Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008853
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2001-01-18
Brief Title:
Evaluation of Two Type III GBS Polysaccharide-Tetanus Toxoid Conjugate Vaccines
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of Two Type III GBS Polysaccharide-Tetanus Toxoid Conjugate Vaccines
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 50000 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
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 50000 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: