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| Name | Class |
|---|---|
| He Bei province Center for Disease control and prevention | UNKNOWN |
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Live Attenuated freeze-dried Influenza Vaccine has been licensed for use in 2020 (Approval No.S20200002), the sponsor of this research submitted an new application for non freeze-dried Live Attenuated Influenza Vaccine in 2021. The main objective of phase â… trail is to evaluate the safety of LAVI(non freeze-dried). The secondary objective is to evaluate the immunogenicity of LAVI(non freeze-dried).
Totally 160 health people aged 3-59 years old will be divided into two age group, containing 80 in 18-59 years old and 80 in 3-19 years old. All subjects will receive vaccination either LAVI or placebo in a ratio of 3:1.
All subjects will be collected any adverse events within 30 days and any serious adverse events within 6 months for safety evaluation.
All subjects will be collected blood sample and nasopharyngeal swab for immunogenicity evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Healthy people in experimental group will receive a dose of Live Attenuated Influenza Vaccine |
|
| Placebo group | Placebo Comparator | Healthy people in placebo group will receive a dose of placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live Attenuated Influenza Vaccine | Biological | Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as assessed by SAS v9.4 | The incidence rate of adverse events in all subjects | Within 31 days after vaccination |
| Number of participants with laboratory examination abnormity as assessed by SAS v9.4Clinical laboratory examination | The incidence rate of abnormal of Blood routine, blood biochemical and urine in The incidence rate of abnormality of blood routine, blood biochemical and urine routine in 18-59 years age group | 3 days after vaccination |
| Number of participants with virus Shedding as assessed by SAS v9.4 | The nasal secretions of Subjects in 18-59 years age group will be taken and be tested | within 16 days after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Provincial Center for Disease Control and Prevention | Recruiting | Shijiazhuang | Hebei | 050021 | China |
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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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Totally 160 in 3-59 years old healthy people will be divided into two age group, which contain 80 people in 18-59 years old and 80 people in 3-17 years old. In each age group, subjects will be randomly divided into vaccine group and placebo group in a ratio of 3:1.
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The design of this trail is based on random, two-blind, placebo control. The subjects and investigators will not know the masking status, unless the specific subjects who required treatment for serious adverse events .
| Live Attenuated Influenza Vaccine placebo | Biological | Live Attenuated Influenza Vaccine placebo, not containing H1, H3 and B type influenza Live Attenuated virus. |
|