Groundwork laid for lifesaving GBS vaccine trials in africa
NCT ID NCT06833957
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study prepares medical sites in Kenya, Malawi, Mozambique, and Uganda for future trials of a vaccine against Group B Streptococcus (GBS), a leading cause of serious infections in newborns. Researchers will track pregnancy and infant health data and monitor GBS cases in babies under 90 days old. The goal is to build a network that can test and monitor the safety of GBS vaccines, ultimately preventing newborn deaths.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 18,100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Feb 2027
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.
Who is studied
WP2 Pregnancy Exposure Registries study population: Pregnant women and their infants up to hospital discharge at the chosen health facilities in Uganda, Malawi, Mozambique, and Kenya. WP3 GBS surveillance study population: All infants less than 90 days old admitted with GBS infection detected in blood or CSF by culture, or GBS detected in CSF by qPCR, at referral health facilities in the four countries during a period of at least 12 months. WP4 study population: All pregnant women attending the identified health facilities at the time of fieldwork and the health care workers who provide services to these women. It will also consist of stakeholders including, but not limited to, health workers from each country's Ministry of Health, head of facilities, community leaders (community gatekeepers and influencers), older women who give support in the community, male leaders, religious, political, administrative or cultural leaders.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- 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: * WP2 Pregnancy Exposure Registries inclusion criteria: All women and their infants attending for antenatal and/or delivery and postpartum services at the study sites in Uganda, Malawi, Mozambique, and Kenya. WP3 GBS Surveillance inclusion criteria: * Infants aged less than 90 days old with laboratory-confirmed GBS infection admitted at participating health facilities in Uganda, Malawi, Mozambique, and Kenya. * Infants whose parents or guardians provided written informed consent for their participation. * Residents in the catchment area of participating health facilities. WP4 Vaccine Confidence inclusion criteria: * In Uganda, Kenya and Mozambique, pregnant women at any gestation period aged 18 years and above (reproductive age). * In Malawi, pregnant women aged 16 years are eligible to be included in the study because they are considered emancipated minors. * Pregnant women who consent to the study and give written consent. * Stakeholders who include pregnant women, health workers, women leaders, community leaders, national stakeholders, cultural and religious leaders who are willing to take part and can give written informed consent. Exclusion Criteria: WP4 Vaccine Confidence exclusion criteria: * Pregnant women who are visiting/non-resident in the research area. * Those who may be unwell and unable to consent to take part in the study.
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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
10 sites in 4 countries. 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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Hospital Geral De Mavalane
RECRUITINGMaputo, Cidade de Maputo, 1100, Mozambique
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Kawempe National Referral Hospital
RECRUITINGKampala, Kampala, P. O Box 3253, Uganda
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Komamboga Health Centre III
RECRUITINGKampala, Komamboga, 4126, Uganda
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Lirangwe Health Centre
RECRUITINGBlantyre, Blantyre District, Malawi
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Malindi Sub County Hospital in Malindi
RECRUITINGMalindi, Kilifi County, 80200, Kenya
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Manhiça District Hospital
RECRUITINGManhiça, Manhiça, Mozambique
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Mariakani Sub-County Hospital
RECRUITINGMariakani, Coast, 80113, Kenya
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Ndirande Health Centre
RECRUITINGBlantyre, Blantyre, Malawi
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Queen Elizabeth Central Hospital
RECRUITINGBlantyre, Blantyre District, Box 95, Malawi
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Rabai Sub County Hospital
RECRUITINGRabai, Kilifi County, 80114, Kenya
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