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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00008853
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : August 27, 2010
Sponsor:
Information provided by:

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.


Condition or disease Intervention/treatment Phase
Bacterial Infections Group B Streptococcus Biological: GBS III-TT-SSI Biological: GBS III-TT-MPHL Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Masking: Double
Primary Purpose: Prevention
Official Title: Evaluation of Two Type III GBS Polysaccharide-Tetanus Toxoid Conjugate Vaccines
Estimated Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
This information currently is not available.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00008853


Locations
United States, New York
AIDS Ctr
New York, New York, United States, 10011
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
More Information

ClinicalTrials.gov Identifier: NCT00008853     History of Changes
Other Study ID Numbers: DMID 97-004
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: August 27, 2010
Last Verified: November 2005

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Clinical Evaluation

Additional relevant MeSH terms:
Bacterial Infections
Tetanus
Clostridium Infections
Gram-Positive Bacterial Infections