Malawi shifts vaccine strategy to boost herd immunity against pneumonia
NCT ID NCT04078997
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study in Blantyre, Malawi, compares two schedules of the pneumococcal conjugate vaccine (PCV13): the current 3-dose schedule without a booster (3+0) versus a 2-dose schedule with a booster at 9 months (2+1). The goal is to see if the booster reduces carriage of vaccine-type pneumococcal bacteria in children and adults, thereby improving herd immunity. Over 3,500 participants, including children and HIV-infected adults, will have nasopharyngeal swabs taken to measure bacterial carriage. Results will help Malawi's health officials decide whether to change the national vaccine schedule.
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 13 (PCV13)
- What this could lead to
- If successful, this could show that a 2+1 vaccine schedule provides better protection against pneumococcal disease in low-income countries, informing national vaccine policies.
- What could go wrong
- This is an observational effectiveness study, not a randomized controlled trial, so results may be influenced by other factors. The study is also limited to one district in Malawi, so findings may not apply elsewhere.
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.
- Participants
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3,507 people
The number who actually took part.
- Started
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Jul 2019
- Finished
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Feb 2024
- 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.
Who is studied
PCV13-vaccinated,15-24 months of age: Recruitment at randomly selected households within each of the catchment areas (zones) of the 20 selected health centers. PCV13-vaccinated, 9 months of age: Recruitment will take place at MoH EPI vaccination centers. PCV13-vaccinated, 5-10 years of age: Recruitment from six selected six schools: three located centrally in each of the 3+0 zones, and three in the 2+1 zones. PCV13-unvaccinated HIV-infected adults on ART 18 - 40 years old: Recruitment from the Queen Elizabeth Central Hospital (QECH), Lighthouse ART clinic in Blantyre.
- Ages
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15 months to 40 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 PCV13-vaccinated children, 15-24 months of age (schedule 2+1 or 3+1): * Aged between 15-24 month * Permanent resident in Blantyre District * Parent/legal guardian consent for the child to have a NP swab taken * Evidence of having received a full schedule of PCV13 vaccination recorded in the health passport and which schedule given PCV13-vaccinated children, 9 months of age (schedule 2+0 or 3+0): * Aged 9 months * Permanent resident in Blantyre District * Parent/legal guardian consent for the child to have a NP swab taken * Evidence of having received either a full 3+0 schedule or both primary doses (at approximately 6 and 14 weeks of age) of the 2+1 schedule of PCV13 vaccination recorded in the health passport PCV13-vaccinated children, 5-10 years of age (schedule 3+0): * Aged between 5-10 years * Parent/legal guardian consent for the child to have a NP swab taken * If the child is ≥8 years old, child assent to have a NP swab taken * Either verbal or documented evidence of having received primary immunization with PCV PCV13-unvaccinated HIV-infected adults on ART 18 - 40 years of age: • Aged 18-40 years EXCLUSION CRITERIA: For all participants: * Current TB treatment * Pneumonia hospitalization \<14 days before study enrolment * Terminal illness For Children: * No parental/legal guardian consent * No child assent (children aged \>8 years old) * Having received antibiotic treatment \<14 days before study enrolment For Adults: * Unable or unwilling to provide consent * Prior vaccination with pneumococcal vaccine
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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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Malawi-Liverpool-Wellcome Research Programme
Blantyre, Chichiri, P.O. Box 30096, Malawi
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