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This is an open, randomized, multicenter clinical trial.
Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group 1 | Experimental | Subjects aged 9 to 17 years |
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| Study Group 2 | Experimental | Subjects aged 3 to 8 years |
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| Study Group 3 | Experimental | Subjects aged 6 to 35 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A/H5N1 Inactivated, split-virion pandemic influenza vaccine | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| To describe safety following administration of A/H5N1 inactivated split virion pandemic influenza vaccine. | 21 Days post-vaccination |
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Inclusion Criteria :
All subjects:
Children/Adolescents aged ≥ 2 years to < 18 years:
Infants/toddlers aged ≥ 6 months to < 2 years:
Exclusion Criteria :
All subjects:
Children/Adolescents aged ≥ 2 years to < 18 years:
Infants/toddlers aged ≥ 6 months to < 2 years:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Sanofi Pasteur Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangkok | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19112513 | Derived | Chotpitayasunondh T, Thisyakorn U, Pancharoen C, Pepin S, Nougarede N. Safety, humoral and cell mediated immune responses to two formulations of an inactivated, split-virion influenza A/H5N1 vaccine in children. PLoS One. 2008;3(12):e4028. doi: 10.1371/journal.pone.0004028. Epub 2008 Dec 29. |
| Label | URL |
|---|---|
| Related Info | View source |
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| A/H5N1 Inactivated, split virion pandemic influenza vaccine | Biological | 0.5 mL, Intramuscular |
|
| A/H5N1 Inactivated, split virion pandemic influenza vaccine | Biological | 0.25 mL, Intramuscular |
|
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D009976 | Orthomyxoviridae Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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