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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 is a Phase 1 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 166 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01006798
The ClinicalTrials.gov registry entry for NCT01006798 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 166 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 3 interventions - of which Placebo is the first listed.
NCT01006798 reports 0 study locations.
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.
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