Status:
COMPLETED
Safety and Immunogenicity of Live Attenuated Influenza H5N2
Lead Sponsor:
Mahidol University
Collaborating Sponsors:
The Government Pharmaceutical Organization
World Health Organization
Conditions:
Influenza Due to Influenza A Virus Subtype H5N2
Eligibility:
All Genders
18-49 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate immune response and safety of live attenuated influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) manufactured by GPO, Thailand in healthy T...
Detailed Description
It is a double blind randomized study using 7.5-8.5 log EID50 dose which is the same dose as being tested in phase I. 150 participants (100 vaccinees and 50 placebos) age 18-49 years old will be enro...
Eligibility Criteria
Inclusion
- Healthy
- Age 18-49 years old
- Having Thai ID card or equivalent
- Are seronegative to the specific H5 influenza virus determined by antibody titer less than 1:40 by HAI test to the corresponding antigen.
- Anti HIV - Negative
- All hematology, biochemistry and urine analysis are within normal range or of no clinical significance (not more than 1.5 times of normal value)
- Able to read and write and sign written informed consent.
Exclusion
- Known history of egg allergy
- Having had recently influenza infection confirmed as H5
- History of bronchial asthma
- History of chronic lung diseases
- History of chronic rhinitis
- History of immunodeficiency state
- History of immunosuppression
- History of heavy smoking (more than 5 rolls per day)
- History of alcoholic (pure drink 200 ml per day)
- Acute infectious and noninfectious diseases (within 2 weeks)
- Exacerbation of chronic diseases or cancer or HIV positives
- Anamnestic leukocytosis, hepatitis B and C positives
- The volunteers who have been taking immunoglobulin products or have had a blood transfusion during past three months before the beginning of the experiment
- Participation in other research study or stop participant less than 1 month
- Pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding
- Any concomitant medication with Aspirin
- Poultry workers
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01841918
Start Date
January 1 2013
End Date
June 1 2013
Last Update
January 31 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Faculty of Tropical Medicine
Bangkok, Thailand, 10400