Other Clinical Trial - Antibody Levels Associated With Reduced Risk of

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.

See also
	Status	Clinical Trial	Phase
	Completed	`NCT02215226` - GBS Sero-correlate of Protection

See also

Status

Clinical Trial

Phase

Completed

NCT02215226 - GBS Sero-correlate of Protection

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT02099149
Study type	Observational
Source	Novartis
Contact
Status	Withdrawn
Phase	N/A
Start date	May 2014
Completion date	August 2015

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms