Back to resultsEvaluation of Two Type III GBS Polysaccharide-Tetanus Toxoid Conjugate Vaccines
Primary Purpose
Bacterial Infections, Group B Streptococcus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GBS III-TT-SSI
GBS III-TT-MPHL
Sponsored by
About this trial
This is an interventional prevention trial for Bacterial Infections focused on measuring Clinical Evaluation
Eligibility Criteria
This information currently is not available.
Sites / Locations
- AIDS Ctr
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00008853
First Posted
January 18, 2001
Last Updated
August 26, 2010
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00008853
Brief Title
Evaluation of Two Type III GBS Polysaccharide-Tetanus Toxoid Conjugate Vaccines
Official Title
Evaluation of Two Type III GBS Polysaccharide-Tetanus Toxoid Conjugate Vaccines
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections, Group B Streptococcus
Keywords
Clinical Evaluation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Masking
Double
Enrollment
65 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
GBS III-TT-SSI
Intervention Type
Biological
Intervention Name(s)
GBS III-TT-MPHL
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
This information currently is not available.
Facility Information:
Facility Name
AIDS Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Two Type III GBS Polysaccharide-Tetanus Toxoid Conjugate Vaccines
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