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The purpose of this study is to evaluate the immunogenicity and safety of 2012-2013 trivalent seasonal influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy adults aged 18-60 years old, and 60 healthy older people aged > 60 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| trivalent seasonal influenza vaccine | Experimental | 2012-2013 trivalent seasonal influenza vaccine in 60 infants with two-dose regimen, 21 days interval trivalent seasonal influenza vaccine in 60 adults and 60 old people with single-dose regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2012-2013 trivalent seasonal influenza vaccine | Biological | trivalent seasonal influenza vaccine with 0.25 ml ⁄ vial, for infants trivalent seasonal influenza vaccine with 0.5 ml ⁄ vial, for adults and old people |
| Measure | Description | Time Frame |
|---|---|---|
| Hemagglutination inhibition (HI) antibody titer of 2012-2013 trivalent seasonal influenza vaccine | to evaluate the immunogenicity of the vaccine in adults and old people. | 21 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of systemic and local adverse reactions after vaccination | to evaluate the safety of the vaccine in healthy infants, adults, and old people | 0-21 days after vaccination |
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For adults and old people:
Inclusion Criteria:
Exclusion Criteria:
For infants:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wan-Shen Guo, BS | Henan Center for Diseases Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Center for Diseases Control and Prevention | Zhengzhou | Henan | China |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |