Antibody Levels Associated With Reduced Risk of Invasive Group B Streptococcus Disease in Infants Aged Less Than 90 Days

Invasive Group B Streptococcus Disease Clinical Trial

Official title:

Establishing a Sero-correlate of Protection Against Invasive Group B Streptococcus Disease in Newborns and Young Infants Aged Less Than 90 Days.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02099149
• Other study ID #: V98_28OB
• Status: Withdrawn
• Phase: N/A
• First received: March 25, 2014
• Last updated: July 23, 2014
• Start date: May 2014
• Est. completion date: August 2015

Study information

• Verified date: July 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Refuses to consent to study participation.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Invasive Group B Streptococcus Disease

Locations

Country	Name	City	State
South Africa	Respiratory and Meningeal Pathogen Research Unit	Soweto	Gauteng

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Novartis Vaccines

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Late onset Group B Streptococcus Disease due to serotype III	Risk of late onset Group B Streptococcus disease (due to serotypes III) with respect to maternal or newborn anticapsular antibody levels at delivery	7-90 days	No