CompletedNot Applicable

Group B Strep Correlates of Protection Study

South Africa17,842 participantsStarted 2019-03-01

Plain-language summary

Streptococcus agalactiae or Group B Streptococcus (GBS) is a leading cause of neonatal sepsis in developed and developing countries. The study aims to bolster the evidence base of establishing a sero-correlate of protection against invasive GBS disease in infants. These sero-correlates of protection will be used to study the effectiveness of GBS vaccine against invasive disease.

Who can participate

Age range18 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Pregnant women attending for antenatal care at one of the participating antenatal-clinics and/or delivering at CHBAH or RMMCH.
✓. Subjects aged ≥18 years.
✓. Able to understand and comply with planned study procedures.
✓. Provides written informed consent.

Exclusion criteria

✕. Refusal to consent to study participation.
✕. Receipt of any blood products in the past 4 weeks or anticipated during labour.

What they're measuring

Primary Objective

Timeframe: 1 - 1.5 years

Trial details

NCT IDNCT06431217

SponsorUniversity of Witwatersrand, South Africa

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-12-31

View on ClinicalTrials.gov More Maternal Health trials