NCT00008853

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (planned)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

In this study 65 healthy, non-pregnant women will receive a single dose of one of two anti-streptococcal vaccinations. Both types of vaccinations are given in upper arm by injection into the muscle. To assess the vaccine effectiveness, patients have blood drawn and examined at weeks 4, 8 and 26, post-vaccination.

Conditions

• Bacterial Infections
• Group B Streptococcus

Interventions

Type	Name	Description
BIOLOGICAL	GBS III-TT-SSI
BIOLOGICAL	GBS III-TT-MPHL

Timeline

• Completion: 2005-11-01
• First posted: 2001-08-31
• Last updated: 2010-08-27

Locations

1 site across 1 country: United States