Burden of Invasive Group B Streptococcal (GBS) Disease in Young Infants in China

NCT ID: NCT01933646

Last Updated: 2015-01-07

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

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-09-30

Brief Summary

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Evaluate the burden of invasive group B streptococcal (GBS) disease in young infants (up to 90 days of age) in China, in terms of incidence, case fatality rate and serotype distribution

Detailed Description

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Conditions

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Invasive Group B Streptococcal Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Positive culture for GBS from one or more of the following normally sterile sites: blood, cerebrospinal fluid (CSF), pleural fluid, peritoneal fluid, pericardial fluid, surgical aspirate, bone, joint fluid, suprapubic bladder aspiration or internal body site (e.g., lymph node, brain).
2. ≤90 days old at the time of GBS confirmation.
3. Voluntary written informed consent provided.

Exclusion Criteria

* None.
Maximum Eligible Age

90 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Vaccines

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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Site 12

Changsha, , China

Site Status

Site 13

Guangzhou, , China

Site Status

Site 14

Guangzhou, , China

Site Status

Countries

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China

References

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Heath PT, Schuchat A. Perinatal group B streptococcal disease. Best Pract Res Clin Obstet Gynaecol. 2007 Jun;21(3):411-24. doi: 10.1016/j.bpobgyn.2007.01.003. Epub 2007 Mar 2.

Reference Type BACKGROUND
PMID: 17336588 (View on PubMed)

Other Identifiers

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V98_23OB

Identifier Type: -

Identifier Source: org_study_id

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