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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 two trail is to evaluate the immunogenicity of LAVI (non freeze- dried). The secondary objective is to evaluate the safety of LAVI (non freeze- dried).
Totally 2520 health people aged 3-59 years old will be divided into two age group, containing 1260 in 18-59 years old and 1260 in 3-19 years old. All subjects will receive vaccination either LAVI(non freeze- dried), LAVI(freeze- dried) or placebo in a ratio of 2:2:1.
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 1 | Experimental | Healthy people in experimental group will receive a dose of Live Attenuated Influenza Vaccine (non freeze- dried) |
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| Positive control group | Active Comparator | Healthy people in Positive control group will receive a dose of Live Attenuated Influenza Vaccine ( freeze- dried) |
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| 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(non freeze-dried) | Biological | Live Attenuated Influenza Vaccine Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of participants with positive sIgA as assessed by SAS v9.4 | The Mucosal convention rate of sIgA in all subjects | within 10 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 | Shijiazhuang | Hebei | 050021 | China |
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Totally 2520 health people aged 3-59 years old will be divided into two age group, containing 1260 in 18-59 years old and 1260 in 3-19 years old. All subjects will receive vaccination either LAVI(non freeze- dried), LAVI(freeze- dried) or placebo in a ratio of 2:2:1.
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The design of this trail is based on random, one-blind, placebo control. The subjects will not know the masking status, unless the specific subjects who required treatment for serious adverse events .
| Live Attenuated Influenza Vaccine(freeze-dried) | Biological | Live Attenuated Influenza Vaccine Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus. |
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| Live Attenuated Influenza Vaccine placebo | Biological | Live Attenuated Influenza Vaccine placebo, not containing H1, H3 and B type influenza Live Attenuated virus. |
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