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NCT00311649 · ClinicalTrials.gov registry record · Phase 1
Open Label Evaluation of H5N1 Vaccine at Vaccine Manufacturing Facilities
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 83
- Enrollment target
NCT00311649 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 83 participants.
The verdict
NCT00311649, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 83 participants
- Enrollment target
Study Summary
The purpose of this research is to study side effects and safety of a new H5N1 flu (bird flu) vaccine and to look at how well people's immune systems make antibodies to fight infection after they get the vaccine. Up to 300 healthy people who are working at Aventis Pasteur H5N1 virus vaccine production facility in Swiftwater, PA, during the flu season are being asked to participate. It is important for vaccine production workers to receive the vaccine in order to minimize the risk of this bird flu virus combining with the regular flu virus. Volunteers in this study will have a medical screening, 2 vaccinations a month apart, 2 blood sample collections (1 before and 1 after the vaccinations to compare), 5 clinic visits, and follow-up over 6 months. They will also complete a diary card and to write down their temperature once a day and any symptoms they have every day during the week after they get their second shot. They will also be asked to write down any drugs or medicines they take.
Interventions
- BIOLOGICAL Inactivated Influenza A Vaccine A/H5N1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2005-11 |
| Est. Completion | 2006-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00311649
The ClinicalTrials.gov registry entry for NCT00311649 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Inactivated Influenza A Vaccine A/H5N1 is the first listed.
NCT00311649 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00311649 about?
NCT00311649 is a clinical study titled "Open Label Evaluation of H5N1 Vaccine at Vaccine Manufacturing Facilities". The purpose of this research is to study side effects and safety of a new H5N1 flu (bird flu) vaccine and to look at how well people's immune systems make antibodies to fight infection after they get the vaccine. Up to 300 healthy people who are working at Aventis Pasteur H5N1 virus vaccine producti...
What is the current status of trial NCT00311649?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 83 participants. The study started on 2005-11. Estimated completion is 2006-09.
What interventions are being tested in trial NCT00311649?
The interventions under investigation include: Inactivated Influenza A Vaccine A/H5N1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00311649?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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