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NCT01560793 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49 Years
A Phase 1 study, sponsored by VaxInnate Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 224
- Enrollment target
NCT01560793: Completed Phase 1 study, sponsored by VaxInnate Corporation.
NCT01560793 is a Phase 1 study that has completed, run by VaxInnate Corporation. The registered enrollment target is 224 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (273% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01560793, a Phase 1 study, has completed, sponsored by VaxInnate Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 224 participants
- Enrollment target
Study Summary
This study will evaluate the safety and immunogenicity of VAX161B \[STF2.HA5 H5N1\], a recombinant, inactivated, subunit influenza vaccine given as a two dose regimen at a range of doses.
Primary Outcome
Assess safety, reactogenicity and tolerability. Symptoms will be collected from the memory aid and from the information collected at the clinic visits. All symptoms will be graded according to severity. Response to vaccine will be categorized as local (arm pain, redness, bruising, etc.) or systemic (headache, muscle aches, fatigue, etc.) symptoms. Laboratory tests such as CRP, WBC, LFTs and cytokines collected before and after vaccination will also be analyzed. We will compare the types and seve
Interventions
- BIOLOGICAL VAX161 [STF2.HA5 H5N1]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2012-06 |
| Est. Completion | 2013-11 |
| Phase | Phase 1 |
What the finished NCT01560793 record still lists
NCT01560793 is an interventional study that assigns participants to a tested intervention. The registered 224 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (273% higher).
The record links to 0 conditions, and to 1 intervention - of which VAX161 [STF2.HA5 H5N1] is the first listed.
NCT01560793 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01560793 about?
NCT01560793 is a clinical study titled "Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49 Years". This study will evaluate the safety and immunogenicity of VAX161B \[STF2.HA5 H5N1\], a recombinant, inactivated, subunit influenza vaccine given as a two dose regimen at a range of doses.
What is the current status of trial NCT01560793?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 224 participants. The study started on 2012-06. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01560793?
The interventions under investigation include: VAX161 [STF2.HA5 H5N1] (BIOLOGICAL).
Who is sponsoring clinical trial NCT01560793?
This trial is sponsored by VaxInnate Corporation, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01560793's enrollment target sits among peer trials
224 227th of 2000 higher than 1,773 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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