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

NCT ID: NCT00008853

Last Updated: 2010-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2005-11-30

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.

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

Study Design

• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

GBS III-TT-SSI

Intervention Type: BIOLOGICAL

GBS III-TT-MPHL

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

This information currently is not available.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Locations

AIDS Ctr

New York, New York, United States

Countries

United States

Other Identifiers

DMID 97-004

Identifier Type: -

Identifier Source: org_study_id