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

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

Patrocinadores

Patrocinador principal: National Institute of Allergy and Infectious Diseases (NIAID)

Fuente National Institute of Allergy and Infectious Diseases (NIAID)
Resumen breve

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.

Descripción detallada

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.

Estado general Completed
Fecha de Terminación November 2005
Fase Phase 1
Tipo de estudio Interventional
Inscripción 65
Condición
Intervención

Tipo de intervención: Biological

Nombre de intervención: GBS III-TT-SSI

Tipo de intervención: Biological

Nombre de intervención: GBS III-TT-MPHL

Elegibilidad

Criterios:

This information currently is not available.

Género: Female

Edad mínima: 18 Years

Edad máxima: 45 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Ubicación
Instalaciones: AIDS Ctr
Ubicacion Paises

United States

Fecha de verificación

November 2005

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Información de diseño del estudio

Propósito primario: Prevention

Enmascaramiento: Double

Fuente: ClinicalTrials.gov