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NCT00008853 Clinical Trial

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

Bacterial Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00008853
Other study ID # DMID 97-004
Secondary ID
Status Completed
Phase Phase 1
First received January 18, 2001
Last updated August 26, 2010
Est. completion date November 2005

Study information
Verified date November 2005
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date November 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility This information currently is not available.

Study Design

Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• GBS III-TT-SSI

• GBS III-TT-MPHL

Locations
Country Name City State
United States AIDS Ctr New York New York

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

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