Prevention of GBS Colonization Via Immunity

PHASE2CompletedINTERVENTIONAL
Enrollment

667

Participants

Timeline

Start Date

July 31, 2003

Primary Completion Date

December 31, 2008

Study Completion Date

December 31, 2008

Conditions
Beta Haemolytic Streptococcal Infection
Interventions
BIOLOGICAL

GBS III-TT

50 mcg GBS Type III capsular polysaccharide conjugated to 32 mcg of tetanus toxoid. A single dose of vaccine administered by intramuscular (IM) injection in the upper arm. All subjects will receive a volume of 0.5 ml.

BIOLOGICAL

Tetanus and diptheria toxoids vaccine

Td vaccine is a sterile solution of alum-precipitated toxoids in isotonic sodium chloride solution. A single dose of vaccine will be administered by intramuscular (IM) injection in the upper arm. All subjects will receive a volume of 0.5 ml. Each 0.5 ml dose is formulated to contain 5 Lf (flocculation units) of tetanus toxoid and 2 Lf of diphtheria toxoid.

Trial Locations (3)

15213

Magee-Womens Hospital, Pittsburgh

30912

Medical College of Georgia, Augusta

77004

Planned Parenthood of Houston and Southeast Texas, Inc., Houston

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00128219 - Prevention of GBS Colonization Via Immunity | Biotech Hunter | Biotech Hunter