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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational

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

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.

Detailed Summary:
Sponsor: Novartis

Current Primary Outcome: Early onset Group B Streptococcus Disease due to serotypes Ia or III [ Time Frame: 0-6 days ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome: Late onset Group B Streptococcus Disease due to serotype III [ Time Frame: 7-90 days ]

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


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: March 25, 2014
Date Started: May 2014
Date Completion: August 2015
Last Updated: July 23, 2014
Last Verified: July 2014