Status:
COMPLETED
Comparative Safety and Immunogenicity of VAX128A, VAC128B and VAX128C Novel H1N1 Influenza Vaccine in Healthy Adults
Lead Sponsor:
VaxInnate Corporation
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 vacc...
Detailed Description
VAX128-01 is a first in human study of three inactivated recombinant novel H1N1 influenza vaccines, designated VAX128 A, B and C. The purpose of the study is to compare the safety and immunogenicity o...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
292 Patients enrolled
Trial Details
Trial ID
NCT01172054
Start Date
July 1 2010
End Date
November 1 2011
Last Update
July 31 2012
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Miami Research Associates
Miami, Florida, United States, 33143
2
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219