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To explore a bridging index for the effectiveness of the clinical trial with Nasal Spray Lyophilized Live Attenuated Influenza Vaccine
With a randomized, blind, parallel placebo-controlled design, to screen the susceptible individuals aged 3~59 years old whose titers of either of Hi antibody level of H1N1, H3N2 or B are not higher than 1:10 prior immunization , in which all persons are to be assigned into the two subgroups (aged 3~17 and 18~59 years old) with radio of 1:1, individually. All persons of each age subgroups are to be randomly assigned into the two groups (vaccine or placebo group) with th radio of 2:1 via intranasal injection of one dose of the study vaccine or placebo. The blood samples are to be collected prior immunisation and on the 21st day post immunisation, individually, the nasopharyngeal swab samples are also to be done prior immunisation and on the 10th day and 21st day post immunisation, individually, and the levels of serum HI antibody and mucous sIgA antibody are to be compared between the two groups, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study vaccine | Experimental | Nasal Spray Lyophilized Live Attenuated Influenza Vaccine |
|
| Placebo | Placebo Comparator | commercial normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal Spray Lyophilized Live Attenuated Influenza Vaccine | Biological | 0.2 ml/vial, 0.2ml/dose/per person |
|
| Measure | Description | Time Frame |
|---|---|---|
| The GMTs of serum HI antibodies of all H1N1, H3N2 and B | The GMTs of serum HI antibodies of all H1N1, H3N2 and B on the 21st day post immunization; | 0-21 days |
| GMTs of HI sIgA antibodies of all H1N1, H3N2 and B | The mucous GMTs of HI sIgA antibodies of all H1N1, H3N2 and B on the 10th and 21st day post immunization; | 10-21 days |
| Measure | Description | Time Frame |
|---|---|---|
| The ratios and 95% CI of the GMTs of serum HI antibodies of all H1N1, H3N2 and B | The ratios and 95% CI of the GMTs of serum HI antibodies of all H1N1, H3N2 and B on the 21st day post immunization; | 0-21days |
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Inclusion Criteria:
Exclusion Criteria:
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