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Massive malawi trial aims to shield kids from typhoid

NCT ID NCT03299426

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 2 times

Summary

This large phase 3 trial is testing a typhoid conjugate vaccine (Vi-TCV) in 30,000 healthy children aged 9 months to 12 years in Malawi. Half get the typhoid vaccine, half get a meningitis vaccine for comparison. The goal is to see if the typhoid vaccine prevents blood-confirmed typhoid fever and is safe.

What this could mean

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

Active substance
Typhoid conjugate vaccine (Vi-TCV)
What this could lead to
If it works, this vaccine could protect children in typhoid-prone areas from a serious bacterial infection, reducing illness and deaths.
What could go wrong
This is a large trial, but results may not apply to all regions. The vaccine may cause side effects like pain or fever, and its long-term protection is still being studied.

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 30,000 people

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

Started

Feb 2018

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

9 months to 12 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: * Healthy male or female child between the ages of 9 months and 12 years/364 days at the time of study vaccination. * A child whose parent or guardian resides primarily within the Ndirande or Zingwangwa study areas at the time of study vaccinations and who intends to be present in the area for the duration of the trial. * A child whose parent or guardian has voluntarily given informed consent. Exclusion Criteria: * History of documented hypersensitivity to any component of the vaccine * Prior receipt of any typhoid vaccine in the past 3 years * History of severe allergic reaction with generalized urticarial, angioedema, or anaphylaxis * Any condition determined by the investigator to be likely to interfere with evaluation of the vaccine or to be a significant potential health risk to the child or make it unlikely that the child would complete the study. Temporary Exclusion Criteria: The following will be considered temporary contraindications to enrollment and vaccination. If these apply, the participant will be temporarily excluded for vaccination until 48 hours has passed. A re-assessment will be needed to ensure these temporary exclusion criteria no longer exist. * Reported fever within 24 hours prior to vaccination * Use of anti-pyretics within 4 hours prior to vaccination An additional temporary exclusion criteria will be: \- Receipt of measles vaccine in the one month prior to enrollment, as determined by parental history or vaccination card. Additional Exclusion Criteria for Safety and Immunogenicity Substudy: In addition to the exclusion criteria of the efficacy study, participants enrolled in the immunogenicity and reactogenicity substudy may not have, or have had, any: * Known history of diabetes, tuberculosis, cancer, chronic kidney, heart, or liver disease, progressive neurological disorders, poorly controlled seizures, or terminal illness * Severe malnutrition as determined by MUAC\< 12.5 cm for children younger than 5 years; * Receipt of any other investigational intervention in the last 6 months or anticipated during the course of the study. * Receipt of blood products in the last 6 months. * Known HIV-infection or exposure or other immunosuppressive conditions. * Receipt of systemic immunosuppressant or systemic corticosteroids. * Receipt of any measles-containing vaccine for children younger than 1 year of age

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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

  • Malawi Liverpool Wellcome Trust Clinical Research Programme, Queen Elizabeth Central Hospital College of Medicine

    Blantyre, P.O. Box 30096, Malawi

More trials for these conditions

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