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Antibody Levels Associated With Reduced Risk of Invasive Group B Streptococcus Disease in Infants Aged Less Than 90 Days

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Novartis

Status

Withdrawn

Conditions

Invasive Group B Streptococcus Disease

Study type

Observational

Funder types

Industry

Identifiers

NCT02099149
V98_28OB

Details and patient eligibility

About

Compare anticapsular antibody levels against Group B Streptococcus at delivery in mothers and their infants who develop disease versus those who do not. Use this comparison to establish antibody levels associated with reductions in risk of GBS disease in infants aged less than 90 days.

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Pregnant women attending participating community/hospital antenatal clinics and/or delivering at participating delivery centers.
  • Subjects aged ≥18 years.
  • Able to understand and comply with planned study procedures.
  • Provides written informed consent.

Exclusion criteria

  • Refuses to consent to study participation.

Trial design

0 participants in 2 patient groups

Controls
Description:
Infants born to GBS colonized mother who do not develop GBS disease
Cases
Description:
Infants with culture confirmed GBS disease

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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