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NCT00908687 · ClinicalTrials.gov registry record · Phase 2
A/H5N1/LT Dose Ranging Study
A Phase 2 study, sponsored by Intercell USA.
- Completed
- Registry status
- Phase 2
- Development phase
- 500
- Enrollment target
NCT00908687: Completed Phase 2 study, sponsored by Intercell USA.
NCT00908687 is a Phase 2 study that has completed, run by Intercell USA. The registered enrollment target is 500 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (276% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00908687, a Phase 2 study, has completed, sponsored by Intercell USA.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 500 participants
- Enrollment target
Study Summary
This is a Phase 2, randomized, blinded, clinical trial. Up to 500 eligible subjects will be enrolled and randomized in a 1:2:2:1:2:2 ratio into one of six groups, and vaccinated in this study. Subjects will receive an intramuscular injection of the influenza A/H5N1 (low or high dose) on Day 0 with or without a patch (low or high dose).
Primary Outcome
Seroconversion is defined as either 1) baseline HI titer \< 1:10 and a post-vaccination HI titer ≥ 1:40, or 2) baseline HI titer ≥ 1:10 and a minimum four-fold rise. Seroprotection is defined as a post-vaccination HI antibody titer ≥ 1:40. FDA/EMEA criterion for seroconversion was to meet or exceed 40%. FDA/EMEA criterion for seroprotection was to meet or exceed 70%.
Interventions
- BIOLOGICAL A/H5N1
- BIOLOGICAL LT Adjuvant Patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2009-05 |
| Est. Completion | 2011-07 |
| Phase | Phase 2 |
What the finished NCT00908687 record still lists
NCT00908687 is an interventional study that assigns participants to a tested intervention. The registered 500 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 (276% higher).
The record links to 0 conditions, and to 2 interventions - of which A/H5N1 is the first listed.
NCT00908687 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00908687 about?
NCT00908687 is a clinical study titled "A/H5N1/LT Dose Ranging Study". This is a Phase 2, randomized, blinded, clinical trial. Up to 500 eligible subjects will be enrolled and randomized in a 1:2:2:1:2:2 ratio into one of six groups, and vaccinated in this study. Subjects will receive an intramuscular injection of the influenza A/H5N1 (low or high dose) on Day 0 with o...
What is the current status of trial NCT00908687?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 500 participants. The study started on 2009-05. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00908687?
The interventions under investigation include: A/H5N1 (BIOLOGICAL), LT Adjuvant Patch (BIOLOGICAL).
Who is sponsoring clinical trial NCT00908687?
This trial is sponsored by Intercell USA, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00908687's enrollment target sits among peer trials
500 70th of 2000 higher than 1,927 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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