Influenza Due to Influenza A Virus Subtype H5N2 Clinical Trial
Official title:
Phase II Safety and Immunogenicity of Live Attenuated Influenza H5 Candidate Vaccine Strain A/17/Turkey/Turkey/05/133 (H5N2) in Healthy Thai Volunteers
| Verified date | July 2017 |
| Source | Mahidol University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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 Thais.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | June 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 49 Years |
| Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Faculty of Tropical Medicine | Bangkok |
| Lead Sponsor | Collaborator |
|---|---|
| Mahidol University | The Government Pharmaceutical Organization, World Health Organization |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Phase II safety and immunogenicity of live attenuated influenza H5 candidate vaccine strain A/17/turkey/Turkey/05/133 (H5N2) in healthy Thai volunteers | within 60 days after screening |