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

Invasive Group B Streptococcal Disease Clinical Trial

Official title:

Burden of Invasive Group B Streptococcal (GBS) Disease in Young Infants in China: Incidence, Case Fatality Rate and Serotype Distribution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933646
• Other study ID #: V98_23OB
• Status: Completed
• Phase: N/A
• First received: August 28, 2013
• Last updated: January 6, 2015
• Start date: September 2013
• Est. completion date: September 2014

Study information

• Verified date: January 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 90 Days

Eligibility

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:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Invasive Group B Streptococcal Disease

Locations

Country	Name	City	State
China	Site 12	Changsha
China	Site 13	Guangzhou
China	Site 14	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

China, 

References & Publications (1)

Heath PT, Schuchat A. Perinatal group B streptococcal disease. Best Pract Res Clin Obstet Gynaecol. 2007 Jun;21(3):411-24. Epub 2007 Mar 2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of group B streptococcal (GBS) disease		From birth to 90 days of age	No
Primary	Case Fatality Rate of GBS disease		From birth to 90 days of age	No
Primary	GBS serotype distribution		From birth to 90 days of age	No