drugset / Trial / NCT00008853

Evaluation of Two Type III GBS Polysaccharide-Tetanus Toxoid Conjugate Vaccines

NCT00008853 ↗

Double-blindPrevention

Summary

The purpose of this study is to test the safety and favorable immune response to an anti-streptococcal vaccine (a vaccine that treats a common bacterial infection) in healthy non-pregnant women. Group B Streptococcus (GBS) continues to be the single most frequent cause of life-threatening bacterial infection during the first 2 months of life. Further, GBS pregnancy-related morbidity afflicts more than 50,000 women annually in the US. Therefore, active immunization of women is an appealing strategy for the prevention of GBS disease in pregnant women and their infants during the first 3 months of infant life.

Timeline

Start
—
Primary completion
—
Completion
2005-11

Drugs

EvaluationDrugModalityDoseRoute
Subject GBS III-TT-MPHL Vaccine — Intramuscular
Subject GBS III-TT-SSI Vaccine — Intramuscular