Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03014310 · ClinicalTrials.gov registry record · Phase 1
H5N8 Mix and Match With or Without AS03 or MF59 in Healthy Adults: Immunology
A Phase 1 study of Avian Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 388
- Enrollment target
- 7
- Study locations
NCT03014310 is a Phase 1 study of Avian Influenza that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 388 participants. The trial reports 7 study locations across 7 states.
The verdict
NCT03014310, a Phase 1 study of Avian Influenza, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 388 participants
- Enrollment target
- 7
- Study locations
Study Summary
This is a Phase I cohort-randomized, double-blind, controlled trial designed to assess the safety, reactogenicity, and immunogenicity of a monovalent inactivated influenza A/H5N8 virus vaccine administered at different dosages (3.75 and 15 mcg of HA per dose) given with or without AS03 or MF59 adjuvants. This study will be conducted at 6 sites and enroll 150 (up to 380) males and non-pregnant females, 19 to 64 years old, inclusive who are in good health and meet all eligibility criteria. The entire study duration is approximately 24 months and each subject participation duration is approximately 13 months. The primary objectives are: 1) To assess the safety and reactogenicity of a monovalent inactivated influenza A/H5N8 virus vaccine following receipt of two doses administered intramuscularly at different dosages (3.75 and 15 mcg of HA per dose) given with or without AS03 or MF59 adjuvants approximately 21 days apart. 2) To assess the serum HAI and Neut antibody responses to a monovalent inactivated influenza A/H5N8 virus vaccine following receipt of two doses administered intramuscularly at different dosages (3.75 and 15 mcg of HA per dose) given with or without AS03 or MF59 adjuvants approximately 21 days apart.
Conditions Studied
Interventions
- DRUG AS03
- DRUG MF59
- BIOLOGICAL Monovalent Influenza A/H5N8 vaccine
Study Locations (7)
Georgia
- Emory University School of Medicine - Atlanta
Maryland
- University of Maryland Baltimore - School of Medicine - Medicine - Baltimore
Missouri
- Saint Louis University Center for Vaccine Development - St Louis
North Carolina
- Duke Vaccine and Trials Unit - Durham
Ohio
- Cincinnati Children's Hospital Medical Center Vaccine Research Center - Cincinnati
Tennessee
- Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center - Nashville
Texas
- The University of Texas Medical Branch - Sealy Center for Vaccine Development (SCVD) - Galveston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 388 participants |
| Start Date | 2017-01-09 |
| Est. Completion | 2018-12-19 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03014310
The ClinicalTrials.gov registry entry for NCT03014310 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 388 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 1 condition, with Avian Influenza appearing as the primary indexed condition, and to 3 interventions - of which AS03 is the first listed.
NCT03014310 reports 7 study locations spanning 7 distinct geographic areas - top geographies include Georgia, Maryland, Missouri.
Frequently Asked Questions
What is clinical trial NCT03014310 about?
NCT03014310 is a clinical study titled "H5N8 Mix and Match With or Without AS03 or MF59 in Healthy Adults: Immunology". This is a Phase I cohort-randomized, double-blind, controlled trial designed to assess the safety, reactogenicity, and immunogenicity of a monovalent inactivated influenza A/H5N8 virus vaccine administered at different dosages (3.75 and 15 mcg of HA per dose) given with or without AS03 or MF59 adjuv...
What is the current status of trial NCT03014310?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 388 participants. The study started on 2017-01-09. Estimated completion is 2018-12-19.
What conditions does trial NCT03014310 study?
This clinical trial studies the following conditions: Avian Influenza.
What interventions are being tested in trial NCT03014310?
The interventions under investigation include: AS03 (DRUG), MF59 (DRUG), Monovalent Influenza A/H5N8 vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03014310?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03014310 being conducted?
This trial has 7 study locations across Georgia, Maryland, Missouri, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Avian Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.