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This study evaluates the safety of freeze-dried live attenuated influenza vaccine for intranasal administration in chinese adults aged 3 years and older.80 subjects will be divided into 2 groups, including 18 years and older and 3-17 years old. Subjects in each groups will randomly receive one dose of influenza vaccine or placebo in a 3:1 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| one dose of Influenza Vaccine in aged 18 years and older | Experimental | One dose of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in aged 18 years and older |
|
| One dose of Influenza Vaccine in aged 3-17 year | Experimental | One dose of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in aged 3-17 years |
|
| placebo in aged 18 years and older | Placebo Comparator | placebo in 10 subjects aged 18 years and older on day 0 |
|
| placebo in aged 3-17 years | Placebo Comparator | placebo in 10 subjects aged 3-17 years on day 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| one dose of Influenza Vaccine | Biological |
| ||
| one dose of Influenza Vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the rate of adverse reactions of Live Attenuated Influenza Vaccine for Intranasal Administration | Adverse reactions associated with vaccine will be observed in subjects after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Biological |
|
| placebo | Biological |
|
| placebo | Biological |
|
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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