UnknownNot Applicable

Serocorrelate of Protection Against GBS (PREPARE WP3)

France, Italy, Malawi600 participantsStarted 2020-04-01

Plain-language summary

A multicentre, international case-control study to develop a biobank of sera from 150 cases of serotype III GBS disease and associated clinical information from seven countries (Malawi, Uganda, UK, the Netherlands, Italy and France), with 3:1 (450) serotype matched healthy controls.

Who can participate

Age range90 Days

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: Cases: Infant 0-90 days of life with GBS identified from a normally sterile site. Controls: Healthy infant born to a GBS colonised woman that does not develop GBS disease between birth and 90 days of life. Exclusion Criteria An infant is not eligible unless a parent/person with parental responsibility gives informed consent.

What they're measuring

To establish a biobank of at least 150 GBS serotype III cases including both the isolate and associated maternal and infant serum.

Timeframe: Over the course of 2 years

Trial details

NCT IDNCT04732026

SponsorSt George's, University of London

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-03-01

Contact for this trial

Hannah Davies, Dr

+442087255214 hdavies@sgul.ac.uk

View on ClinicalTrials.gov More Group B Streptococcus Carrier in Childbirth trials