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Development of a Serocorrelate of Protection Against Invasive Group B Streptococcus Disease

NCT04735419 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2023-11-22

No results posted yet for this study

Summary

A multicentre study to provide evidence that the relationship between an immune marker value (anti-GBS IgG concentration) and the probability of invasive GBS (iGBS) disease in infants less than 90 days of age is sufficiently strong that a vaccine able to induce an immune response will lead to a meaningful decrease in the probability of iGBS disease.

Conditions

  • Streptococcus Agalactiae Infection

Interventions

OTHER

No intervention

No intervention

Sponsors & Collaborators

  • Medical Research Council

    collaborator OTHER_GOV

  • University of Nottingham

    collaborator OTHER

  • Public Health England

    collaborator OTHER_GOV

  • St George's, University of London

    lead OTHER

Principal Investigators

  • Paul Heath · St George's, University of London

Eligibility

Min Age
0 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2024-03-30
Completion
2024-03-30

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04735419 on ClinicalTrials.gov