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NCT00008853 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Two Type III GBS Polysaccharide-Tetanus Toxoid Conjugate Vaccines
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
NCT00008853 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 65 participants.
The verdict
NCT00008853, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL GBS III-TT-SSI
- BIOLOGICAL GBS III-TT-MPHL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Est. Completion | 2005-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00008853
The ClinicalTrials.gov registry entry for NCT00008853 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which GBS III-TT-SSI is the first listed.
NCT00008853 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00008853 about?
NCT00008853 is a clinical study titled "Evaluation of Two Type III GBS Polysaccharide-Tetanus Toxoid Conjugate Vaccines". 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...
What is the current status of trial NCT00008853?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. Estimated completion is 2005-11.
What interventions are being tested in trial NCT00008853?
The interventions under investigation include: GBS III-TT-SSI (BIOLOGICAL), GBS III-TT-MPHL (BIOLOGICAL).
Who is sponsoring clinical trial NCT00008853?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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