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NCT02624219 · ClinicalTrials.gov registry record · Phase 1
H5N8 Mix and Match With or Without AS03 or MF59 in Healthy Adults
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 276
- Enrollment target
NCT02624219 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 276 participants.
The verdict
NCT02624219, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 276 participants
- Enrollment target
Study Summary
This is a Phase I randomized, double-blind, controlled trial in 275 males and non-pregnant females, 19 to 64 years old, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of a monovalent inactivated influenza A/H5N8 virus vaccine manufactured by bioCSL administered at different dosages (7.5 or 15 mcg of HA/0.5 mL dose) given with or without AS03 or MF59 adjuvants manufactured by GlaxoSmithKline Biologicals and Novartis Vaccines and Diagnostics, respectively.
Interventions
- DRUG AS03
- BIOLOGICAL Monovalent Influenza A/H5N8 vaccine
- DRUG MF59 adjuvant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2016-08-16 |
| Est. Completion | 2018-01-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02624219
The ClinicalTrials.gov registry entry for NCT02624219 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 276 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 AS03 is the first listed.
NCT02624219 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02624219 about?
NCT02624219 is a clinical study titled "H5N8 Mix and Match With or Without AS03 or MF59 in Healthy Adults". This is a Phase I randomized, double-blind, controlled trial in 275 males and non-pregnant females, 19 to 64 years old, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of a monovalent inacti...
What is the current status of trial NCT02624219?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 276 participants. The study started on 2016-08-16. Estimated completion is 2018-01-30.
What interventions are being tested in trial NCT02624219?
The interventions under investigation include: AS03 (DRUG), Monovalent Influenza A/H5N8 vaccine (BIOLOGICAL), MF59 adjuvant (DRUG).
Who is sponsoring clinical trial NCT02624219?
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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