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NCT00128219 · ClinicalTrials.gov registry record · Phase 2
Prevention of GBS Colonization Via Immunity
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 667
- Enrollment target
NCT00128219 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 667 participants.
The verdict
NCT00128219, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 667 participants
- Enrollment target
Study Summary
The group B streptococcus (GBS) vaccine study is being done to see if a single vaccination with a GBS type III vaccine can stop women from getting GBS type III bacteria in the vagina. Approximately 600 women, ages 18-40, will be enrolled from the clinical sites participating in this study. Participants will be non-pregnant, sexually active (sex with a male at least once in the last 4 months), and GBS negative in the vagina or rectum at the screening visit. Participants will be randomly assigned to receive the experimental GBS type III vaccine or a licensed vaccine containing Tetanus and Diphtheria Toxoids (Td). Participants will be followed at one month, 2 months and every other month thereafter following vaccination (for vaginal and rectal swab collection and a blood draw) for 1½ years or a total of 10 post vaccination visits.
Interventions
- BIOLOGICAL GBS III-TT
- BIOLOGICAL Tetanus and diptheria toxoids vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 667 participants |
| Start Date | 2003-07 |
| Est. Completion | 2008-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00128219
The ClinicalTrials.gov registry entry for NCT00128219 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 667 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 is the first listed.
NCT00128219 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00128219 about?
NCT00128219 is a clinical study titled "Prevention of GBS Colonization Via Immunity". The group B streptococcus (GBS) vaccine study is being done to see if a single vaccination with a GBS type III vaccine can stop women from getting GBS type III bacteria in the vagina. Approximately 600 women, ages 18-40, will be enrolled from the clinical sites participating in this study. Participa...
What is the current status of trial NCT00128219?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 667 participants. The study started on 2003-07. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00128219?
The interventions under investigation include: GBS III-TT (BIOLOGICAL), Tetanus and diptheria toxoids vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00128219?
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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