Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00311649 record still lists
NCT00311649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% higher).
The record links to 0 conditions, and to 1 intervention - of which Inactivated Influenza A Vaccine A/H5N1 is the first listed.
NCT00311649 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00311649's enrollment target sits among peer trials
83 665th of 2000 higher than 1,332 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02974647 · 83 participants · Phase 2
Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma
- NCT03919292 · 83 participants · Phase 1
Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca
- NCT04626674 · 83 participants · Phase 1
A Gene Transfer Therapy Study to Evaluate the Safety of and Expression From Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD)
- NCT05277168 · 83 participants · Phase 1
A Trial TO Evaluate THE Safety, Tolerability, Pharmacokinetics, AND Efficacy OF Shr-a1904 IN Subjects With Advanced Solid Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia