Phase I Safety and Immunogenicity Study of VAX102 [Flagellin.HuM2e] Influenza Vaccine in Healthy Adults
Completed · Phase 1 · Has a placebo group
Conditions studied: Influenza Infection
In brief
This study will evaluate the safety and immunogenicity of VAX102 \[Flagellin.HuM2e\], a recombinant, inactivated, subunit influenza vaccine given as a two dose regimen at a range of doses.
Key facts
- Study ID
- NCT00603811
- Run by
- VaxInnate Corporation
- People needed
- 60
- Starts
- 2007-09-01
- Expected to finish
- 2008-10-01
- Last updated by the study team
- 2014-09-23
Who can join
Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy adults aged 18-49 years inclusive who provide written informed consent to participate.
- Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
You may not qualify if…
- Presence of significant acute or chronic, uncontrolled medical or psychiatric illness
- Documented influenza infection in the 6 months prior to study entry.
- Presently receiving or history of receiving any medications or treatments that affects the immune system
- Acute disease within 72 hours prior to vaccinations Investigational product (test article) administrations will occur on Days 0 and 28 (± 3).
- In-clinic safety evaluations will be performed at screening, before each test article dose, and at Days 1, 7 (± 2), 14 (± 2), 29, 35 (± 2), 42 (± 2), 60 (± 2), 120 (± 7), and 180 (± 7).
- Completion of a Memory Aid for seven days following each vaccine dose will be requested of subjects for use in accurate recall of local and systemic reactions.
Where it is running
- Johnson County Clinical Trials — Lenexa, Kansas, United States
- Sealy Vaccine Center, UTMB — Galveston, Texas, United States
Full record on ClinicalTrials.gov
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