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NCT00679172 · ClinicalTrials.gov registry record · Phase 2
Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults
A Phase 2 study, sponsored by Emergent BioSolutions.
- Completed
- Registry status
- Phase 2
- Development phase
- 187
- Enrollment target
NCT00679172: Completed Phase 2 study, sponsored by Emergent BioSolutions.
NCT00679172 is a Phase 2 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 187 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00679172, a Phase 2 study, has completed, sponsored by Emergent BioSolutions.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 187 participants
- Enrollment target
Study Summary
This study is to investigate the safety, tolerability and immunogenicity of the typhoid fever vaccine candidate M01ZH09 manufactured at commercial scale, at a new manufacturing facility. The vaccine will be delivered as a single oral dose to healthy, typhoid vaccine-naïve adults.
Primary Outcome
Number and proportion of subjects reporting suspected unexpected serious adverse reactions (SUSARs).
Interventions
- BIOLOGICAL Dose of 5.0 x 10^9 CFU (Cohort 1)
- BIOLOGICAL Dose of 7.5 x 10^9 CFU (Cohort 2)
- BIOLOGICAL Dose of 1.1 x 10^10 CFU (Cohort 3)
- BIOLOGICAL Dose of of 1.7 x 10^10 CFU (Cohort 4)
- OTHER Placebo (Cohorts 1-4 pooled)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2008-05 |
| Est. Completion | 2008-12 |
| Phase | Phase 2 |
What the finished NCT00679172 record still lists
NCT00679172 is an interventional study that assigns participants to a tested intervention. The registered 187 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 (41% higher).
The record links to 0 conditions, and to 5 interventions - of which Dose of 5.0 x 10^9 CFU (Cohort 1) is the first listed.
NCT00679172 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00679172 about?
NCT00679172 is a clinical study titled "Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults". This study is to investigate the safety, tolerability and immunogenicity of the typhoid fever vaccine candidate M01ZH09 manufactured at commercial scale, at a new manufacturing facility. The vaccine will be delivered as a single oral dose to healthy, typhoid vaccine-naïve adults.
What is the current status of trial NCT00679172?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 187 participants. The study started on 2008-05. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00679172?
The interventions under investigation include: Dose of 5.0 x 10^9 CFU (Cohort 1) (BIOLOGICAL), Dose of 7.5 x 10^9 CFU (Cohort 2) (BIOLOGICAL), Dose of 1.1 x 10^10 CFU (Cohort 3) (BIOLOGICAL), Dose of of 1.7 x 10^10 CFU (Cohort 4) (BIOLOGICAL), Placebo (Cohorts 1-4 pooled) (OTHER).
Who is sponsoring clinical trial NCT00679172?
This trial is sponsored by Emergent BioSolutions, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00679172's enrollment target sits among peer trials
187 357th of 2000 higher than 1,644 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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