Comparative Safety and Immunogenicity of VAX128A, VAC128B and VAX128C Novel H1N1 Influenza Vaccine in Healthy Adults
Completed · Phase 1 · Has a placebo group
Conditions studied: Influenza
In brief
This is a multicenter, escalating dose-ranging study to assess the safety, reactogenicity and immunogenicity of 3 different novel H1N1 influenza vaccine constructs delivered i.m. as a single dose vaccination on day 0.
Key facts
- Study ID
- NCT01172054
- Run by
- VaxInnate Corporation
- People needed
- 292
- Starts
- 2010-07-01
- Expected to finish
- 2011-11-01
- Last updated by the study team
- 2012-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy male or female aged 18 - 49 years or >= 65 years
- Give written informed consent
- Females have a negative urine test for pregnancy before vaccination and use birth control during 28 day study period
- Willing to receive the unlicensed (VAX128) vaccine given as an i.m. injection
- Willing to provide multiple blood specimens collected by venipuncture
You may not qualify if…
- Chronic illness that would interfere with the subject's participation in the study or interpretation of the study results.
- Impaired immune responsiveness
- Received drugs effecting the immunity
- Received or plan to receive a nonstudy vaccine within 30 days prior to vaccination and during the study, including licensed influenza vaccines.
- History of anaphylactic type reaction to injected vaccines.
- History of drug abuse in the year prior to screening.
- History of Guillain-Barré Syndrome.
- Receipt or donation of blood products
- Acute disease within 72 hours prior to vaccination
- History of heart or lung disease
- Has other conditions that might interfere with study objectives.
Where it is running
- Miami Research Associates — Miami, Florida, United States
- Johnson County Clin-Trials — Lenexa, Kansas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.