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Can a pneumonia vaccine protect the most vulnerable children?

NCT ID NCT06817421

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a pneumococcal vaccine (Pneumosil) can produce a strong immune response in children aged 6-59 months who are hospitalised with severe acute malnutrition. Half the children will receive the pneumococcal vaccine, and the other half will receive a typhoid vaccine as a control. Researchers will measure antibody levels over six months to see if the vaccine works well in these malnourished children.

What this could mean

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

Active substance
Pneumococcal conjugate vaccine (Pneumosil)
What this could lead to
If successful, this could show that giving pneumococcal vaccine to severely malnourished children helps protect them against pneumonia and other infections.
What could go wrong
This is a single-centre trial with only 214 children, so results may not apply everywhere. The immune response in malnourished children may be weaker than expected.

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 214 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Feb 2029

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

6 to 59 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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. Aged 6-59 months at the time of hospitalisation 2. Hospitalised with severe acute malnutrition (SAM, defined as any one of a, b, or c): 1. weight-for-length/height z-score \<-3; or 2. middle upper arm circumference \<11.5cm; or 3. bilateral pitting pedal oedema unexplained by other causes 3. Parent/carer is willing for their child to participate in the study and has provided written informed consent 4. Parent/carer is willing to comply with all study procedures outlined in the protocol, including specimen collection, for the duration of the study Exclusion Criteria: 1. Known history of allergy or hypersensitivity to any component of either study vaccine, including diphtheria toxoid, or a history of anaphylactic shock. 2. Treatment with another investigational drug or other intervention in the 30 days prior to randomisation, or ongoing participation in another clinical trial. 3. Suspected primary or secondary immunodeficiency or prolonged administration (\>14 days) of an immune modifying drug (including oral glucocorticoids) in the past 3 months. 4. Known terminal illness expected to result in death within 6 months. 5. Participants who, in the opinion of the site Principal Investigator, are unable to comply with the study protocol, including scheduled visits, assessments, and any other protocol-required procedures. 6. Previously enrolled in this trial.

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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

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Guido Valadares National Hospital (HNGV)

    Dili, Timor-Leste, Timor-Leste

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