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NCT01317758 · ClinicalTrials.gov registry record · Phase 1
H5N1 Mix and Match With AS03
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 245
- Enrollment target
NCT01317758: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01317758 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 245 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (308% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01317758, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 245 participants
- Enrollment target
Study Summary
Approximately 216, and up to 240, healthy males and non-pregnant females, 18 to 49 years old, inclusive, will be enrolled over a 5-month period into this multicenter, randomized, double-blinded, controlled Phase I study. Subjects who meet the entry criteria for the study and provide informed consent will be randomized 2:1 between adjuvanted and unadjuvanted vaccine and placed into one of 6 groups (see table) to receive two doses of an intramuscular subvirion inactivated monovalent influenza A/H5N1 virus vaccine at 3.75, 7.5, or 15 mcg given with the adjuvant AS03 or diluent (N=216, up to 240). All eligible subjects will receive 2 doses separated by approximately 21 days.
Interventions
- OTHER Phosphate Buffered Saline (PBS) diluent
- DRUG AS03 Adjuvant
- BIOLOGICAL Sanofi H5N1 Antigen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-09 |
| Phase | Phase 1 |
What the finished NCT01317758 record still lists
NCT01317758 is an interventional study that assigns participants to a tested intervention. The registered 245 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (308% higher).
The record links to 0 conditions, and to 3 interventions - of which Phosphate Buffered Saline (PBS) diluent is the first listed.
NCT01317758 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01317758 about?
NCT01317758 is a clinical study titled "H5N1 Mix and Match With AS03". Approximately 216, and up to 240, healthy males and non-pregnant females, 18 to 49 years old, inclusive, will be enrolled over a 5-month period into this multicenter, randomized, double-blinded, controlled Phase I study. Subjects who meet the entry criteria for the study and provide informed consent...
What is the current status of trial NCT01317758?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 245 participants. The study started on 2011-05. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01317758?
The interventions under investigation include: Phosphate Buffered Saline (PBS) diluent (OTHER), AS03 Adjuvant (DRUG), Sanofi H5N1 Antigen (BIOLOGICAL).
Who is sponsoring clinical trial NCT01317758?
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 NCT01317758's enrollment target sits among peer trials
245 189th of 2000 higher than 1,810 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
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