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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 is a Phase 2 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 187 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00679172
The ClinicalTrials.gov registry entry for NCT00679172 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 187 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emergent BioSolutions, which has 34 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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