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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: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00008853 record still lists
NCT00008853 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which GBS III-TT-SSI is the first listed.
NCT00008853 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00008853's enrollment target sits among peer trials
65 798th of 2000 higher than 1,193 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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