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The aim of this study is to investigate the long-term immunogenicity and safety of the inactivated split-virion vaccine after one immunization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| split-virion, non-adjuvanted vaccine of 15 μg | Experimental | split-virion, non-adjuvanted H1N1 vaccine of 15 μg. |
|
| split-virion, non-adjuvanted vaccine of 30 μg | Experimental | split-virion, non-adjuvanted H1N1 vaccine of 30 μg. |
|
| split-virion, non-adjuvanted vaccine of 45 μg | Experimental | split-virion, non-adjuvanted H1N1 vaccine of 45 μg. |
|
| Placebo control | Placebo Comparator | Placebo control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| split-virion, non-adjuvanted H1N1 vaccine of 15 μg | Biological | 120 adults were assigned to receive 1 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemagglutination inhibition antibody titer | Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| occurrence of solicited local and systemic adverse events after vaccination | Days 0-42 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Provincial Center of Disease Prevention and Control | Changsha | Hunan | 410005 | China |
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| split-virion, non-adjuvanted H1N1 vaccine of 30 μg | Biological | 120 adults were assigned to receive 1 dose of 30μg split-virion, non-adjuvanted H1N1 vaccine. |
|
| split-virion, non-adjuvanted H1N1 vaccine of 45 μg | Biological | 120 adults were assigned to receive 1 dose of 45μg split-virion, non-adjuvanted H1N1 vaccine. |
|
| Placebo control | Biological | 120 adults were assigned to receive 1 dose of placebo. |
|
| 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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