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

NCT00008853 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2010-08-27

No results posted yet for this study

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

Interventions

BIOLOGICAL

GBS III-TT-SSI

BIOLOGICAL

GBS III-TT-MPHL

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Purpose
PREVENTION
Masking
DOUBLE

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Completion
2005-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00008853 on ClinicalTrials.gov