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

NCT ID: NCT02099149

Last Updated: 2014-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Invasive Group B Streptococcus Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Controls

Infants born to GBS colonized mother who do not develop GBS disease

No interventions assigned to this group

Cases

Infants with culture confirmed GBS disease

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

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Respiratory and Meningeal Pathogen Research Unit

Soweto, Gauteng, South Africa

Site Status

Countries

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South Africa

Other Identifiers

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V98_28OB

Identifier Type: -

Identifier Source: org_study_id

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