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The purpose of this study is to evaluate safety and reactogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) manufactured by GPO, Thailand, and to evaluate humoral immune response of the above vaccine after intranasal application by using HAI test, micro neutralization assays.
Part A: 24 volunteers will be enrolled and divided into 2 groups -12 volunteers in each of 2 groups receiving either 5.0-6.5 log 10 EID50 or 6.6-7.5 log10 EID50 respectively. 9 who will received vaccine vaccine strain and 3 who will received placebo.
Part B: Total 324 participants will randomized into 2 group using 3:1 ratio (300 vaccines:100 placebos). There are 3 stratified age groups: >12-18 years, >18-49 years and >49 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A/17/CA/2009/38 (H1N1) | Experimental |
| |
| Stabilizer | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccine A/17/CA/2009/38 (H1N1) | Biological | Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systemic reaction and local reaction (vital sign, temperature) | 11/2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Humoral immune response | Peak immunogenicity blood specimen and nasal washing for accessing immune response IgA. Nasal swab on D2, D3, D5, D7 after immunization. Blood for ASC assay at D0 (baseline) and D7 after each dose of vaccine. | 11/2 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof.Punnee Pitisuttithum, MBBS,DTM&HDipGrad | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Tropical Medicine, Mahidol University | Bangkok | 10400 | Thailand |
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| Placebo:Stabilizer | Other | 5% sucrose |
|