the evaluation of the study objectives.

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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

  • International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b)

    Dhaka, Bangladesh

More trials for these conditions

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