Can a pneumonia vaccine protect the most vulnerable children?
NCT ID NCT06817421
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 214 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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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
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6 to 59 months
- Sex
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Anyone
- Healthy volunteers
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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 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: 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Guido Valadares National Hospital (HNGV)
Dili, Timor-Leste, Timor-Leste
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new vaccine outsmart pneumococcal disease?
- Can a new formula save more children from severe malnutrition?
- AI takes the wheel: could a computer outthink doctors on ventilator settings for kids?
- A Mother's tape measure could save children from malnutrition relapse
- New vaccine aims to shield kids from pneumonia and meningitis
- New vaccine aims to shield babies from pneumonia and meningitis