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NCT03589807 · ClinicalTrials.gov registry record · Phase 2
2013/2017 H7N9 Prime-Boost Interval
A Phase 2 study of Avian Influenza and Influenza Immunisation, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
- 6
- Study locations
NCT03589807: Completed Phase 2 study of Avian Influenza and Influenza Immunisation, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03589807 is a Phase 2 study of Avian Influenza and Influenza Immunisation that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 180 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03589807, a Phase 2 study of Avian Influenza and Influenza Immunisation, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is a trial designed to assess the safety, reactogenicity and immunogenicity of one or two doses of monovalent inactivated split influenza 2013 and 2017 A/H7N9 virus vaccines administered intramuscularly at different dosages, given with or without AS03 adjuvant, using different vaccination schedules. This trial will enroll up to 180 males and non-pregnant females, 19 to 50 years of age, who are in good health and who are influenza A/H7 naïve. Subjects will be randomly assigned to 1 of 6 treatment arms (30 subjects per arm) to evaluate the interval between the first and second doses and the presence of the adjuvant in the first and second doses. The neuraminidase-specific antibody response and the neuraminidase content of the Inactivated Influenza Virus Vaccine will be determined using tests that are currently under development. Study duration is approximately 22 months with subject participation duration of approximately 18 months. The primary objectives of the study are: 1) to assess the safety and reactogenicity of 2013 and 2017 A/H7N9 IIVs given with or without AS03 adjuvant following receipt of each study vaccine; 2) to assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses following receipt of the second study vaccine.
Primary Outcome
Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days post second study vaccination (Day 43).
Conditions Studied
Interventions
- DRUG AS03
- OTHER Phosphate Buffered Saline (PBS) diluent
- BIOLOGICAL A/H7N9
- BIOLOGICAL Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013
Study Locations (6)
Georgia
- Emory Children's Center - Pediatric Infectious Diseases - Atlanta
- Emory Vaccine Center - The Hope Clinic - Decatur
Iowa
- University of Iowa - Vaccine Research and Education Unit - Iowa City
Missouri
- Saint Louis University - Center for Vaccine Development - St Louis
North Carolina
- Duke Human Vaccine Institute - Duke Vaccine and Trials Unit - Durham
Texas
- Baylor College of Medicine - Molecular Virology and Microbiology - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2018-08-21 |
| Est. Completion | 2020-06-14 |
| Phase | Phase 2 |
What the finished NCT03589807 record still lists
NCT03589807 is an interventional study that assigns participants to a tested intervention. The registered 180 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 (35% higher).
The record links to 2 conditions, with Avian Influenza appearing as the primary indexed condition, and to 4 interventions - of which AS03 is the first listed.
NCT03589807 lists 6 locations in 5 states (Georgia, Iowa, Missouri).
Frequently Asked Questions
What is clinical trial NCT03589807 about?
NCT03589807 is a clinical study titled "2013/2017 H7N9 Prime-Boost Interval". This is a trial designed to assess the safety, reactogenicity and immunogenicity of one or two doses of monovalent inactivated split influenza 2013 and 2017 A/H7N9 virus vaccines administered intramuscularly at different dosages, given with or without AS03 adjuvant, using different vaccination sched...
What is the current status of trial NCT03589807?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2018-08-21. Estimated completion is 2020-06-14.
What conditions does trial NCT03589807 study?
This clinical trial studies the following conditions: Avian Influenza, Influenza Immunisation.
What interventions are being tested in trial NCT03589807?
The interventions under investigation include: AS03 (DRUG), Phosphate Buffered Saline (PBS) diluent (OTHER), A/H7N9 (BIOLOGICAL), Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03589807?
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 NCT03589807 being conducted?
This trial has 6 study locations across Georgia, Iowa, Missouri, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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.
Where NCT03589807's enrollment target sits among peer trials
180 365th of 2000 higher than 1,610 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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