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Preparing for Maternal GBS Vaccine Trials in Africa

Recruitingn/aAges any - anyAllBarcelona Institute for Global Health
NCT06833957 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Infections are one of the key causes of newborn deaths. Among them, Group B Streptococcus (GBS) is the leading cause of sepsis and bacterial meningitis in the first 90 days of life. Fortunately, GBS vaccines for pregnant women, a powerful tool for fighting infections, are currently in development. Once vaccine trials are completed, these vaccines can stop preventable newborn deaths. The PReparing for Optimal Phase III/IV maTErnal Group B StreptococCal vaccine Trials in Africa (PROTECT) project, funded by the European \& Developing Countries Clinical Trials Partnership (EDCTP) and European Commission, is supporting medical sites in Kenya, Malawi, Mozambique, and Uganda to establish uniform pregnancy and infant health data collection processes. It is also establishing surveillance of GBS in newborns to determine incidence rates and measure the burden of disease. With better reporting sys

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📋 Eligibility rules (as published)
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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What it tests

  • Not listed
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Where

10 sites
Mariakani Sub-County Hospital
Mariakani, Kenya
Malindi Sub County Hospital in Malindi
Malindi, Kenya
Rabai Sub County Hospital
Rabai, Kenya
Queen Elizabeth Central Hospital
Blantyre, Malawi
Lirangwe Health Centre
Blantyre, Malawi
Ndirande Health Centre
Blantyre, Malawi
Hospital Geral De Mavalane
Maputo, Mozambique
Manhiça District Hospital
Manhiça, Mozambique

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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