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NCT01658800 · ClinicalTrials.gov registry record · Phase 1
Study of the Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49
A Phase 1 study, sponsored by VaxInnate Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 275
- Enrollment target
NCT01658800: Completed Phase 1 study, sponsored by VaxInnate Corporation.
NCT01658800 is a Phase 1 study that has completed, run by VaxInnate Corporation. The registered enrollment target is 275 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (358% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01658800, a Phase 1 study, has completed, sponsored by VaxInnate Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 275 participants
- Enrollment target
Study Summary
The purpose of this study is to test an investigational vaccine known as "VAX161C." An "investigational" vaccine is one that is not licensed for commercial use in the by the United States (US) by the US Food and Drug Administration (FDA). VAX161C is a vaccine for the influenza A virus subtype H5N1 avian influenza virus (bird flu). In this study, the subject will receive the VAX161C vaccine at one of six doses to see which dose is the best. VaxInnate wants to find out how safe these doses of vaccines are and how well they are tolerated by people who receive them. To measure how effective each type of the vaccine is, VaxInnate will test the ability of the body to develop an immune response, which means how the body recognizes and defends itself against the influenza virus.
Primary Outcome
Assess safety, reactogenicity and tolerability. Symptoms will be collected from the memory aid adn 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 (headace, 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 sever
Interventions
- BIOLOGICAL VAX161C vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 275 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
What the finished NCT01658800 record still lists
NCT01658800 is an interventional study that assigns participants to a tested intervention. The registered 275 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 (358% higher).
The record links to 0 conditions, and to 1 intervention - of which VAX161C vaccine is the first listed.
NCT01658800 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01658800 about?
NCT01658800 is a clinical study titled "Study of the Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49". The purpose of this study is to test an investigational vaccine known as "VAX161C." An "investigational" vaccine is one that is not licensed for commercial use in the by the United States (US) by the US Food and Drug Administration (FDA). VAX161C is a vaccine for the influenza A virus subtype H5N1 a...
What is the current status of trial NCT01658800?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 275 participants. The study started on 2012-09. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01658800?
The interventions under investigation include: VAX161C vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01658800?
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 NCT01658800's enrollment target sits among peer trials
275 149th of 2000 higher than 1,852 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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