NCT01933646

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2013

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

January 7, 2015

Status Verified

January 1, 2015

Enrollment Period

1 year

First QC Date

August 28, 2013

Last Update Submit

January 6, 2015

Conditions

Invasive Group B Streptococcal Disease

Keywords

Group B streptococcusIncidenceCase fatality rateSerotype distribution

Outcome Measures

Primary Outcomes (3)

  • Incidence of group B streptococcal (GBS) disease

    From birth to 90 days of age

  • Case Fatality Rate of GBS disease

    From birth to 90 days of age

  • GBS serotype distribution

    From birth to 90 days of age

Study Arms (1)

Cohort 1

Eligibility Criteria

AgeUp to 90 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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).
  • ≤90 days old at the time of GBS confirmation.
  • Voluntary written informed consent provided.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Site 12

Changsha, China

Location

Site 13

Guangzhou, China

Location

Site 14

Guangzhou, China

Location

Related Publications (1)

  • 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.

    PMID: 17336588BACKGROUND

Study Officials

  • Novartis Vaccines

    Novartis Vaccines

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2013

First Posted

September 2, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

January 7, 2015

Record last verified: 2015-01

Locations

CN(3)