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NCT00703053 · ClinicalTrials.gov registry record · Phase 2
H5N1 Priming and Boosting Strategies
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 505
- Enrollment target
NCT00703053: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00703053 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 505 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (280% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00703053, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 505 participants
- Enrollment target
Study Summary
Severe disease in humans due to bird influenza viruses (H5N1) has led to concern that this virus may result in a widespread outbreak of bird flu. The purpose of this study is to evaluate the dose and dosing schedule for 2 different types of H5N1 vaccine. Participants will be randomly assigned to 1 of 9 possible vaccine groups. All participants will receive 2 doses of Clade 1, Clade 2, or combination Clade 1 and 2 on Day 0. All participants will receive a second dose of the same vaccine or a different vaccine type on study day 7, 14, 28 or 180. Study participants will include about 500 healthy adult subjects, ages 18-49 years old, who have no history of prior H5 flu exposure or vaccination. Study procedures may include medical history, physical exam, and blood sampling. Subject participation may last up to 372 days. Several DMID studies have recently evaluated H5N1 vaccines in healthy adults, 04-063, 05-0090, 05-0015, and 05-0043.
Primary Outcome
The GMTs are as assessed by the HAI assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.
Interventions
- BIOLOGICAL A/Vietnam/1203/04
- BIOLOGICAL A/Indonesia/05/05
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 505 participants |
| Start Date | 2008-09 |
| Est. Completion | 2009-11 |
| Phase | Phase 2 |
What the finished NCT00703053 record still lists
NCT00703053 is an interventional study that assigns participants to a tested intervention. The registered 505 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (280% higher).
The record links to 0 conditions, and to 2 interventions - of which A/Vietnam/1203/04 is the first listed.
NCT00703053 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00703053 about?
NCT00703053 is a clinical study titled "H5N1 Priming and Boosting Strategies". Severe disease in humans due to bird influenza viruses (H5N1) has led to concern that this virus may result in a widespread outbreak of bird flu. The purpose of this study is to evaluate the dose and dosing schedule for 2 different types of H5N1 vaccine. Participants will be randomly assigned to 1 o...
What is the current status of trial NCT00703053?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 505 participants. The study started on 2008-09. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00703053?
The interventions under investigation include: A/Vietnam/1203/04 (BIOLOGICAL), A/Indonesia/05/05 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00703053?
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 NCT00703053's enrollment target sits among peer trials
505 69th of 2000 higher than 1,932 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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