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NCT01006798 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of Replication-Competent Adenovirus 4-vectored Vaccine for Avian Influenza H5N1
A Phase 1 study, sponsored by Emergent BioSolutions.
- Completed
- Registry status
- Phase 1
- Development phase
- 166
- Enrollment target
NCT01006798: Completed Phase 1 study, sponsored by Emergent BioSolutions.
NCT01006798 is a Phase 1 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 166 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (177% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01006798, a Phase 1 study, has completed, sponsored by Emergent BioSolutions.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 166 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the safety and immunogenicity over a 9-month period of five different dosages of Ad4-H5-Vtn in volunteers (Vaccinees) who receive three doses of the study vaccine or placebo. In addition, transmission of Ad4-H5-Vtn will be evaluated in all Household Contacts residing with the vaccinated volunteers. Vaccinees also may participate in a substudy in which they receive a booster vaccination with the licensed Influenza Virus Vaccine, H5N1 (Sanofi Pasteur).
Interventions
- OTHER Placebo
- BIOLOGICAL Ad4-H5-Vtn
- BIOLOGICAL Sanofi Pasteur Influenza Virus Vaccine, H5N1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2009-10 |
| Est. Completion | 2011-09 |
| Phase | Phase 1 |
What the finished NCT01006798 record still lists
NCT01006798 is an interventional study that assigns participants to a tested intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (177% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01006798 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01006798 about?
NCT01006798 is a clinical study titled "Safety and Immunogenicity of Replication-Competent Adenovirus 4-vectored Vaccine for Avian Influenza H5N1". The purpose of this study is to compare the safety and immunogenicity over a 9-month period of five different dosages of Ad4-H5-Vtn in volunteers (Vaccinees) who receive three doses of the study vaccine or placebo. In addition, transmission of Ad4-H5-Vtn will be evaluated in all Household Contacts r...
What is the current status of trial NCT01006798?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 166 participants. The study started on 2009-10. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01006798?
The interventions under investigation include: Placebo (OTHER), Ad4-H5-Vtn (BIOLOGICAL), Sanofi Pasteur Influenza Virus Vaccine, H5N1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01006798?
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 NCT01006798's enrollment target sits among peer trials
166 330th of 2000 higher than 1,669 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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