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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01317758
The ClinicalTrials.gov registry entry for NCT01317758 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 245 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 3 interventions - of which Phosphate Buffered Saline (PBS) diluent is the first listed.
NCT01317758 reports 0 study locations.
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.
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