NCT02099149

Brief Summary

Compare anticapsular antibody levels against Group B Streptococcus at delivery in mothers and their infants who develop disease versus those who do not. Use this comparison to establish antibody levels associated with reductions in risk of GBS disease in infants aged less than 90 days.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

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

March 25, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

July 24, 2014

Status Verified

July 1, 2014

Enrollment Period

1.3 years

First QC Date

March 25, 2014

Last Update Submit

July 23, 2014

Conditions

Invasive Group B Streptococcus Disease

Keywords

Group B Streptococcusearly onset diseaselate onset diseaseanticapsular antibodiesserotype specific

Outcome Measures

Primary Outcomes (1)

  • Early onset Group B Streptococcus Disease due to serotypes Ia or III

    Risk of early onset Group B Streptococcus disease (due to serotypes Ia or III) with respect to maternal or newborn anticapsular antibody levels at delivery

    0-6 days

Secondary Outcomes (1)

  • Late onset Group B Streptococcus Disease due to serotype III

    7-90 days

Study Arms (2)

Controls

Infants born to GBS colonized mother who do not develop GBS disease

Cases

Infants with culture confirmed GBS disease

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women aged 18 years or older attending for antenatal care or delivery at 3 academic hospital centers in the Johannesburg area and the antenatal clinics serving those hospital centers.

You may qualify if:

  • Pregnant women attending participating community/hospital antenatal clinics and/or delivering at participating delivery centers.
  • Subjects aged ≥18 years.
  • Able to understand and comply with planned study procedures.
  • Provides written informed consent.

You may not qualify if:

  • Refuses to consent to study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Respiratory and Meningeal Pathogen Research Unit

Soweto, Gauteng, 2013, South Africa

Location

MeSH Terms

Conditions

Late Onset Disorders

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Novartis Vaccines

    Novartis Vaccines

    STUDY CHAIR
0

Study Design

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

Study Record Dates

First Submitted

March 25, 2014

First Posted

March 28, 2014

Study Start

May 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

July 24, 2014

Record last verified: 2014-07

Locations

ZA(1)