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

Completed

• Conditions: Invasive Group B Streptococcal Disease

• Registration Number: NCT01933646
• Lead Sponsor: Novartis Vaccines

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2013-08-28
• Study First Submitted QC: 2013-08-28
• Study Start: 2013-09
• Study First Posted: 2013-09-02
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-06
• Last Update Posted: 2015-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Case Fatality Rate of GBS disease	From birth to 90 days of age
Incidence of group B streptococcal (GBS) disease	From birth to 90 days of age
GBS serotype distribution	From birth to 90 days of age

Trial Locations

Locations (3)

Site 13; 🇨🇳 Guangzhou, China

Site 14; 🇨🇳 Guangzhou, China

Site 12; 🇨🇳 Changsha, China