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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00008853
First received: January 18, 2001
Last updated: August 26, 2010
Last verified: November 2005
  Purpose

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.


Condition Intervention Phase
Bacterial Infections
Group B Streptococcus
Biological: GBS III-TT-SSI
Biological: GBS III-TT-MPHL
Phase 1

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Evaluation of Two Type III GBS Polysaccharide-Tetanus Toxoid Conjugate Vaccines

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 65
Estimated Study Completion Date: November 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

This information currently is not available.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00008853

Locations
United States, New York
AIDS Ctr
New York, New York, United States, 10011
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00008853     History of Changes
Other Study ID Numbers: DMID 97-004
Study First Received: January 18, 2001
Last Updated: August 26, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Clinical Evaluation

Additional relevant MeSH terms:
Bacterial Infections
Tetanus
Clostridium Infections
Gram-Positive Bacterial Infections

ClinicalTrials.gov processed this record on August 19, 2014