Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2025-12-24 @ 6:30 PM
NCT ID:
NCT06833957
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT06833957
Study Brief:
Protocol Section:
NCT06833957