Status:
COMPLETED
Immunogenicity and Safety Study of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Primed Adults
Lead Sponsor:
UMN Pharma Inc.
Conditions:
Influenza
Eligibility:
All Genders
21-41 years
Phase:
PHASE2
Brief Summary
The study is designed to assess the immunogenicity and safety of one booster vaccination with 45 μg of a recombinant H5N1 influenza (A/Indonesia/05/2005) HA vaccine in healthy young adults, previously...
Eligibility Criteria
Inclusion
- Subjects who completed a priming study (JPIP501-01a, NCT00980447)
- Male and female healthy adults
- Written informed consent obtained from the subject before study entry
Exclusion
- History of H5N1 influenza or vaccination of other H5N1 influenza vaccines
- Clinically diagnosed cardiovascular, hematological, psychological, neurological, hepatic, renal, pulmonary (including asthma), endocrinological or gastrointestinal disorder
- Confirmed immune deficiency conditions, or diagnosed autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus
- Severe allergic reactions or anaphylaxis to foods or drugs (including vaccines)
- Treatment with disallowed drugs including other study drugs
- Pregnant or nursing (lactating) women
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT01195038
Start Date
October 1 2010
End Date
January 1 2011
Last Update
February 8 2011
Active Locations (2)
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1
UMN Investigational Site
Osaka, Japan
2
UMN Investigational Site
Tokyo, Japan