Status:
COMPLETED
Immunogenicity, Safety and Optimal Dose Finding Study of Recombinant Influenza H5N1 Vaccine in Healthy Young Adults
Lead Sponsor:
UMN Pharma Inc.
Conditions:
Influenza
Virus Diseases
Eligibility:
All Genders
20-40 years
Phase:
PHASE2
Brief Summary
UMN-0501 is a purified recombinant influenza HA vaccine (A H5N1/Vietnam/1203/2004). The purpose of the present study is to evaluate immunogenicity, safety and optimal dose among three different doses...
Eligibility Criteria
Inclusion
- Healthy adult as determined by medical history, physical examination, laboratory test, and clinical judgment of the investigator.
- Males and females aged 20-40 years.
- Provides signed informed consent form after received a detailed explanation of the study protocol prior to any study procedures.
Exclusion
- Body Mass Index (BMI) 30 kg/m2 and above.
- Has a history of a A/H5N1 influenza virus infection and subjects had received other A/H5N1 influenza vaccine.
- Has a history of allergic reaction by food and medicine including vaccine, and acute fever illness (greater than 39.0C) within 2 days of vaccination.
- Has a history of Guillain-Barre syndrome or acute disseminated encephalomyelitis (ADEM).
- Has severe allergic diseases.
- Has asthma.
- Has a history of convulsions.
- Has a history of any serious disease.
- Known impairment of imune function.
- Known rheumatism and autoimmune disease.
- Receipt of medicines that would affect evaluation of immunogenicity.
- Receipt of any live virus vaccination or receipt of any inactivated vaccine/toxoid prior to enrollment.
- Blood donation prior to enrollment.
- Receipt of another investigation agent prior to enrollment.
- History of alcohol or drug abuse.
- Females who are pregnant or potentially childbearing or are breastfeeding.
- Ineligible subject based on the judgement of the investigator.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00980447
Start Date
October 1 2009
End Date
December 1 2009
Last Update
February 8 2010
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, Osaka, Japan, 586-8521
2
National Hospital Organization Tokyo Medical Center
Meguro-ku, Tokyo, Japan, 152-8902