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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 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. The trial reports 6 study locations across 5 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03589807
The ClinicalTrials.gov registry entry for NCT03589807 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 180 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 2 conditions, with Avian Influenza appearing as the primary indexed condition, and to 4 interventions - of which AS03 is the first listed.
NCT03589807 reports 6 study locations spanning 5 distinct geographic areas - top geographies include 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.
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