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

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00008853

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 I

MedlinePlus related topics: Bacterial Infections Tetanus

Drug Information available for: Tetanus Vaccine

U.S. FDA Resources

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

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

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

National Institute of Allergy and Infectious Diseases (NIAID)

More Information

Study ID Numbers:	DMID 97-004
Study First Received:	January 18, 2001
Last Updated:	November 11, 2005
ClinicalTrials.gov Identifier:	NCT00008853
Health Authority:	United States: Federal Government

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

Clinical Evaluation

Study placed in the following topic categories:

Bacterial Infections
Tetanus

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on January 16, 2009