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

NCT00008853 | Completed Phase 1

• 1 other identifier: DMID 97-004
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bacterial Infections; Group B Streptococcus

Keywords

Clinical Evaluation

Interventions

GBS III-TT-SSI BIOLOGICAL

GBS III-TT-MPHL BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

This information currently is not available.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

AIDS Ctr

New York, New York, 10011, United States

Location

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 18, 2001
• First Posted: August 31, 2001
• Study Completion: November 1, 2005
• Last Updated: August 27, 2010

Record last verified: 2005-11

Locations

US (1)