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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: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (402% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Time to first acquisition of vaginal type III GBS was calculated as time from vaccination to the mid-point of the interval of ascertainment, censored by either the end of the follow-up period, or the first of 2 or more consecutive missed visits. Vaginal type III GBS status at missed visits prior to censoring was imputed from the subsequent visit.
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 |
What the finished NCT00128219 record still lists
NCT00128219 is an interventional study that assigns participants to a tested intervention. The registered 667 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (402% higher).
The record links to 0 conditions, and to 2 interventions - of which GBS III-TT is the first listed.
NCT00128219 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00128219's enrollment target sits among peer trials
667 48th of 2000 higher than 1,953 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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