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The purpose of this study is to observe the adverse reaction ratio and hemagglutination inhibition (HI) antibody positive rate, Geometric mean titer (GMT) of three brands split influenza virus vaccine in different population.
Observational Objectives:
To describe the safety of evaluated vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to ≤ 36 months,6th to 12th birthday and ≥ 60th birthday.
To describe the immunogenicity of evaluated vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to ≤ 36 months, 6th to 12th birthday and ≥ 60rd birthday.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| evaluated vaccine | Experimental | 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose) |
|
| imported compared vaccine | Active Comparator | 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose) |
|
| domestic compared vaccine | Active Comparator | 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| evaluated vaccine | Biological | 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the immunogenicity of evaluated vaccine | The immunologic equivalence of 7days after vaccination of influenza virus vaccine was measured in terms of GMTs. | 6 months |
| To evaluate the safety | The incidence of adverse events was analyzed statistically | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nianmin Shi, Master | Beijing Chaoyang District Center for Disease Control and Prevention | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanhe Centre for Disease Control and Prevention | Langfang | Hebei | China | |||
| Jiuyuan Center for Disease Control and Prevention |
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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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| imported compared vaccine | Biological | 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose) |
|
| domestic compared vaccine | Biological | 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose) |
|
| Baotou |
| Inner Mongolia |
| China |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |