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NCT03497845 · ClinicalTrials.gov registry record · Phase 2
Assess the Safety & Immunogenicity of Prime-Boost Vaccination Strategies Using H5Nx Virus Vaccine Adjuvanted With AS03 or MF59
A Phase 2 study, sponsored by Biomedical Advanced Research and Development Authority.
- Completed
- Registry status
- Phase 2
- Development phase
- 720
- Enrollment target
NCT03497845: Completed Phase 2 study, sponsored by Biomedical Advanced Research and Development Authority.
NCT03497845 is a Phase 2 study that has completed, run by Biomedical Advanced Research and Development Authority. The registered enrollment target is 720 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (441% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03497845, a Phase 2 study, has completed, sponsored by Biomedical Advanced Research and Development Authority.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 720 participants
- Enrollment target
Study Summary
The main purpose of this study is to assess the ability of H5 influenza virus vaccines and adjuvants present in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) to generate an immune response to homologous and to antigenically distant heterologous H5 influenza virus strains. The study is designed to evaluate the safety and immunogenicity of vaccination strategies with homologous or antigenically distant heterologous H5 influenza virus vaccines administered with AS03 or MF59 adjuvant.
Primary Outcome
Safety of 2-dose and 3-dose H5 influenza vaccination series as determined by occurrence of mild, moderate, or severe solicited local reactogenicity symptoms. Subjects in A-D and G-J did not receive 3 doses
Interventions
- BIOLOGICAL VN
- BIOLOGICAL IN
- BIOLOGICAL dk/BANG
- BIOLOGICAL gf/WA
- BIOLOGICAL bhg/QL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 720 participants |
| Start Date | 2018-03-15 |
| Est. Completion | 2019-11-19 |
| Phase | Phase 2 |
What the finished NCT03497845 record still lists
NCT03497845 is an interventional study that assigns participants to a tested intervention. The registered 720 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 (441% higher).
The record links to 0 conditions, and to 5 interventions - of which VN is the first listed.
NCT03497845 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03497845 about?
NCT03497845 is a clinical study titled "Assess the Safety & Immunogenicity of Prime-Boost Vaccination Strategies Using H5Nx Virus Vaccine Adjuvanted With AS03 or MF59". The main purpose of this study is to assess the ability of H5 influenza virus vaccines and adjuvants present in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) to generate an immune response to homologous and to antigenically distant heterologous H5 influenza virus strains. The study ...
What is the current status of trial NCT03497845?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 720 participants. The study started on 2018-03-15. Estimated completion is 2019-11-19.
What interventions are being tested in trial NCT03497845?
The interventions under investigation include: VN (BIOLOGICAL), IN (BIOLOGICAL), dk/BANG (BIOLOGICAL), gf/WA (BIOLOGICAL), bhg/QL (BIOLOGICAL).
Who is sponsoring clinical trial NCT03497845?
This trial is sponsored by Biomedical Advanced Research and Development Authority, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03497845's enrollment target sits among peer trials
720 45th of 2000 higher than 1,956 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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