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

January 6, 2015 updated by: Novartis Vaccines

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Changsha, China
        • Site 12
      • Guangzhou, China
        • Site 13
      • Guangzhou, China
        • Site 14

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infants (up to and including 90 days of age) born in or treated in a study hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of group B streptococcal (GBS) disease
Time Frame: From birth to 90 days of age
From birth to 90 days of age
Case Fatality Rate of GBS disease
Time Frame: From birth to 90 days of age
From birth to 90 days of age
GBS serotype distribution
Time Frame: From birth to 90 days of age
From birth to 90 days of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Vaccines

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

August 28, 2013

First Submitted That Met QC Criteria

August 28, 2013

First Posted (ESTIMATE)

September 2, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 7, 2015

Last Update Submitted That Met QC Criteria

January 6, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • V98_23OB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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